Septic ShockPhase 4RESETNCT07035509
Randomized Control Study in REsuscitation of SEpsis Trial
A Phase 4 study testing Pharmaceutical fresh frozen plasma, Normal Saline and Ringer lactate (RL) in people with Septic Shock and Pediatric Critical Illness, run by Fundación Cardioinfantil Instituto de Cardiología at 1 site in Colombia.
Trial summary
Crystalloids vs. Synthetic Plasma for Fluid Resuscitation in Children with Sepsis - REsuscitation of SEpsis Trial (RESET): A Comparative and Feasibility Study This research study, called the REsuscitation of SEpsis Trial (RESET), is a randomized clinical trial comparing crystalloids and synthetic plasma for fluid… Read more about this study
- Who is it for?
- Ages 4 weeks to 18 years
- Conditions the study is for
- Septic Shock, Pediatric Critical Illness
- What is being tested?
- Pharmaceutical fresh frozen plasma, Normal Saline and Ringer lactate (RL)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteColombia
- Study dates
- 1 Jul 2025to 15 Jul 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 weeks to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age: ≥1 month (corrected gestational age) to 18 years.
- Diagnosis of sepsis with at least one of the following conditions:
- Signs of poor perfusion: prolonged capillary refill ≥2 sec, weak peripheral pulses, unexplained metabolic acidosis (base deficit > (-)5.0 mEq/L), altered. mental status, lactate ≥2 mmol/L (sample drawn without tourniquet use. (Appendix 2). OR
- Systolic blood pressure (SBP) below the 5th percentile for age.
- Signed informed consent from the patient's legal guardian.
Who cannot join
- Receipt of ≥2 boluses of NS 0.9% or balanced solution in the last 24 hours for the current sepsis episode (bolus defined as ≥10 mL/kg (max. 500 mL) of NS/RL given in <30 min).
- Known allergic reaction to plasma-derived products.
- Known IgA deficiency.
- Suspected or confirmed congestive heart failure.
- Nephrotic syndrome.
- Known chronic kidney disease with fluid overload or congestive heart failure.
- Diagnosed hemorrhagic dengue fever confirmed by antigen or serology (NS1 or IgM positive).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia1 site
Fundacion CardioInfantil - Instituto de Cardiología
Bogotá, Bogota D.C., 111031
Lorena Acevedo, Msc, 3103496080, lorenaacevedo@gmail.com
About this study
Official title: Randomized Control Study on Normal Saline vs Plasmalite vs Plasma in REsuscitation of SEpsis Trial (RESET) - A Feasibility and Comparative Study
Crystalloids vs. Synthetic Plasma for Fluid Resuscitation in Children with Sepsis - REsuscitation of SEpsis Trial (RESET): A Comparative and Feasibility Study This research study, called the REsuscitation of SEpsis Trial (RESET), is a randomized clinical trial comparing crystalloids and synthetic plasma for fluid resuscitation in children with sepsis. Below, we explain some key aspects you should be aware of.
What is a Clinical Trial? A clinical trial is a type of medical research designed to gather more information on how our bodies respond to medications or other treatments.
Read more
Most new medical treatments must be evaluated in clinical trials before they can be approved by government agencies. These agencies ensure that new treatments are not only safe but also beneficial for patients-what medicine refers to as being "safe and effective." If a new treatment has not yet been approved, it is considered "experimental."
Researchers analyze the results of multiple clinical trials to determine which medications work best and how they function. The advancement of medical science requires the participation of many people in numerous studies worldwide.
What is the Purpose of This Study? This study evaluates whether Octaplas LG helps children and adolescents with sepsis and whether it improves the function of blood vessels inflamed due to infection. Sepsis occurs when an infection severely affects a person's health.
Octaplas LG is a medication approved for use in Colombia. It is known as pharmaceutical plasma and is obtained from voluntary donors worldwide. It undergoes an ultra-detailed sterilization process using the most advanced techniques for processing blood derivatives. In medicine, fresh frozen plasma (FFP) is typically used, which is the equivalent of Octaplas LG but with far fewer industrial sterilization processes. These additional processes in Octaplas LG significantly reduce the risk of transmitting infections.
Although Octaplas LG is approved by INVIMA, its use for fluid resuscitation has not yet been approved.
This study will compare Octaplas LG with normal saline solution and Ringer's lactate, which are commonly used for rehydrating patients. All three treatments will be administered in the same manner.
Why is My Child Being Asked to Participate?
Your child is being invited to participate in this clinical study because:
They are receiving care in the pediatric intensive care unit (PICU). They are between one month and 18 years old. They have been diagnosed with sepsis and require fluid resuscitation. Your child's participation is voluntary. If you decide not to participate, your child will not lose any medical benefits. Your child's doctor has determined that they may be a good candidate for this study. You are free to discuss participation with your family, friends, or another physician.
Some members of your child's healthcare team may also be involved in this research. They are dedicated to your child's care as well as the objectives of this study. However, you are not obligated to participate. If you choose to enroll your child, you will be asked to sign an informed consent form.
How Will My Child Be Assigned to a Treatment Group? Upon admission to the pediatric intensive care unit (PICU), if your child has a confirmed sepsis diagnosis and requires intravenous fluids or plasma to support heart function, they will be randomly assigned to one of the three treatment groups.
Randomization is a research method used in clinical trials to assign patients to study groups in an unbiased way-similar to drawing numbers from a hat. Neither you, your child's doctor, nor the researchers will choose which group your child is placed in. Instead, a computer will randomly assign them to a group.
Treatment Groups:
Group 1: Normal Saline (0.9% Sodium Chloride)
Your child will receive the standard treatment for sepsis, including antibiotics, intravenous fluids, heart function monitoring, mechanical ventilation if needed, and blood pressure medications (vasopressors) if necessary.
Group 2: Ringer's Lactate
In addition to standard sepsis management, your child will receive Ringer's lactate, another commonly used resuscitation fluid in pediatric sepsis.
Group 3: Octaplas LG
In addition to standard sepsis management, your child will receive pharmaceutical synthetic plasma, which contains proteins and essential blood components that have undergone advanced processing to eliminate the risk of infectious disease transmission.
How Many Children Will Participate in This Study? At Fundación Cardioinfantil-Instituto de Cardiología, we are seeking the participation of approximately 150 children in this study.
How Long Will My Child Be in the Study? Your child will remain in their assigned treatment group for up to 28 days from PICU admission or until they no longer require intensive care hospitalization.
Read the detailed description
Protocol Title: Randomized Clinical Trial Comparing Crystalloids vs. Synthetic Plasma for Fluid Resuscitation in Children with Sepsis - REsuscitation of Sepsis Trial (RESET): Feasibility and Comparative Study
Development Phase: Phase IV Study
Sponsor:
Fundación Cardioinfantil - Instituto de Cardiología Children's Hospital of Pittsburgh - Center for Trauma and Transfusion Medicine Research, University of Pittsburgh, Pittsburgh, USA
Medical Sponsor and International Coordinator Dr. Jaime Fernández - Pediatric Intensivist, Head of the Pediatric Intensive Care Unit, Fundación Cardioinfantil, Bogotá, Colombia Dr. Phillip Spinella, MD, FCCM - Pediatric Intensivist, Department of Surgery and Anesthesia, Children's Hospital of Pittsburgh; Emeritus Professor, Department of Surgery and Critical Care, University of Pittsburgh; Director, Center for Trauma and Transfusion Medicine Research, University of Pittsburgh, Pittsburgh, USA
Drug Manufacturer: Octapharma
Study Center: Fundación Cardioinfantil - Bogotá, Colombia
Study Objectives
Primary Objective:
To evaluate the feasibility in terms of efficacy and safety of crystalloids versus synthetic fresh plasma as the initial resuscitation fluid in children presenting with septic shock. Feasibility study.
Secondary Objectives:
- Compare hemodynamic parameters using continuous non-invasive cardiac output monitoring (iCON®) between groups.
- Assess intravascular volume via echocardiography at 6 ± 2, 24 ± 8, and 48 ± 8 hours across groups.
- Compare the total volume of normal saline, lactate, or plasma administered for resuscitation within the first 6, 24, and 48 hours.
- Evaluate net fluid balance at 24 and 48 hours.
- Compare oxygenation parameters (S/F ratio, P/F ratio, oxygenation index) between the two groups at 0, 6, 24, and 48 hours in ventilated children.
- Assess organ dysfunction scores (PELOD, pSOFA, and NP-MODS) daily for 48 hours.
- Compare peak inotropic scores daily over 48 hours.
- Evaluate endothelial injury markers and hemostatic parameters.
- Assess inflammatory markers and coagulation activation measures.
- Monitor transfusion-related reactions.
- Compare healthcare-associated infections.
- Assess 28-day mortality and cause of death.
Study Design A prospective, randomized, open-label, feasibility-controlled trial.
Investigational Medicinal Product
Patients diagnosed with septic shock who meet the inclusion criteria will be randomly assigned to one of three intervention arms:
- Group A: Bolus dose of 10 mL/kg normal saline (NS) (max. 500 mL) administered over <15 minutes.
- Group B: Bolus dose of 10 mL/kg Ringer's lactate (max. 500 mL) administered over <15 minutes.
- Group C: Pharmaceutical fresh frozen plasma (OCTAPLAS LG®), bolus dose of 10 mL/kg (max. 500 mL) administered over <15 minutes.
The commercial product OCTAPLAS LG® has been registered with INVIMA in Colombia for five years and is used as a plasma replacement in cardiac surgery, hematologic diseases, or intensive care settings where blood bank plasma is unavailable.
Study Population Children aged 1 month to 18 years diagnosed with sepsis, admitted to the Pediatric Intensive Care Unit (PICU) at Fundación Cardioinfantil over a 12-month period, and meeting eligibility criteria.
- Conditions
- Septic Shock, Pediatric Critical Illness
- Being tested
- Pharmaceutical fresh frozen plasma, Normal Saline, Ringer lactate (RL)
- Keywords
- sepsis, Septic shock, Fluid bolus, plasma, pediatric, crystalloids
- Medical subject headings
- Shock, Septic, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmaceutical fresh frozen plasmaBiological
OCTAPLAS LG® has been registered with INVIMA in Colombia for five years and is used as a plasma replacement in cardiac surgery, hematologic diseases, or intensive care settings where blood bank plasma is unavailable
Normal SalineDrug
Bolus dose of 10 mL/kg normal saline (NS) (max. 500 mL) administered over <15 minutes.
Ringer lactate (RL)Drug
Bolus dose of 10 mL/kg Ringer's lactate (max. 500 mL) administered over <15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| OCTAPLAS LG | Experimental | Pharmaceutical fresh frozen plasma (OCTAPLAS LG®), bolus dose of 10 mL/kg (max. 500 mL) administered over <15 minutes Receives: Biological: Pharmaceutical fresh frozen plasma |
| Normal saline | Active comparator | Bolus dose of 10 mL/kg normal saline (NS) (max. 500 mL) administered over <15 minutes. Receives: Drug: Normal Saline |
| Ringer Lactate | Active comparator | Bolus dose of 10 mL/kg Ringer's lactate (max. 500 mL) administered over <15 minutes. Receives: Drug: Ringer lactate (RL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility in terms of efficacy and safety of crystalloids versus synthetic fresh plasma as the initial resuscitation fluid in children presenting with septic shock: Rate of Signed Informed Consent
Proportion of patients for whom signed informed consent is obtained prior to the intervention.
Measured: Within the first 2 hours after presentation to the PICU. Percentage (%)
Feasibility in terms of efficacy and safety of crystalloids versus synthetic fresh plasma as the initial resuscitation fluid in children presenting with septic shock: Time to Plasma Administration
Time elapsed from clinical indication to administration of the assigned plasma product.
Measured: Within the first 24 hours after admission. Minutes (min)
Feasibility in terms of efficacy and safety of crystalloids versus synthetic fresh plasma as the initial resuscitation fluid in children presenting with septic shock: Follow-up Rate
Proportion of patients with complete follow-up until PICU discharge or day 28, whichever comes first.
Measured: From PICU admission until day 28 or PICU discharge. Percentage (%)
Feasibility in terms of efficacy and safety of crystalloids versus synthetic fresh plasma as the initial resuscitation fluid in children presenting with septic shock: Ability to Obtain and Process Biological Samples
Percentage of biological samples (for clinical laboratory tests, inflammatory markers, and endothelial biomarkers) successfully collected and processed according to protocol.
Measured: During the first 24 hours post-intervention. Percentage (%)
Feasibility in terms of efficacy and safety of crystalloids versus synthetic fresh plasma as the initial resuscitation fluid in children presenting with septic shock: Incidence of Clinical Outcomes
Incidence of clinical outcomes such as mechanical ventilation, inotropic support, multiple organ dysfunction, or mortality.
Measured: Up to 28 days post-intervention or until PICU discharge. Number of events (n), Percentage (%)
Efficacy of crystalloids versus synthetic fresh plasma as the initial resuscitation fluid in children presenting with septic shock in clinical variables and supports: Oxygenation as Assessed by PaO₂/FiO₂ Ratio
Evaluation of oxygenation using the PaO₂/FiO₂ ratio.
Measured: Within the first 24 hours of intervention. Ratio (unitless)
Efficacy of crystalloids versus synthetic fresh plasma as the initial resuscitation fluid in children presenting with septic shock in clinical variables and supports: Oxygenation Index (OI)
Oxygenation Index calculated as (FiO₂ × MAP / PaO₂) × 100.
Measured: Within the first 24 hours of intervention. Unitless value
Efficacy of crystalloids versus synthetic fresh plasma as the initial resuscitation fluid in children presenting with septic shock in clinical variables and supports: Intravascular Volume Status
Assessment of intravascular volume status based on clinical and hemodynamic parameters.
Measured: Within the first 24 hours of intervention. Categorized as improved / no change / worsened (qualitative)
Efficacy of crystalloids versus synthetic fresh plasma as the initial resuscitation fluid in children presenting with septic shock in clinical variables and supports: Inotropic Score
Quantification of cardiovascular support based on standard inotropic scoring systems.
Measured: Maximum value during the first 24 hours post-intervention. Inotropic score (numeric)
Efficacy of crystalloids versus synthetic fresh plasma as the initial resuscitation fluid in children presenting with septic shock in clinical variables and supports: Endothelial Injury Markers
Measurement of circulating endothelial biomarkers such as syndecan-1, angiopoietin-2, or others defined in protocol.
Measured: Baseline and within 24 hours post-intervention. ng/mL
Efficacy of crystalloids versus synthetic fresh plasma as the initial resuscitation fluid in children presenting with septic shock in clinical variables and supports: Hemostatic Measures
Evaluation of coagulation parameters including PT, aPTT, fibrinogen, and D-dimer levels.
Measured: Baseline and within 24 hours post-intervention. Seconds (for PT/aPTT), mg/dL or ng/mL (as applicable)
Efficacy of crystalloids versus synthetic fresh plasma as the initial resuscitation fluid in children presenting with septic shock in clinical variables and supports: Incidence of New or Progressive Organ Failure
Number of patients with new or worsening organ dysfunction during hospitalization.
Measured: Up to 28 days post-intervention or until PICU discharge. Number of patients (n), Percentage (%)
Efficacy of crystalloids versus synthetic fresh plasma as the initial resuscitation fluid in children presenting with septic shock in clinical variables and supports: 28-Day All-Cause Mortality
Death from any cause within 28 days of randomization.
Measured: Up to day 28. Number of deaths (n), Percentage (%)
Efficacy of crystalloids versus synthetic fresh plasma as the initial resuscitation fluid in children presenting with septic shock in clinical variables and supports: Cause of Death
Categorization of causes of death (e.g., refractory shock, respiratory failure, neurologic injury).
Measured: Up to 28 days post-randomization. Categorical (by cause)
Secondary outcomes (19)
Compare hemodynamic parameters using continuous non-invasive cardiac output monitoring (iCON®) between groups: Systemic Vascular Resistance (SVR)
Measurement of systemic vascular resistance using non-invasive cardiac output monitoring (iCON®).
Measured: During the 24-hour intervention period. dyn·s/cm⁵
Compare hemodynamic parameters using continuous non-invasive cardiac output monitoring (iCON®) between groups: Cardiac Output (CO)
Measurement of cardiac output using iCON® monitoring.
Measured: During the 24-hour intervention period. Liters per minute (L/min)
Compare hemodynamic parameters using continuous non-invasive cardiac output monitoring (iCON®) between groups: Cardiac Index (CI)
Measurement of cardiac index using iCON® monitoring.
Measured: During the 24-hour intervention period. Liters per minute per square meter (L/min/m²)
Compare hemodynamic parameters using continuous non-invasive cardiac output monitoring (iCON®) between groups: Stroke Volume Variability (SVV)
Measurement of stroke volume variability using iCON® monitoring.
Measured: During the 24-hour intervention period. Percentage (%)
Compare hemodynamic parameters using continuous non-invasive cardiac output monitoring (iCON®) between groups: Pulse Pressure Variation (PPV)
Measurement of pulse pressure variation using iCON® monitoring.
Measured: During the 24-hour intervention period. Percentage (%)
Total Volume of Resuscitation Fluid Administered Within the First 6, 24, and 48 Hours
Cumulative volume (in milliliters) of the assigned resuscitation fluid (normal saline, lactated Ringer's, or synthetic plasma) administered at three time points: 6 hours, 24 hours, and 48 hours after admission. Volumes will be obtained from the electronic medical records and reported as total volume per patient per time point.
Measured: At 6, 24, and 48 hours after admission. Milliliters (mL)
Evaluate endothelial injury markers and hemostatic parameters, and assess inflammatory markers and coagulation activation measures: Plasma Concentration of IL-1 at 0, 6, and 24 Hours
Quantification of interleukin-1 (IL-1) in plasma at baseline, 6 hours, and 24 hours post-intervention.
Measured: 0, 6, and 24 hours after fluid administration. pg/mL
Evaluate endothelial injury markers and hemostatic parameters, and assess inflammatory markers and coagulation activation measures: Plasma Concentration of IL-6 at 0, 6, and 24 Hours
Quantification of interleukin-6 (IL-6) in plasma at baseline, 6 hours, and 24 hours.
Measured: 0, 6, and 24 hours. pg/mL
Evaluate endothelial injury markers and hemostatic parameters, and assess inflammatory markers and coagulation activation measures: Plasma Concentration of IL-10 at 0, 6, and 24 Hours
Quantification of interleukin-10 (IL-10) in plasma at baseline, 6 hours, and 24 hours.
Measured: 0, 6, and 24 hours. pg/mL
Evaluate endothelial injury markers and hemostatic parameters, and assess inflammatory markers and coagulation activation measures: Plasma Concentration of TNF-alpha at 0, 6, and 24 Hours
Quantification of tumor necrosis factor alpha in plasma at baseline, 6 hours, and 24 hours.
Measured: 0, 6, and 24 hours. pg/mL
Evaluate endothelial injury markers and hemostatic parameters, and assess inflammatory markers and coagulation activation measures: Plasma Concentration of Syndecan-1 at 0, 6, and 24 Hours
Measurement of endothelial injury marker Syndecan-1.
Measured: 0, 6, and 24 hours. ng/mL
Evaluate endothelial injury markers and hemostatic parameters, and assess inflammatory markers and coagulation activation measures: Plasma Concentration of Soluble E-selectin (sE-selectin)
Measurement of soluble E-selectin levels at 0, 6, and 24 hours.
Measured: 0, 6, and 24 hours. ng/mL
Evaluate endothelial injury markers and hemostatic parameters, and assess inflammatory markers and coagulation activation measures: Plasma Concentration of Thrombomodulin
Measurement of thrombomodulin as a marker of endothelial injury.
Measured: 0, 6, and 24 hours. ng/mL
Evaluate endothelial injury markers and hemostatic parameters, and assess inflammatory markers and coagulation activation measures: Plasma Concentration of VEGF and VEGFR-1
Quantification of vascular endothelial growth factor (VEGF) and VEGF receptor 1 (VEGFR1) at baseline and post-intervention.
Measured: 0, 6, and 24 hours. pg/mL
Evaluate endothelial injury markers and hemostatic parameters, and assess inflammatory markers and coagulation activation measures: Plasma Concentration of Coagulation Activation Markers (TAT Complexes, PF-1, PF-2)
Measurement of thrombin-antithrombin complexes (TAT), and platelet factor-1 and -2 (PF-1, PF-2) at specified time points.
Measured: 0, 6, and 24 hours. ng/mL
Safety endpoints, transfusion reactions: Number of Participants with Transfusion-Related Acute Lung Injury (TRALI)
Incidence of TRALI within 24 hours of resuscitation fluid administration, based on clinical criteria (acute lung injury, hypoxemia, and temporal relationship to transfusion).
Measured: Within 24 hours of intervention. Number of participants
Safety endpoints, transfusion reactions: Number of Participants with Transfusion-Associated Circulatory Overload (TACO)
Incidence of TACO based on clinical signs (e.g., hypertension, pulmonary edema, increased BNP, positive fluid balance) within 24 hours post-transfusion.
Measured: Within 24 hours of intervention. Number of participants
Safety endpoints. Transfusion reactions: Number of Participants with Febrile Non-Hemolytic Transfusion Reactions
Number of febrile non-hemolytic transfusion reactions as defined by unexplained fever during or shortly after transfusion.
Measured: Within 24 hours of intervention. Number of participants
Safety endpoints, transfusion reactions: Number of Participants with Allergic Transfusion Reactions
Incidence of allergic reactions (rash, urticaria, pruritus, or anaphylaxis) occurring within 24 hours of transfusion.
Measured: Within 24 hours of intervention. Number of participants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion15 Jul 2026 (estimated)
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients diagnosed with septic shock who meet the inclusion criteria will be randomly assigned to one of three intervention arms: * Group 1: Bolus dose of 10 mL/kg normal saline (NS) (max. 500 mL) administered over \<15 minutes. * Group 2: Bolus dose of 10 mL/kg Ringer's lactate (max. 500 mL) administered over \<15 minutes. * Group 3: Pharmaceutical fresh frozen plasma (OCTAPLAS LG®), bolus dose of 10 mL/kg (max. 500 mL) administered over \<15 minutes.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Cardioinfantil Instituto de Cardiología
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh
- Responsible party
- Sponsor
- Investigators
- Philp Spinella Dr, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07035509
- Sponsor's protocol ID
- CEIC-456-2024
- Acronym
- RESET
- Status last verified
- Jun 2025
- First submitted
- 4 Mar 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Iba T, Maier CL, Helms J, Ferrer R, Thachil J, Levy JH. Managing sepsis and septic shock in an endothelial glycocalyx-friendly way: from the viewpoint of surviving sepsis campaign guidelines. Ann Intensive Care. 2024 Apr 24;14(1):64. doi: 10.1186/s13613-024-01301-6.
PubMed 38658435Obonyo NG, Sela DP, Raman S, Rachakonda R, Schneider B, Hoe LES, Fanning JP, Bassi GL, Maitland K, Suen JY, Fraser JF. Resuscitation-associated endotheliopathy (RAsE): a conceptual framework based on a systematic review and meta-analysis. Syst Rev. 2023 Nov 22;12(1):221. doi: 10.1186/s13643-023-02385-0.
PubMed 37990333Torres LN, Chung KK, Salgado CL, Dubick MA, Torres Filho IP. Low-volume resuscitation with normal saline is associated with microvascular endothelial dysfunction after hemorrhage in rats, compared to colloids and balanced crystalloids. Crit Care. 2017 Jun 29;21(1):160. doi: 10.1186/s13054-017-1745-7.
PubMed 28659186
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Study on Normal Saline vs Plasmalite vs Plasma in REsuscitation of SEpsis Trial (RESET) - A Feasibility and Comparative Study
- ClinicalTrials.gov ID
- NCT07035509
- Acronym / sponsor ID
- RESET / CEIC-456-2024
- Conditions
- Septic Shock, Pediatric Critical Illness
- Keywords
- sepsis, Septic shock, Fluid bolus, plasma, pediatric, crystalloids
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Fundación Cardioinfantil Instituto de CardiologíaUniversity, hospital or other
- Collaborators
- University of Pittsburgh
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 25 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Crystalloids vs. Synthetic Plasma for Fluid Resuscitation in Children with Sepsis - REsuscitation of SEpsis Trial (RESET): A Comparative and Feasibility Study This research study, called the REsuscitation of SEpsis Trial (RESET), is a randomized clinical trial comparing crystalloids and synthetic plasma for fluid resuscitation in children with sepsis. Below, we explain some key aspects you should be aware of.
What is a Clinical Trial? A clinical trial is a type of medical research designed to gather more information on how our bodies respond to medications or other treatments.
Most new medical treatments must be evaluated in clinical trials before they can be approved by government agencies. These agencies ensure that new treatments are not only safe but also beneficial for patients-what medicine refers to as being "safe and effective." If a new treatment has not yet been approved, it is considered "experimental."
Researchers analyze the results of multiple clinical trials to determine which medications work best and how they function. The advancement of medical science requires the participation of many people in numerous studies worldwide.
What is the Purpose of This Study? This study evaluates whether Octaplas LG helps children and adolescents with sepsis and whether it improves the function of blood vessels inflamed due to infection. Sepsis occurs when an infection severely affects a person's health.
Octaplas LG is a medication approved for use in Colombia. It is known as pharmaceutical plasma and is obtained from voluntary donors worldwide. It undergoes an ultra-detailed sterilization process using the most advanced techniques for processing blood derivatives. In medicine, fresh frozen plasma (FFP) is typically used, which is the equivalent of Octaplas LG but with far fewer industrial sterilization processes. These additional processes in Octaplas LG significantly reduce the risk of transmitting infections.
Although Octaplas LG is approved by INVIMA, its use for fluid resuscitation has not yet been approved.
This study will compare Octaplas LG with normal saline solution and Ringer's lactate, which are commonly used for rehydrating patients. All three treatments will be administered in the same manner.
Why is My Child Being Asked to Participate?
Your child is being invited to participate in this clinical study because:
They are receiving care in the pediatric intensive care unit (PICU). They are between one month and 18 years old. They have been diagnosed with sepsis and require fluid resuscitation. Your child's participation is voluntary. If you decide not to participate, your child will not lose any medical benefits. Your child's doctor has determined that they may be a good candidate for this study. You are free to discuss participation with your family, friends, or another physician.
Some members of your child's healthcare team may also be involved in this research. They are dedicated to your child's care as well as the objectives of this study. However, you are not obligated to participate. If you choose to enroll your child, you will be asked to sign an informed consent form.
How Will My Child Be Assigned to a Treatment Group? Upon admission to the pediatric intensive care unit (PICU), if your child has a confirmed sepsis diagnosis and requires intravenous fluids or plasma to support heart function, they will be randomly assigned to one of the three treatment groups.
Randomization is a research method used in clinical trials to assign patients to study groups in an unbiased way-similar to drawing numbers from a hat. Neither you, your child's doctor, nor the researchers will choose which group your child is placed in. Instead, a computer will randomly assign them to a group.
Treatment Groups:
Group 1: Normal Saline (0.9% Sodium Chloride)
Your child will receive the standard treatment for sepsis, including antibiotics, intravenous fluids, heart function monitoring, mechanical ventilation if needed, and blood pressure medications (vasopressors) if necessary.
Group 2: Ringer's Lactate
In addition to standard sepsis management, your child will receive Ringer's lactate, another commonly used resuscitation fluid in pediatric sepsis.
Group 3: Octaplas LG
In addition to standard sepsis management, your child will receive pharmaceutical synthetic plasma, which contains proteins and essential blood components that have undergone advanced processing to eliminate the risk of infectious disease transmission.
How Many Children Will Participate in This Study? At Fundación Cardioinfantil-Instituto de Cardiología, we are seeking the participation of approximately 150 children in this study.
How Long Will My Child Be in the Study? Your child will remain in their assigned treatment group for up to 28 days from PICU admission or until they no longer require intensive care hospitalization.
Detailed description
Protocol Title: Randomized Clinical Trial Comparing Crystalloids vs. Synthetic Plasma for Fluid Resuscitation in Children with Sepsis - REsuscitation of Sepsis Trial (RESET): Feasibility and Comparative Study
Development Phase: Phase IV Study
Sponsor:
Fundación Cardioinfantil - Instituto de Cardiología Children's Hospital of Pittsburgh - Center for Trauma and Transfusion Medicine Research, University of Pittsburgh, Pittsburgh, USA
Medical Sponsor and International Coordinator Dr. Jaime Fernández - Pediatric Intensivist, Head of the Pediatric Intensive Care Unit, Fundación Cardioinfantil, Bogotá, Colombia Dr. Phillip Spinella, MD, FCCM - Pediatric Intensivist, Department of Surgery and Anesthesia, Children's Hospital of Pittsburgh; Emeritus Professor, Department of Surgery and Critical Care, University of Pittsburgh; Director, Center for Trauma and Transfusion Medicine Research, University of Pittsburgh, Pittsburgh, USA
Drug Manufacturer: Octapharma
Study Center: Fundación Cardioinfantil - Bogotá, Colombia
Study Objectives
Primary Objective:
To evaluate the feasibility in terms of efficacy and safety of crystalloids versus synthetic fresh plasma as the initial resuscitation fluid in children presenting with septic shock. Feasibility study.
Secondary Objectives:
- Compare hemodynamic parameters using continuous non-invasive cardiac output monitoring (iCON®) between groups.
- Assess intravascular volume via echocardiography at 6 ± 2, 24 ± 8, and 48 ± 8 hours across groups.
- Compare the total volume of normal saline, lactate, or plasma administered for resuscitation within the first 6, 24, and 48 hours.
- Evaluate net fluid balance at 24 and 48 hours.
- Compare oxygenation parameters (S/F ratio, P/F ratio, oxygenation index) between the two groups at 0, 6, 24, and 48 hours in ventilated children.
- Assess organ dysfunction scores (PELOD, pSOFA, and NP-MODS) daily for 48 hours.
- Compare peak inotropic scores daily over 48 hours.
- Evaluate endothelial injury markers and hemostatic parameters.
- Assess inflammatory markers and coagulation activation measures.
- Monitor transfusion-related reactions.
- Compare healthcare-associated infections.
- Assess 28-day mortality and cause of death.
Study Design A prospective, randomized, open-label, feasibility-controlled trial.
Investigational Medicinal Product
Patients diagnosed with septic shock who meet the inclusion criteria will be randomly assigned to one of three intervention arms:
- Group A: Bolus dose of 10 mL/kg normal saline (NS) (max. 500 mL) administered over <15 minutes.
- Group B: Bolus dose of 10 mL/kg Ringer's lactate (max. 500 mL) administered over <15 minutes.
- Group C: Pharmaceutical fresh frozen plasma (OCTAPLAS LG®), bolus dose of 10 mL/kg (max. 500 mL) administered over <15 minutes.
The commercial product OCTAPLAS LG® has been registered with INVIMA in Colombia for five years and is used as a plasma replacement in cardiac surgery, hematologic diseases, or intensive care settings where blood bank plasma is unavailable.
Study Population Children aged 1 month to 18 years diagnosed with sepsis, admitted to the Pediatric Intensive Care Unit (PICU) at Fundación Cardioinfantil over a 12-month period, and meeting eligibility criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Patients diagnosed with septic shock who meet the inclusion criteria will be randomly assigned to one of three intervention arms: * Group 1: Bolus dose of 10 mL/kg normal saline (NS) (max. 500 mL) administered over <15 minutes. * Group 2: Bolus dose of 10 mL/kg Ringer's lactate (max. 500 mL) administered over <15 minutes. * Group 3: Pharmaceutical fresh frozen plasma (OCTAPLAS LG®), bolus dose of 10 mL/kg (max. 500 mL) administered over <15 minutes.
| Arm | Type | Receives |
|---|---|---|
| OCTAPLAS LG | Experimental | Biological: Pharmaceutical fresh frozen plasmaPharmaceutical fresh frozen plasma (OCTAPLAS LG®), bolus dose of 10 mL/kg (max. 500 mL) administered over <15 minutes |
| Normal saline | Active comparator | Drug: Normal SalineBolus dose of 10 mL/kg normal saline (NS) (max. 500 mL) administered over <15 minutes. |
| Ringer Lactate | Active comparator | Drug: Ringer lactate (RL)Bolus dose of 10 mL/kg Ringer's lactate (max. 500 mL) administered over <15 minutes. |
Who may qualify
- Ages
- 4 weeks to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age: ≥1 month (corrected gestational age) to 18 years.
- Diagnosis of sepsis with at least one of the following conditions:
- Signs of poor perfusion: prolonged capillary refill ≥2 sec, weak peripheral pulses, unexplained metabolic acidosis (base deficit > (-)5.0 mEq/L), altered. mental status, lactate ≥2 mmol/L (sample drawn without tourniquet use. (Appendix 2). OR
- Systolic blood pressure (SBP) below the 5th percentile for age.
- Signed informed consent from the patient's legal guardian.
Key exclusion criteria (7 listed)
- Receipt of ≥2 boluses of NS 0.9% or balanced solution in the last 24 hours for the current sepsis episode (bolus defined as ≥10 mL/kg (max. 500 mL) of NS/RL given in <30 min).
- Known allergic reaction to plasma-derived products.
- Known IgA deficiency.
- Suspected or confirmed congestive heart failure.
- Nephrotic syndrome.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmaceutical fresh frozen plasmaOCTAPLAS LG® has been registered with INVIMA in Colombia for five years and is used as a plasma replacement in cardiac surgery, hematologic diseases, or intensive care settings where blood bank plasma is unavailable | Biological | OCTAPLAS LG |
| Normal SalineBolus dose of 10 mL/kg normal saline (NS) (max. 500 mL) administered over <15 minutes. | Drug | Normal saline |
| Ringer lactate (RL)Bolus dose of 10 mL/kg Ringer's lactate (max. 500 mL) administered over <15 minutes. | Drug | Ringer Lactate |
Primary outcome
Feasibility in terms of efficacy and safety of crystalloids versus synthetic fresh plasma as the initial resuscitation fluid in children presenting with septic shock: Rate of Signed Informed Consent
Time frame: Within the first 2 hours after presentation to the PICU. Percentage (%)
Proportion of patients for whom signed informed consent is obtained prior to the intervention.
Feasibility in terms of efficacy and safety of crystalloids versus synthetic fresh plasma as the initial resuscitation fluid in children presenting with septic shock: Time to Plasma Administration
Time frame: Within the first 24 hours after admission. Minutes (min)
Time elapsed from clinical indication to administration of the assigned plasma product.
Feasibility in terms of efficacy and safety of crystalloids versus synthetic fresh plasma as the initial resuscitation fluid in children presenting with septic shock: Follow-up Rate
Time frame: From PICU admission until day 28 or PICU discharge. Percentage (%)
Proportion of patients with complete follow-up until PICU discharge or day 28, whichever comes first.
Feasibility in terms of efficacy and safety of crystalloids versus synthetic fresh plasma as the initial resuscitation fluid in children presenting with septic shock: Ability to Obtain and Process Biological Samples
Time frame: During the first 24 hours post-intervention. Percentage (%)
Percentage of biological samples (for clinical laboratory tests, inflammatory markers, and endothelial biomarkers) successfully collected and processed according to protocol.
Feasibility in terms of efficacy and safety of crystalloids versus synthetic fresh plasma as the initial resuscitation fluid in children presenting with septic shock: Incidence of Clinical Outcomes
Time frame: Up to 28 days post-intervention or until PICU discharge. Number of events (n), Percentage (%)
Incidence of clinical outcomes such as mechanical ventilation, inotropic support, multiple organ dysfunction, or mortality.
Efficacy of crystalloids versus synthetic fresh plasma as the initial resuscitation fluid in children presenting with septic shock in clinical variables and supports: Oxygenation as Assessed by PaO₂/FiO₂ Ratio
Time frame: Within the first 24 hours of intervention. Ratio (unitless)
Evaluation of oxygenation using the PaO₂/FiO₂ ratio.
Efficacy of crystalloids versus synthetic fresh plasma as the initial resuscitation fluid in children presenting with septic shock in clinical variables and supports: Oxygenation Index (OI)
Time frame: Within the first 24 hours of intervention. Unitless value
Oxygenation Index calculated as (FiO₂ × MAP / PaO₂) × 100.
Efficacy of crystalloids versus synthetic fresh plasma as the initial resuscitation fluid in children presenting with septic shock in clinical variables and supports: Intravascular Volume Status
Time frame: Within the first 24 hours of intervention. Categorized as improved / no change / worsened (qualitative)
Assessment of intravascular volume status based on clinical and hemodynamic parameters.
Efficacy of crystalloids versus synthetic fresh plasma as the initial resuscitation fluid in children presenting with septic shock in clinical variables and supports: Inotropic Score
Time frame: Maximum value during the first 24 hours post-intervention. Inotropic score (numeric)
Quantification of cardiovascular support based on standard inotropic scoring systems.
Efficacy of crystalloids versus synthetic fresh plasma as the initial resuscitation fluid in children presenting with septic shock in clinical variables and supports: Endothelial Injury Markers
Time frame: Baseline and within 24 hours post-intervention. ng/mL
Measurement of circulating endothelial biomarkers such as syndecan-1, angiopoietin-2, or others defined in protocol.
Efficacy of crystalloids versus synthetic fresh plasma as the initial resuscitation fluid in children presenting with septic shock in clinical variables and supports: Hemostatic Measures
Time frame: Baseline and within 24 hours post-intervention. Seconds (for PT/aPTT), mg/dL or ng/mL (as applicable)
Evaluation of coagulation parameters including PT, aPTT, fibrinogen, and D-dimer levels.
Efficacy of crystalloids versus synthetic fresh plasma as the initial resuscitation fluid in children presenting with septic shock in clinical variables and supports: Incidence of New or Progressive Organ Failure
Time frame: Up to 28 days post-intervention or until PICU discharge. Number of patients (n), Percentage (%)
Number of patients with new or worsening organ dysfunction during hospitalization.
Efficacy of crystalloids versus synthetic fresh plasma as the initial resuscitation fluid in children presenting with septic shock in clinical variables and supports: 28-Day All-Cause Mortality
Time frame: Up to day 28. Number of deaths (n), Percentage (%)
Death from any cause within 28 days of randomization.
Efficacy of crystalloids versus synthetic fresh plasma as the initial resuscitation fluid in children presenting with septic shock in clinical variables and supports: Cause of Death
Time frame: Up to 28 days post-randomization. Categorical (by cause)
Categorization of causes of death (e.g., refractory shock, respiratory failure, neurologic injury).
19 secondary outcomes
Compare hemodynamic parameters using continuous non-invasive cardiac output monitoring (iCON®) between groups: Systemic Vascular Resistance (SVR)
Time frame: During the 24-hour intervention period. dyn·s/cm⁵
Compare hemodynamic parameters using continuous non-invasive cardiac output monitoring (iCON®) between groups: Cardiac Output (CO)
Time frame: During the 24-hour intervention period. Liters per minute (L/min)
Compare hemodynamic parameters using continuous non-invasive cardiac output monitoring (iCON®) between groups: Cardiac Index (CI)
Time frame: During the 24-hour intervention period. Liters per minute per square meter (L/min/m²)
Compare hemodynamic parameters using continuous non-invasive cardiac output monitoring (iCON®) between groups: Stroke Volume Variability (SVV)
Time frame: During the 24-hour intervention period. Percentage (%)
Compare hemodynamic parameters using continuous non-invasive cardiac output monitoring (iCON®) between groups: Pulse Pressure Variation (PPV)
Time frame: During the 24-hour intervention period. Percentage (%)
Total Volume of Resuscitation Fluid Administered Within the First 6, 24, and 48 Hours
Time frame: At 6, 24, and 48 hours after admission. Milliliters (mL)
Evaluate endothelial injury markers and hemostatic parameters, and assess inflammatory markers and coagulation activation measures: Plasma Concentration of IL-1 at 0, 6, and 24 Hours
Time frame: 0, 6, and 24 hours after fluid administration. pg/mL
Evaluate endothelial injury markers and hemostatic parameters, and assess inflammatory markers and coagulation activation measures: Plasma Concentration of IL-6 at 0, 6, and 24 Hours
Time frame: 0, 6, and 24 hours. pg/mL
Evaluate endothelial injury markers and hemostatic parameters, and assess inflammatory markers and coagulation activation measures: Plasma Concentration of IL-10 at 0, 6, and 24 Hours
Time frame: 0, 6, and 24 hours. pg/mL
Evaluate endothelial injury markers and hemostatic parameters, and assess inflammatory markers and coagulation activation measures: Plasma Concentration of TNF-alpha at 0, 6, and 24 Hours
Time frame: 0, 6, and 24 hours. pg/mL
Evaluate endothelial injury markers and hemostatic parameters, and assess inflammatory markers and coagulation activation measures: Plasma Concentration of Syndecan-1 at 0, 6, and 24 Hours
Time frame: 0, 6, and 24 hours. ng/mL
Evaluate endothelial injury markers and hemostatic parameters, and assess inflammatory markers and coagulation activation measures: Plasma Concentration of Soluble E-selectin (sE-selectin)
Time frame: 0, 6, and 24 hours. ng/mL
Evaluate endothelial injury markers and hemostatic parameters, and assess inflammatory markers and coagulation activation measures: Plasma Concentration of Thrombomodulin
Time frame: 0, 6, and 24 hours. ng/mL
Evaluate endothelial injury markers and hemostatic parameters, and assess inflammatory markers and coagulation activation measures: Plasma Concentration of VEGF and VEGFR-1
Time frame: 0, 6, and 24 hours. pg/mL
Evaluate endothelial injury markers and hemostatic parameters, and assess inflammatory markers and coagulation activation measures: Plasma Concentration of Coagulation Activation Markers (TAT Complexes, PF-1, PF-2)
Time frame: 0, 6, and 24 hours. ng/mL
Safety endpoints, transfusion reactions: Number of Participants with Transfusion-Related Acute Lung Injury (TRALI)
Time frame: Within 24 hours of intervention. Number of participants
Safety endpoints, transfusion reactions: Number of Participants with Transfusion-Associated Circulatory Overload (TACO)
Time frame: Within 24 hours of intervention. Number of participants
Safety endpoints. Transfusion reactions: Number of Participants with Febrile Non-Hemolytic Transfusion Reactions
Time frame: Within 24 hours of intervention. Number of participants
Safety endpoints, transfusion reactions: Number of Participants with Allergic Transfusion Reactions
Time frame: Within 24 hours of intervention. Number of participants
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Results publication: PubMed 38658435Iba T, Maier CL, Helms J, Ferrer R, Thachil J, Levy JH. Managing sepsis and septic shock in an endothelial glycocalyx-friendly way: from the viewpoint of surviving sepsis campaign guidelines. Ann Intensive Care. 2024 Apr 24;14(1):64. doi: 10.1186/s13613-024-01301-6.
- Results publication: PubMed 37990333Obonyo NG, Sela DP, Raman S, Rachakonda R, Schneider B, Hoe LES, Fanning JP, Bassi GL, Maitland K, Suen JY, Fraser JF. Resuscitation-associated endotheliopathy (RAsE): a conceptual framework based on a systematic review and meta-analysis. Syst Rev. 2023 Nov 22;12(1):221. doi: 10.1186/s13643-023-02385-0.
- Results publication: PubMed 28659186Torres LN, Chung KK, Salgado CL, Dubick MA, Torres Filho IP. Low-volume resuscitation with normal saline is associated with microvascular endothelial dysfunction after hemorrhage in rats, compared to colloids and balanced crystalloids. Crit Care. 2017 Jun 29;21(1):160. doi: 10.1186/s13054-017-1745-7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Philp Spinella Dr, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pharmaceutical fresh frozen plasma, Normal Saline and Ringer lactate (RL) in people with Septic Shock and Pediatric Critical Illness, run by Fundación Cardioinfantil Instituto de Cardiología at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jaime Fernandez Dr, PHD (+576016672727 ext. 73210, jfernandez@lacardio.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility in terms of efficacy and safety of crystalloids versus synthetic fresh plasma as the initial resuscitation fluid in children presenting with septic shock: Rate of Signed Informed Consent (time frame: Within the first 2 hours after presentation to the PICU. Percentage (%)). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07035509, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.