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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07232342

Enrollment

100

Registered

2025-11-18

Start date

2025-12-10

Completion date

2026-10-30

Last updated

2025-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peritonitis Infectious

Keywords

Peritonitis, Capillary Leak Index, Conventional Biomarkers, Critically Ill Patients

Brief 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.

Interventions

DIAGNOSTIC_TESTCapillary Leak Index Versus

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
all-cause mortality	From 1-10-2025 to 1-10-2026

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026