Validation of a Capillary Leak Index During Septic Shock, Based on Haemoglobin Level Variations Induced by Fluid Resuscitation. A Pilot Study.

NCT07733206 | Not Yet Recruiting

• 1 other identifier: 25_RIPH2-05
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Sepsis

Keywords

Septic shock; capillary leak; endothelial dysfunction; angiopoietin-2; syndecan-1; fluid resuscitation; haemoglobin variation; extracellular water; bio-impedance

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  04 DAYS

• Difference in CLI at Day 0 between patients with septic shock and those without.

  01 DAY

• Odds ratio (95% CI) for the association between 30-day mortality and CLI measured at Day 0 in patients with septic shock.

  30 DAYS

Study Arms (2)

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.

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)

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.

Interventions

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.

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. 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

Control group:

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University Hospital Center of Martinique: lead

Study Sites (1)

CHUM

Fort-de-France, Martinique, 97261, Martinique

Location

MeSH Terms

Conditions

Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• PATRICK ROYER, DR

  CHU MARTINIQUE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SARAH-PRESCILLIA JOSEPH, MSC

CONTACT

0596592696; SARAH-PRESCILLIA.JOSEPG@CHU6MARTINIQUE.FR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 29, 2026
• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): October 15, 2028
• Study Completion (Estimated): October 15, 2028
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)