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NCT Number: NCT07232342

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Benha University Hospital

Banhā, Qalyubia Governorate, 13511, Egypt

Location status: Recruiting

Location contact

Samar assistant professor, MD

CONTACT

[email protected]

+201287793991

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. all-cause mortality

    Time frame: From 1-10-2025 to 1-10-2026

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 18, 2025
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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