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Clinical Trials/NCT07232342
NCT07232342RecruitingNot Applicable

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

Benha University1 site in 1 country100 target enrollmentStarted: December 10, 2025Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
100
Locations
1
Primary Endpoint
all-cause mortality
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

all-cause mortality

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Samar Rafik Mohamed Amin

Dr

Benha University

Study Sites (1)

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