Fluid and Electrolyte ImbalanceNCT06499701
Volume Kinetics of Fluid Resuscitation in Early Sepsis
An observational study of Fluid and Electrolyte Imbalance, run by Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu at 2 sites in Romania.
Trial summary
The recommended volume resuscitation for patients with early sepsis-induced hypoperfusion is at least 30 ml/kg of crystalloid administered within the first three hours. However, this standardized approach does not account for individual patient variability and lacks personalization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fluid and Electrolyte Imbalance
- What is being tested?
- Ringer's Lactate
- Type of treatment
- Injection or infusion
- How many people
- 13 participants
- Where
- 2 sitesRomania
- Study dates
- 19 Jun 2024to 1 Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients admitted in the intensive care unit (ICU) with sepsis, as defined by the Sepsis-3 criteria and exhibiting sepsis-induced hypoperfusion prior to the administration of adequate volume resuscitation.
Who may be able to join
- A diagnosis of sepsis, as defined by the Sepsis-3 criteria and exhibiting sepsis-induced hypoperfusion prior to the administration of adequate volume resuscitation:
- hypotension requiring norepinephrine to maintain a mean arterial blood pressure (MAP) either predefined by the clinician or at 65 mm Hg or higher and/or
- a serum lactate level >2 mmol/L (18mg/dL) and/or
- acute oliguria defined as urine output <0.5mL/kg/hr and/or
- mottled skin and/or
- capillary refill time > 3 seconds.
Who cannot join
- Administration of at least 1 L of IV fluid in the last 6 hours prior to screening. All crystalloids, colloids and blood products that the patient has received are counted.
- Known pregnancy.
- Competing causes of lactic acidosis including: seizures within 3 hours of enrollment, use of linezolid or metformin or anti-retrovirals at the time of enrollment, carbon monoxide or cyanide poisoning, highly suspected or known ischemic bowel, and known mitochondrial disorders.
- End-stage renal disease that requires chronic dialysis.
- Concurrent haemorrhagic or obstructive shock.
- Increased risk of fluid intolerance:
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- Echocardiographic evidence of moderate or severe left ventricular systolic dysfunction.
- Echocardiographic evidence of moderate or severe right ventricular systolic dysfunction.
- Hypoxemia index < 200 mmHg or sonographic evidence of bilateral B or C profile.
- Abdominal compartment syndrome.
- Post-cardiac arrest.
Trial locations and contacts
2 sites in 1 country.
Romania2 sites
Fundeni Clinical Institute
Bucharest, Bucharest, 022328
"Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases
Bucharest, 022328
About this study
Official title: Volume Kinetics of Fluid Resuscitation With 30 ml/kg Ringer Lactate in Early Sepsis
The recommended volume resuscitation for patients with early sepsis-induced hypoperfusion is at least 30 ml/kg of crystalloid administered within the first three hours. However, this standardized approach does not account for individual patient variability and lacks personalization. Additionally, the effects of administering 30 ml/kg on intercompartmental fluid shifts between the plasma and interstitial compartments remain unclear. This study aims to describe the volume kinetics of administering 30 ml/kg of Ringer's Lactate in patients with early sepsis-induced hypoperfusion within the first three hours.
Read the detailed description
Adult patients admitted to the intensive care unit (ICU) with sepsis, as defined by the Sepsis-3 criteria, and exhibiting sepsis-induced hypoperfusion prior to receiving adequate volume resuscitation (i.e., 30 ml/kg of crystalloid), are administered Ringer's Lactate at a dose of 30 ml/kg. The initial 20 ml/kg is infused at a constant rate over the first 30 minutes, followed by a 30-minute pause, with an additional 10 ml/kg administered over the subsequent 15 minutes, completing the infusion within 75 minutes.
Up to 180 minutes post-infusion, no other fluids (e.g., gelatin, albumin) are administered except for antibiotics, sedatives, or vasoactive substances as needed. Ideally, only one catecholamine (e.g., norepinephrine) is administered. The volume and quantity of these substances are recorded. Arterial blood samples are collected for blood gas analysis, including hemoglobin levels. Urinary output is measured at 30, 60, and 180 minutes, and any blood loss, other than the 1.5 ml per sample collected, is quantified during hemoglobin monitoring. Additionally, urinary creatinine concentration is determined from urine samples collected at baseline.
The hemodilution data are utilized as input into a three-compartment model with microconstants for fluid redistribution and excretion.
- Conditions
- Fluid and Electrolyte Imbalance
- Being tested
- Ringer's Lactate
- Keywords
- volume kinetics, sepsis, volume resuscitation, crystalloid, Ringer's Lactate
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ringer's LactateDrug
Also called Crystalloid
Ringer's Lactate is administered at a dose of 30ml/kg, with the first 20ml/kg given at a constant rate over the initial 30 minutes, followed by a 30-minute pause, and then an additional 10ml/kg over the next 15 minutes, completing the infusion within 75 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Ringer's Lactate | Adult patients admitted in the intensive care unit (ICU) with sepsis, as defined by the Sepsis-3 criteria and exhibiting sepsis-induced hypoperfusion prior to the administration of adequate volume resuscitation (i.e., 30 ml/kg crystalloid). Receives: Drug: Ringer's Lactate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Volume
Plasma volume (ml) was determined using a three-compartment kinetic model with five rate constants (k12, k21, k23, k32 and k10) and a scaling factor (Vc, central volume) that relates dilution to volume. This model was applied to the dependent variables, which included frequently measured plasma dilution and urinary excretion.
Measured: 180 minutes after the start of the Ringer's Lactate infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start19 Jun 2024
- Primary completion1 Sep 2026
- Study completion1 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid and Electrolyte ImbalanceStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Balan Ion Cosmin, Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu
- Investigators
- Robert Hahn, Professor, Study chair, Karolinska Institutet: Stockholm, SE (Department of Clinical Sciences, Danderyd Hospital) EmploymentSerban-Ion Bubenek-Turconi, Professor, Study director, "Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06499701
- Sponsor's protocol ID
- 17736
- Status last verified
- Oct 2026
- First submitted
- 7 Jul 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volume Kinetics of Fluid Resuscitation With 30 ml/kg Ringer Lactate in Early Sepsis
- ClinicalTrials.gov ID
- NCT06499701
- Acronym / sponsor ID
- 17736
- Conditions
- Fluid and Electrolyte Imbalance
- Keywords
- volume kinetics, sepsis, volume resuscitation, crystalloid, Ringer's Lactate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. IliescuUniversity, hospital or other
- Study start
- 19 Jun 2024 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 1 Oct 2026 (actual)
- First posted
- 12 Jul 2024 (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.
The recommended volume resuscitation for patients with early sepsis-induced hypoperfusion is at least 30 ml/kg of crystalloid administered within the first three hours. However, this standardized approach does not account for individual patient variability and lacks personalization. Additionally, the effects of administering 30 ml/kg on intercompartmental fluid shifts between the plasma and interstitial compartments remain unclear. This study aims to describe the volume kinetics of administering 30 ml/kg of Ringer's Lactate in patients with early sepsis-induced hypoperfusion within the first three hours.
Detailed description
Adult patients admitted to the intensive care unit (ICU) with sepsis, as defined by the Sepsis-3 criteria, and exhibiting sepsis-induced hypoperfusion prior to receiving adequate volume resuscitation (i.e., 30 ml/kg of crystalloid), are administered Ringer's Lactate at a dose of 30 ml/kg. The initial 20 ml/kg is infused at a constant rate over the first 30 minutes, followed by a 30-minute pause, with an additional 10 ml/kg administered over the subsequent 15 minutes, completing the infusion within 75 minutes.
Up to 180 minutes post-infusion, no other fluids (e.g., gelatin, albumin) are administered except for antibiotics, sedatives, or vasoactive substances as needed. Ideally, only one catecholamine (e.g., norepinephrine) is administered. The volume and quantity of these substances are recorded. Arterial blood samples are collected for blood gas analysis, including hemoglobin levels. Urinary output is measured at 30, 60, and 180 minutes, and any blood loss, other than the 1.5 ml per sample collected, is quantified during hemoglobin monitoring. Additionally, urinary creatinine concentration is determined from urine samples collected at baseline.
The hemodilution data are utilized as input into a three-compartment model with microconstants for fluid redistribution and excretion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ringer's Lactate | – | Drug: Ringer's LactateAdult patients admitted in the intensive care unit (ICU) with sepsis, as defined by the Sepsis-3 criteria and exhibiting sepsis-induced hypoperfusion prior to the administration of adequate volume resuscitation (i.e., 30 ml/kg crystalloid). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted in the intensive care unit (ICU) with sepsis, as defined by the Sepsis-3 criteria and exhibiting sepsis-induced hypoperfusion prior to the administration of adequate volume resuscitation.
Key inclusion criteria (6 listed)
- A diagnosis of sepsis, as defined by the Sepsis-3 criteria and exhibiting sepsis-induced hypoperfusion prior to the administration of adequate volume resuscitation:
- hypotension requiring norepinephrine to maintain a mean arterial blood pressure (MAP) either predefined by the clinician or at 65 mm Hg or higher and/or
- a serum lactate level >2 mmol/L (18mg/dL) and/or
- acute oliguria defined as urine output <0.5mL/kg/hr and/or
- mottled skin and/or
Key exclusion criteria (11 listed)
- Administration of at least 1 L of IV fluid in the last 6 hours prior to screening. All crystalloids, colloids and blood products that the patient has received are counted.
- Known pregnancy.
- Competing causes of lactic acidosis including: seizures within 3 hours of enrollment, use of linezolid or metformin or anti-retrovirals at the time of enrollment, carbon monoxide or cyanide poisoning, highly suspected or known ischemic bowel, and known mitochondrial disorders.
- End-stage renal disease that requires chronic dialysis.
- Concurrent haemorrhagic or obstructive shock.
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 |
|---|---|---|
| Ringer's LactateAlso: CrystalloidRinger's Lactate is administered at a dose of 30ml/kg, with the first 20ml/kg given at a constant rate over the initial 30 minutes, followed by a 30-minute pause, and then an additional 10ml/kg over the next 15 minutes, completing the infusion within 75 minutes. | Drug | Ringer's Lactate |
Primary outcome
Plasma Volume
Time frame: 180 minutes after the start of the Ringer's Lactate infusion
Plasma volume (ml) was determined using a three-compartment kinetic model with five rate constants (k12, k21, k23, k32 and k10) and a scaling factor (Vc, central volume) that relates dilution to volume. This model was applied to the dependent variables, which included frequently measured plasma dilution and urinary excretion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
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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. This study is not recruiting at the moment.
Robert Hahn, Professor study chair
Karolinska Institutet: Stockholm, SE (Department of Clinical Sciences, Danderyd Hospital) Employment
Serban-Ion Bubenek-Turconi, Professor study director
"Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fluid and Electrolyte Imbalance, run by Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu at 2 sites in Romania.
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 6 inclusion and 11 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: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Romania. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Volume (time frame: 180 minutes after the start of the Ringer's Lactate infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Oct 2026.