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

ConditionSepsis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Center of Martinique

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

- 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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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 intervention

    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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: TEST GROUPExperimental treatment 1 intervention
Group B: Control group:Other 1 intervention

Trial outcomes

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.

Time frame
04 DAYS

Secondary outcomes

1

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
2

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
3

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

Other outcomes

Sponsors and contacts

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