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

NCT07232342 | Recruiting

• 1 other identifier: BenhaU123456789
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Peritonitis Infectious

Keywords

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

Outcome Measures

Primary Outcomes (1)

• all-cause mortality

  From 1-10-2025 to 1-10-2026

Study Arms (1)

adult patients admitted to the ICU with post-operative secondary peritonitis requiring an ICU stay o

Diagnostic Test: Capillary Leak Index Versus

Interventions

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

adult patients admitted to the ICU with post-operative secondary peritonitis requiring an ICU stay o

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adult patients admitted to the ICU with post-operative secondary peritonitis requiring an ICU stay of at least 48 hours will be enrolled.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University Hospital

Banhā, Qalyubia Governorate, 13511, Egypt

RECRUITING

MeSH Terms

Conditions

Peritonitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Peritoneal Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: December 10, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

EG (1)