Capillary Leak Index Versus Conventional Biomarkers in Predicting Sepsis-Related Outcomes

NCT07232342 — Completed, 100 participants, Benha University

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RegistryNCT07232342
StatusCompleted
Study typeObservational
Enrollment100 (Actual)
SponsorBenha University (Other)
ConditionsPeritonitis Infectious
InterventionsCapillary Leak Index Versus (Diagnostic test)
Datesstart 2025-12-10, primary completion 2026-10-01, completion 2026-10-15, first posted 2025-11-18, last updated 2026-10-20
Locations1 site in Egypt

Related Papers Related Patents Related Grants Related Experts
All trials for Peritonitis Infectious All trials of Capillary Leak Index Versus

-Summary

This study aims to evaluate the prognostic significance of CLI in predicting 28-day mortality and other outcomes in critically ill patients who develop post-operative abdominal sepsis.

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+Arms and interventions

ArmTypeInterventionsDescription
adult patients admitted to the ICU with post-operative secondary peritonitis requiring an ICU stay oDiagnostic Test: Capillary Leak Index Versus
  • Capillary Leak Index Versus (Diagnostic test): Blood samples will be collected at three time points: within 1-2 hours of ICU admission (Day 0), Day 1, Day 2 and Day 7, to monitor trends in CLI and conventional biomarkers during the ICU stay. • CR

+Outcome measures

Primary outcomes

  • all-cause mortality [From 1-10-2025 to 1-10-2026]

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

Age ≥ 18 years.

Postoperative secondary peritonitis requiring ICU admission, with clinical evidence of:

Diffuse or localized abdominal pain/tenderness. Peritoneal signs (e.g., guarding, rigidity, rebound tenderness). Imaging or intraoperative confirmation of purulent/exudative intra-abdominal fluid.

Systemic inflammation (e.g., fever, leukocytosis, or vasopressor requirement). Sepsis diagnosis per Sepsis-3 criteria: Suspected/confirmed infection with acute increase in SOFA score ≥2 points (6).

Anticipated ICU stay ≥48 hours postoperatively.

Exclusion Criteria:

* Pregnancy

  * Advanced liver disease (Child-Pugh class B or C) that might independently affect albumin levels
  * Advanced kidney disease (CKD stage 4 or 5) or patients on chronic dialysis
  * Expected mortality within 48 hours of ICU admission
  * Patients with primary peritonitis or tertiary peritonitis
  * Immunocompromised patients (e.g., on chronic immunosuppressive therapy, solid organ transplant recipients, patients with HIV and CD4 count <200/mm³)
  * Patients with pre-existing systemic inflammatory diseases that might affect baseline CRP levels
  * Patients participating in interventional trials that might affect outcomes

+Locations (1)

FacilityCityCountryStatus
Benha University HospitalBanhā, Qalyubia GovernorateEgypt