SepsisIFC-sepsisNCT07733206
Validation of a Capillary Leak Index During Septic Shock, Based on Haemoglobin Level Variations Induced by Fluid Resuscitation. A Pilot Study.
A study testing TEST GROUP: A standardised fluid bolus of 8 mL/kg of ideal body weight using Ringer's lactate will be administered in septic shock patients. in people with Sepsis, run by University Hospital Center of Martinique at 1 site in Martinique.
Trial summary
This study aims to validate a simple and reproducible index of capillary leak (CLI) in septic shock, based on haemoglobin (Hb) variation induced by standardised fluid resuscitation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- TEST GROUP: A standardised fluid bolus of 8 mL/kg of ideal body weight using Ringer's lactate will be administered in septic shock patients.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteMartinique
- Study dates
- 15 Sep 2026to 15 Oct 2028
- 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
- Test group (septic shock patients):
- Adults admitted to the general ICU within 24 hours with a diagnosis of septic shock
- Eligible for blood sampling during daytime hours
- Control group (non septic shock patients):
- Adults admitted to the postoperative ICU within 24 hours after surgery
- Need for fluid resuscitation
- Eligible for blood sampling during daytime hours
- Patients with an arterial catheter in place as part of their care
Who cannot join
- - Clarkson's disease (idiopathic capillary leak syndrome)
- Pre-existing extracellular fluid overload (e.g., cirrhosis, decompensated heart failure, nephrotic syndrome, chronic kidney disease on or awaiting dialysis)
- Active bleeding or hemolysis
- Receiving ECMO
- Ongoing renal replacement therapy during the intervention
- Blood transfusion within one hour before the intervention
- Change in vasopressor or inotrope dose within 30 minutes before the intervention
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Martinique1 site
CHUM
Fort-de-France, Martinique, 97261
SARAH-PRESCILLIA JOSEPH, MSC, 0596592696 ext. +596, SARAH-PRESCILLIA.JOSEPH@CHU-MARTINIQUE.FR
PATRICK ROYER, DR
About this study
This study aims to validate a simple and reproducible index of capillary leak (CLI) in septic shock, based on haemoglobin (Hb) variation induced by standardised fluid resuscitation. To achieve this, the correlation between CLI and biomarkers of endothelial dysfunction-angiopoietin-2 and syndecan-1-will be assessed in both septic and non-septic shock patients. CLI may contribute to the individualisation of fluid management in patients with septic shock.
Read the detailed description
Septic shock is characterised by systemic inflammation leading to endothelial dysfunction and increased capillary permeability. This results in intravascular hypovolaemia and interstitial oedema, contributing to tissue hypoperfusion and organ failure. Despite the prognostic implications, bedside assessment of capillary leak remains difficult, with no simple or standardised method available. Fluid resuscitation is the first-line therapy for circulatory failure in septic shock, but excessive fluid administration has been associated with increased mortality. Recent trials investigating restrictive fluid strategies have failed to show a survival benefit, likely due to the lack of patient stratification based on the severity of capillary leak. A bedside marker could guide personalised fluid and vasopressor therapy.
A standardised fluid bolus (8 ml/kg of ideal body weight, Ringer's lactate) will be administered in both septic and non-septic shock patients. Haemoglobin levels will be measured before and after infusion, and the CLI will be calculated as (Hb pre - Hb post) / Hb pre * 100. Bioimpedance analysis will be used to estimate extracellular water in selected patients.
- Conditions
- Sepsis
- Being tested
- TEST GROUP: A standardised fluid bolus of 8 mL/kg of ideal body weight using Ringer's lactate will be administered in septic shock patients., CONTROL GROUP: A standardised fluid bolus of 8 mL/kg of ideal body weight using Ringer's lactate will be administered in non-septic postoperative patients.
- Keywords
- Septic shock, capillary leak, endothelial dysfunction, angiopoietin-2, syndecan-1, fluid resuscitation, haemoglobin variation, extracellular water, bio-impedance
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEST GROUP: A standardised fluid bolus of 8 mL/kg of ideal body weight using Ringer's lactate will be administered in septic shock patients.Other
A standardised fluid bolus of 8 mL/kg of ideal body weight using Ringer's lactate will be administered in septic shock patients. Haemoglobin levels will be measured before and after the infusion, and CLI will be calculated using the following formula:
CLI = (Hb pre - Hb post) / Hb pre * 100 In selected patients, extracellular water volume will be estimated using bioimpedance analysis.
CONTROL GROUP: A standardised fluid bolus of 8 mL/kg of ideal body weight using Ringer's lactate will be administered in non-septic postoperative patients.Other
Description: A standardised fluid bolus of 8 mL/kg of ideal body weight using Ringer's lactate will be administered in non-septic postoperative patients. Haemoglobin levels will be measured before and after the infusion, and CLI will be calculated using the following formula: CLI = (Hb pre - Hb post) / Hb pre * 100
| Study group | Role | What they receive |
|---|---|---|
| TEST GROUP | Experimental | Septic shock patients receiving standardised fluid resuscitation, with CLI computation, biomarker analysis (angiopoietin-2 and syndecan-1), and extracellular water evaluation using bioimpedance. Receives: Other: TEST GROUP: A standardised fluid bolus of 8 mL/kg of ideal body weight using Ringer's lactate will be administered in septic shock patients. |
| Control group: | Other | Postoperative patients undergoing standardised fluid resuscitation, CLI computation and biomarker analysis (angiopoietin-2 and syndecan-1) Receives: Other: CONTROL GROUP: A standardised fluid bolus of 8 mL/kg of ideal body weight using Ringer's lactate will be administered in non-septic postoperative patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation coefficient between CLI and serum levels of angiopoietin-2 and syndecan-1 at inclusion (Day 0) and on Day 3 in patients with septic shock.
Correlation coefficient between CLI and serum levels of angiopoietin-2 and syndecan-1 at inclusion (Day 0) and on Day 3 in patients with septic shock.
Measured: 04 DAYS
Secondary outcomes (3)
Correlation coefficient between CLI at Day 0 and extracellular water accumulation from Day 0 to Day 3, assessed by bioimpedance, in patients with septic shock
Correlation coefficient between CLI at Day 0 and extracellular water accumulation from Day 0 to Day 3, assessed by bioimpedance, in patients with septic shock
Measured: 04 DAYS
Difference in CLI at Day 0 between patients with septic shock and those without.
Difference in CLI at Day 0 between patients with septic shock and those without.
Measured: 01 DAY
Odds ratio (95% CI) for the association between 30-day mortality and CLI measured at Day 0 in patients with septic shock.
Odds ratio (95% CI) for the association between 30-day mortality and CLI measured at Day 0 in patients with septic shock.
Measured: 30 DAYS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start15 Sep 2026 (estimated)
- Primary completion15 Oct 2028 (estimated)
- Study completion15 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- PATRICK ROYER, DR, Principal investigator, CHU MARTINIQUE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07733206
- Sponsor's protocol ID
- 25_RIPH2-05
- Acronym
- IFC-sepsis
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Capillary Leak Index During Septic Shock, Based on Haemoglobin Level Variations Induced by Fluid Resuscitation. A Pilot Study.
- ClinicalTrials.gov ID
- NCT07733206
- Acronym / sponsor ID
- IFC-sepsis / 25_RIPH2-05
- Conditions
- Sepsis
- Keywords
- Septic shock, capillary leak, endothelial dysfunction, angiopoietin-2, syndecan-1, fluid resuscitation, haemoglobin variation, extracellular water
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 15 Oct 2028 (estimated)
- Study completion
- 15 Oct 2028 (estimated)
- First posted
- 29 Jul 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.
This study aims to validate a simple and reproducible index of capillary leak (CLI) in septic shock, based on haemoglobin (Hb) variation induced by standardised fluid resuscitation. To achieve this, the correlation between CLI and biomarkers of endothelial dysfunction-angiopoietin-2 and syndecan-1-will be assessed in both septic and non-septic shock patients. CLI may contribute to the individualisation of fluid management in patients with septic shock.
Detailed description
Septic shock is characterised by systemic inflammation leading to endothelial dysfunction and increased capillary permeability. This results in intravascular hypovolaemia and interstitial oedema, contributing to tissue hypoperfusion and organ failure. Despite the prognostic implications, bedside assessment of capillary leak remains difficult, with no simple or standardised method available. Fluid resuscitation is the first-line therapy for circulatory failure in septic shock, but excessive fluid administration has been associated with increased mortality. Recent trials investigating restrictive fluid strategies have failed to show a survival benefit, likely due to the lack of patient stratification based on the severity of capillary leak. A bedside marker could guide personalised fluid and vasopressor therapy.
A standardised fluid bolus (8 ml/kg of ideal body weight, Ringer's lactate) will be administered in both septic and non-septic shock patients. Haemoglobin levels will be measured before and after infusion, and the CLI will be calculated as (Hb pre - Hb post) / Hb pre * 100. Bioimpedance analysis will be used to estimate extracellular water in selected patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEST GROUP | Experimental | Other: TEST GROUP: A standardised fluid bolus of 8 mL/kg of ideal body weight using Ringer's lactate will be administered in septic shock patients.Septic shock patients receiving standardised fluid resuscitation, with CLI computation, biomarker analysis (angiopoietin-2 and syndecan-1), and extracellular water evaluation using bioimpedance. |
| Control group: | Other | Other: CONTROL GROUP: A standardised fluid bolus of 8 mL/kg of ideal body weight using Ringer's lactate will be administered in non-septic postoperative patients.Postoperative patients undergoing standardised fluid resuscitation, CLI computation and biomarker analysis (angiopoietin-2 and syndecan-1) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Test group (septic shock patients):
- Adults admitted to the general ICU within 24 hours with a diagnosis of septic shock
- Eligible for blood sampling during daytime hours
- Adults admitted to the postoperative ICU within 24 hours after surgery
- Need for fluid resuscitation
Key exclusion criteria (7 listed)
- - Clarkson's disease (idiopathic capillary leak syndrome)
- Pre-existing extracellular fluid overload (e.g., cirrhosis, decompensated heart failure, nephrotic syndrome, chronic kidney disease on or awaiting dialysis)
- Active bleeding or hemolysis
- Receiving ECMO
- Ongoing renal replacement therapy during the intervention
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 |
|---|---|---|
| TEST GROUP: A standardised fluid bolus of 8 mL/kg of ideal body weight using Ringer's lactate will be administered in septic shock patients.A standardised fluid bolus of 8 mL/kg of ideal body weight using Ringer's lactate will be administered in septic shock patients. Haemoglobin levels will be measured before and after the infusion, and CLI will be calculated using the following formula: CLI = (Hb pre - Hb post) / Hb pre * 100 In selected patients, extracellular water volume will be estimated using bioimpedance analysis. | Other | TEST GROUP |
| CONTROL GROUP: A standardised fluid bolus of 8 mL/kg of ideal body weight using Ringer's lactate will be administered in non-septic postoperative patients.Description: A standardised fluid bolus of 8 mL/kg of ideal body weight using Ringer's lactate will be administered in non-septic postoperative patients. Haemoglobin levels will be measured before and after the infusion, and CLI will be calculated using the following formula: CLI = (Hb pre - Hb post) / Hb pre * 100 | Other | Control group: |
Primary outcome
Correlation coefficient between CLI and serum levels of angiopoietin-2 and syndecan-1 at inclusion (Day 0) and on Day 3 in patients with septic shock.
Time frame: 04 DAYS
Correlation coefficient between CLI and serum levels of angiopoietin-2 and syndecan-1 at inclusion (Day 0) and on Day 3 in patients with septic shock.
3 secondary outcomes
Correlation coefficient between CLI at Day 0 and extracellular water accumulation from Day 0 to Day 3, assessed by bioimpedance, in patients with septic shock
Time frame: 04 DAYS
Difference in CLI at Day 0 between patients with septic shock and those without.
Time frame: 01 DAY
Odds ratio (95% CI) for the association between 30-day mortality and CLI measured at Day 0 in patients with septic shock.
Time frame: 30 DAYS
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 29 Jul 2026.
- 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.
PATRICK ROYER, DR principal investigator
CHU MARTINIQUE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEST GROUP: A standardised fluid bolus of 8 mL/kg of ideal body weight using Ringer's lactate will be administered in septic shock patients. in people with Sepsis, run by University Hospital Center of Martinique at 1 site in Martinique.
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 8 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 29 Jul 2026. 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 Martinique. 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?
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 SARAH-PRESCILLIA JOSEPH, MSC (0596592696 ext. +596, SARAH-PRESCILLIA.JOSEPG@CHU6MARTINIQUE.FR), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation coefficient between CLI and serum levels of angiopoietin-2 and syndecan-1 at inclusion (Day 0) and on Day 3 in patients with septic shock. (time frame: 04 DAYS). 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 29 Jul 2026.