Septic ShockNCT07418541
Early Co-Administration of Crystalloid Fluid and Norepinephrine for Preventing Acute Kidney Injury in Septic Shock
A study testing Norepinephrine and Crystalloid Fluid Resuscitation in people with Septic Shock and Acute Kidney Injury, run by Universitas Sumatera Utara.
Trial summary
Septic shock is a life-threatening condition that can cause severe circulatory failure and damage to vital organs, including the kidneys. One of the most serious complications of septic shock is acute kidney injury (AKI), which is associated with increased morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Acute Kidney Injury
- What is being tested?
- Norepinephrine and Crystalloid Fluid Resuscitation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 23 Apr 2026to Dec 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 18 years or older.
- Diagnosed with septic shock based on clinical criteria.
- Require fluid resuscitation and vasopressor support.
- Admitted to the intensive care unit or emergency department.
- Have complete baseline clinical and hemodynamic data.
Who cannot join
- Patients with end-stage renal disease or receiving chronic dialysis.
- Known pregnancy.
- History of severe chronic kidney disease.
- Patients with limitations of care or do-not-resuscitate orders.
- Incomplete clinical data for outcome assessment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Early Co-Administration of 30 mL/kg Crystalloid Fluid and Norepinephrine for Preventing Acute Kidney Injury in Septic Shock: A Pretest-Posttest Clinical Study
Septic shock is a life-threatening condition that can cause severe circulatory failure and damage to vital organs, including the kidneys. One of the most serious complications of septic shock is acute kidney injury (AKI), which is associated with increased morbidity and mortality.
This study aims to evaluate the effect of early co-administration of crystalloid fluid resuscitation (30 mL/kg body weight) and norepinephrine on preventing acute kidney injury and improving hemodynamic stability in adult patients with septic shock. Patients will receive standard initial fluid resuscitation combined with early norepinephrine infusion according to a predefined clinical protocol.
Changes in blood pressure, urine output, and other hemodynamic parameters will be observed before and after the intervention. The findings of this study are expected to provide evidence to support early hemodynamic optimization strategies for reducing the risk of acute kidney injury in septic shock patients.
Read the detailed description
This study is a pretest-posttest interventional clinical study designed to evaluate the effectiveness of early co-administration of crystalloid fluid resuscitation and norepinephrine in patients with septic shock. Septic shock is characterized by persistent hypotension requiring vasopressor therapy despite adequate fluid resuscitation and is associated with a high risk of acute kidney injury.
Eligible participants are adult patients diagnosed with septic shock who meet the study inclusion criteria. All participants will receive crystalloid fluid resuscitation at a dose of 30 mL/kg body weight, followed by early initiation of norepinephrine infusion at an initial dose of approximately 0.05 µg/kg/min, titrated according to hemodynamic response and clinical judgment.
Hemodynamic parameters, including mean arterial pressure, heart rate, oxygen saturation, urine output, and central venous pressure (when available), will be measured before and after the intervention. Renal function indicators will be monitored to assess the occurrence of early acute kidney injury.
The primary objective of this study is to evaluate the effect of early combined fluid resuscitation and norepinephrine administration on the prevention of acute kidney injury. Secondary objectives include assessment of changes in hemodynamic stability following the intervention. The results of this study are expected to contribute to evidence-based management strategies for septic shock in resource-limited clinical settings.
- Conditions
- Septic Shock, Acute Kidney Injury
- Being tested
- Norepinephrine, Crystalloid Fluid Resuscitation
- Keywords
- Sepsis, Fluid Resuscitation, Norepinephrine, Hemodynamic Stabilization, Acute Kidney Injury Prevention
- Medical subject headings
- Shock, Septic, Acute Kidney Injury, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NorepinephrineDrug
Also called Noradrenaline
Norepinephrine is administered as an intravenous infusion initiated early in patients with septic shock at an initial dose of approximately 0.05 µg/kg/min. The dose is titrated based on hemodynamic response to achieve and maintain adequate mean arterial pressure in accordance with standard clinical practice.
Crystalloid Fluid ResuscitationOther
Also called Intravenous Crystalloid Fluids
Participants receive intravenous crystalloid fluid resuscitation at a total dose of 30 mL per kilogram of body weight as part of early management of septic shock. Fluid administration is provided according to institutional protocols and patient clinical condition.
| Study group | Role | What they receive |
|---|---|---|
| Early Fluid Resuscitation Plus Norepinephrine | Experimental | Participants in this single study arm receive early crystalloid fluid resuscitation at a dose of 30 mL/kg body weight combined with early initiation of norepinephrine infusion. Norepinephrine is started at an initial dose of approximately 0.05 µg/kg/min and titrated according to hemodynamic response to achieve adequate mean arterial pressure. Hemodynamic and renal parameters are assessed before and after the intervention. Receives: Drug: Norepinephrine; Other: Crystalloid Fluid Resuscitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Acute Kidney Injury
Acute kidney injury is assessed based on changes in renal function parameters following early co-administration of crystalloid fluid resuscitation and norepinephrine in patients with septic shock.
Measured: Within 48 hours after intervention
Secondary outcomes (1)
Change in Mean Arterial Pressure
Change in mean arterial pressure measured before and after administration of crystalloid fluid and norepinephrine.
Measured: Within 30 minutes after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start23 Apr 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study uses a single-group pretest-posttest design in which all participants receive early co-administration of crystalloid fluid resuscitation and norepinephrine. Hemodynamic and renal parameters are assessed before and after the intervention.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Sumatera Utara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irfan Julio Nasution, Universitas Sumatera Utara
- Investigators
- Irfan Julio Nasution, MD, Principal investigator, Universitas Sumatera Utara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07418541
- Sponsor's protocol ID
- 344/KEPK/USU/2025
- Other IDs
- No.344/KEPK/USU/2025
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mehta Y, Paul R, Rabbani R, Acharya SP, Withanaarachchi UK. Sepsis Management in Southeast Asia: A Review and Clinical Experience. J Clin Med. 2022 Jun 23;11(13):3635. doi: 10.3390/jcm11133635.
PubMed 35806919Monnet X, Lai C, Ospina-Tascon G, De Backer D. Evidence for a personalized early start of norepinephrine in septic shock. Crit Care. 2023 Aug 22;27(1):322. doi: 10.1186/s13054-023-04593-5.
PubMed 37608327Ospina-Tascon GA, Hernandez G, Alvarez I, Calderon-Tapia LE, Manzano-Nunez R, Sanchez-Ortiz AI, Quinones E, Ruiz-Yucuma JE, Aldana JL, Teboul JL, Cavalcanti AB, De Backer D, Bakker J. Effects of very early start of norepinephrine in patients with septic shock: a propensity score-based analysis. Crit Care. 2020 Feb 14;24(1):52. doi: 10.1186/s13054-020-2756-3.
PubMed 32059682Permpikul C, Tongyoo S, Viarasilpa T, Trainarongsakul T, Chakorn T, Udompanturak S. Early Use of Norepinephrine in Septic Shock Resuscitation (CENSER). A Randomized Trial. Am J Respir Crit Care Med. 2019 May 1;199(9):1097-1105. doi: 10.1164/rccm.201806-1034OC.
PubMed 30704260
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Co-Administration of 30 mL/kg Crystalloid Fluid and Norepinephrine for Preventing Acute Kidney Injury in Septic Shock: A Pretest-Posttest Clinical Study
- ClinicalTrials.gov ID
- NCT07418541
- Acronym / sponsor ID
- 344/KEPK/USU/2025
- Conditions
- Septic Shock, Acute Kidney Injury
- Keywords
- Sepsis, Fluid Resuscitation, Norepinephrine, Hemodynamic Stabilization, Acute Kidney Injury Prevention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universitas Sumatera UtaraUniversity, hospital or other
- Study start
- 23 Apr 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Feb 2026 (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.
Septic shock is a life-threatening condition that can cause severe circulatory failure and damage to vital organs, including the kidneys. One of the most serious complications of septic shock is acute kidney injury (AKI), which is associated with increased morbidity and mortality.
This study aims to evaluate the effect of early co-administration of crystalloid fluid resuscitation (30 mL/kg body weight) and norepinephrine on preventing acute kidney injury and improving hemodynamic stability in adult patients with septic shock. Patients will receive standard initial fluid resuscitation combined with early norepinephrine infusion according to a predefined clinical protocol.
Changes in blood pressure, urine output, and other hemodynamic parameters will be observed before and after the intervention. The findings of this study are expected to provide evidence to support early hemodynamic optimization strategies for reducing the risk of acute kidney injury in septic shock patients.
Detailed description
This study is a pretest-posttest interventional clinical study designed to evaluate the effectiveness of early co-administration of crystalloid fluid resuscitation and norepinephrine in patients with septic shock. Septic shock is characterized by persistent hypotension requiring vasopressor therapy despite adequate fluid resuscitation and is associated with a high risk of acute kidney injury.
Eligible participants are adult patients diagnosed with septic shock who meet the study inclusion criteria. All participants will receive crystalloid fluid resuscitation at a dose of 30 mL/kg body weight, followed by early initiation of norepinephrine infusion at an initial dose of approximately 0.05 µg/kg/min, titrated according to hemodynamic response and clinical judgment.
Hemodynamic parameters, including mean arterial pressure, heart rate, oxygen saturation, urine output, and central venous pressure (when available), will be measured before and after the intervention. Renal function indicators will be monitored to assess the occurrence of early acute kidney injury.
The primary objective of this study is to evaluate the effect of early combined fluid resuscitation and norepinephrine administration on the prevention of acute kidney injury. Secondary objectives include assessment of changes in hemodynamic stability following the intervention. The results of this study are expected to contribute to evidence-based management strategies for septic shock in resource-limited clinical settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study uses a single-group pretest-posttest design in which all participants receive early co-administration of crystalloid fluid resuscitation and norepinephrine. Hemodynamic and renal parameters are assessed before and after the intervention.
| Arm | Type | Receives |
|---|---|---|
| Early Fluid Resuscitation Plus Norepinephrine | Experimental | Drug: Norepinephrine, Other: Crystalloid Fluid ResuscitationParticipants in this single study arm receive early crystalloid fluid resuscitation at a dose of 30 mL/kg body weight combined with early initiation of norepinephrine infusion. Norepinephrine is started at an initial dose of approximately 0.05 µg/kg/min and titrated according to hemodynamic response to achieve adequate mean arterial pressure. Hemodynamic and renal parameters are assessed before and after the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients aged 18 years or older.
- Diagnosed with septic shock based on clinical criteria.
- Require fluid resuscitation and vasopressor support.
- Admitted to the intensive care unit or emergency department.
- Have complete baseline clinical and hemodynamic data.
Key exclusion criteria (5 listed)
- Patients with end-stage renal disease or receiving chronic dialysis.
- Known pregnancy.
- History of severe chronic kidney disease.
- Patients with limitations of care or do-not-resuscitate orders.
- Incomplete clinical data for outcome assessment.
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 |
|---|---|---|
| NorepinephrineAlso: NoradrenalineNorepinephrine is administered as an intravenous infusion initiated early in patients with septic shock at an initial dose of approximately 0.05 µg/kg/min. The dose is titrated based on hemodynamic response to achieve and maintain adequate mean arterial pressure in accordance with standard clinical practice. | Drug | Early Fluid Resuscitation Plus Norepinephrine |
| Crystalloid Fluid ResuscitationAlso: Intravenous Crystalloid FluidsParticipants receive intravenous crystalloid fluid resuscitation at a total dose of 30 mL per kilogram of body weight as part of early management of septic shock. Fluid administration is provided according to institutional protocols and patient clinical condition. | Other | Early Fluid Resuscitation Plus Norepinephrine |
Primary outcome
Occurrence of Acute Kidney Injury
Time frame: Within 48 hours after intervention
Acute kidney injury is assessed based on changes in renal function parameters following early co-administration of crystalloid fluid resuscitation and norepinephrine in patients with septic shock.
1 secondary outcome
Change in Mean Arterial Pressure
Time frame: Within 30 minutes after intervention
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 18 Feb 2026.
- Background: PubMed 35806919Mehta Y, Paul R, Rabbani R, Acharya SP, Withanaarachchi UK. Sepsis Management in Southeast Asia: A Review and Clinical Experience. J Clin Med. 2022 Jun 23;11(13):3635. doi: 10.3390/jcm11133635.
- Background: PubMed 37608327Monnet X, Lai C, Ospina-Tascon G, De Backer D. Evidence for a personalized early start of norepinephrine in septic shock. Crit Care. 2023 Aug 22;27(1):322. doi: 10.1186/s13054-023-04593-5.
- Background: PubMed 32059682Ospina-Tascon GA, Hernandez G, Alvarez I, Calderon-Tapia LE, Manzano-Nunez R, Sanchez-Ortiz AI, Quinones E, Ruiz-Yucuma JE, Aldana JL, Teboul JL, Cavalcanti AB, De Backer D, Bakker J. Effects of very early start of norepinephrine in patients with septic shock: a propensity score-based analysis. Crit Care. 2020 Feb 14;24(1):52. doi: 10.1186/s13054-020-2756-3.
- Background: PubMed 30704260Permpikul C, Tongyoo S, Viarasilpa T, Trainarongsakul T, Chakorn T, Udompanturak S. Early Use of Norepinephrine in Septic Shock Resuscitation (CENSER). A Randomized Trial. Am J Respir Crit Care Med. 2019 May 1;199(9):1097-1105. doi: 10.1164/rccm.201806-1034OC.
- Individual participant dataSharing planned: No
Related trials for Septic Shock
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
Sepsis, Septic Shock Hyperdynamic
RecruitingObservational study
Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
Sepsis
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.
Irfan Julio Nasution, MD principal investigator
Universitas Sumatera Utara
Questions about this trial
What is this clinical trial studying?
A study testing Norepinephrine and Crystalloid Fluid Resuscitation in people with Septic Shock and Acute Kidney Injury, run by Universitas Sumatera Utara.
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 5 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 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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 Irfan Julio Nasution, MD (+6285296993309, irfanjulionst@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Acute Kidney Injury (time frame: Within 48 hours after intervention). 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 NCT07418541, which also lists 4 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 18 Feb 2026.