An interventional study of 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. and 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. in Sepsis, sponsored by University Hospital Center of Martinique. Not yet recruiting at 1 site in Martinique. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by University Hospital Center of Martinique · Not applicable, Interventional, and Diagnostic
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.
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.
1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.
This study's planned enrollment of 100 is above the median of 79 across 636 interventional studies indexed under Shock, Septic.
Browse Shock, Septic studies →University Hospital Center of Martinique is the lead sponsor of 79 studies on the registry; 21 are open to participants now.
Compared within Shock, Septic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Sepsis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Control group (non septic shock patients):
Exclusion Criteria:
Septic shock patients receiving standardised fluid resuscitation, with CLI computation, biomarker analysis (angiopoietin-2 and syndecan-1), and extracellular water evaluation using bioimpedance.
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.
Postoperative patients undergoing standardised fluid resuscitation, CLI computation and biomarker analysis (angiopoietin-2 and syndecan-1)
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.
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.
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
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.
Time frame: 04 DAYS
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
Time frame: 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.
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.
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
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Oct 2028, 25 months later.
Of 164 non-industry interventional studies with no phase under Shock, Septic, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 41. This study's planned 25 months is close to that.
Counting every sponsor, half of 172 studies reached it within 25 months; a quarter within 12 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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University Hospital Center of Martinique