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Recruiting NCT07232342

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

Observational Peritonitis Infectious

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Capillary Leak Index Versus.
Who it may be relevant to
Registry conditions: Peritonitis Infectious. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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 test Capillary 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

Primary outcome measures

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

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Egypt · 1 center
  • Benha University Hospital — Banhā

Identifiers

NCT: NCT07232342 · BenhaU123456789

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗