Trial Outcomes & Findings for Capillary Leak Index as a Prognostic Indicator for Post-Operative Abdominal Sepsis in Critically Ill Patients (NCT NCT06901544)

Last Updated: 2025-12-24

Results Overview

Baseline CLI will be calculated on ICU admission . Mortality status (alive or dead) will be assessed at 28 days after ICU admission. The primary outcome is the number of participants who died from any cause by day 28 after ICU admission. The Association between basline CLI and 28-day all- cause mortality will be evaluated.

Recruitment status

COMPLETED

Target enrollment

100 participants

Primary outcome timeframe

28 days after ICU admission

Results posted on

2025-12-24

Participant Flow

"100 Participants were recruited from Surgical intensive Care Unit, Ain Shams University Hospitals. In between March 2025 and Aug 2025." "Recruitment was conducted through ICU."

the 100 participants enrolled. * 50 participants of CLI at or less than of cutoff point 85.55 were enrolled. * 50 participants of CLI more than of cutoff point 85.55 were enrolled.

Participant milestones

Participant milestones
Measure	Low CLI at or Less Than Cutoff Point 85.55 50 Participants patient with Post operative Intra-abdominal sepsis with CLI at or less than 85.55 the cutoff point. This group included 100 adult ICU patients with post-operative secondary intra-abdominal sepsis. The Capillary Leak Index (CLI) was calculated for each participant using the formula: (CRP ÷ Albumin) × 100. Patients were stratified into low and high CLI subgroups according to the cutoff Point of 85.55 for prognostic analysis.	High CLI More Than Cutoff Point 85.55 50 Participants patient with Post operative Intra-abdominal sepsis with High CLI more than 85.55 the cutoff point. This group included 100 adult ICU patients with post-operative secondary intra-abdominal sepsis. The Capillary Leak Index (CLI) was calculated for each participant using the formula: (CRP ÷ Albumin) × 100. Patients were stratified into low and high CLI subgroups according to the cutoff Point of 85.55 for prognostic analysis.
Overall Study STARTED	50	50
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Low CLI Equal or Less Than 85.55 Cutoff Point. n=50 Participants Adult ICU Patients with secondary peritonitis who had a baseline capillary leak index at or less than cutoff points 85.55 were enrolled with 48 hours of ICU admission and followed for 28 days mortality.	High CLI Greater Than 85.55 Cutoff Point. n=50 Participants Adult ICU Patients with secondary peritonitis who had a baseline capillary leak index more than cutoff points 85.55 were enrolled with 48 hours of ICU admission and followed for 28 days mortality.	Total n=100 Participants Total of all reporting groups
Age, Customized Age	56 Age (years) n=50 Participants	60 Age (years) n=50 Participants	58 Age (years) n=100 Participants
Sex: Female, Male Female	13 Participants n=50 Participants	12 Participants n=50 Participants	25 Participants n=100 Participants
Sex: Female, Male Male	37 Participants n=50 Participants	38 Participants n=50 Participants	75 Participants n=100 Participants
Diabetes mellitus disease (DM) positive	14 Participants n=50 Participants	18 Participants n=50 Participants	32 Participants n=100 Participants
Diabetes mellitus disease (DM) negative	36 Participants n=50 Participants	32 Participants n=50 Participants	68 Participants n=100 Participants
Cardiovascular diseases positive	19 Participants n=50 Participants	17 Participants n=50 Participants	36 Participants n=100 Participants
Cardiovascular diseases negative	31 Participants n=50 Participants	33 Participants n=50 Participants	64 Participants n=100 Participants
Hepatic diseases Positive	1 Participants n=50 Participants	2 Participants n=50 Participants	3 Participants n=100 Participants
Hepatic diseases Negative	49 Participants n=50 Participants	48 Participants n=50 Participants	97 Participants n=100 Participants
Renal diseases positive	6 Participants n=50 Participants	9 Participants n=50 Participants	15 Participants n=100 Participants
Renal diseases negative	44 Participants n=50 Participants	41 Participants n=50 Participants	85 Participants n=100 Participants
surgical history positive	22 Participants n=50 Participants	16 Participants n=50 Participants	38 Participants n=100 Participants
surgical history negative	28 Participants n=50 Participants	34 Participants n=50 Participants	62 Participants n=100 Participants
Drugs History positive	27 Participants n=50 Participants	24 Participants n=50 Participants	51 Participants n=100 Participants
Drugs History negative	23 Participants n=50 Participants	26 Participants n=50 Participants	49 Participants n=100 Participants
Acute Physiology and Chronic Health Evaluation (APACHE II),Sequential Organ Failure Assessment(SOFA) APACHE II Score	19.5 Score on a Scale n=50 Participants	21.5 Score on a Scale n=50 Participants	20.5 Score on a Scale n=100 Participants
Acute Physiology and Chronic Health Evaluation (APACHE II),Sequential Organ Failure Assessment(SOFA) SOFA Score	6.5 Score on a Scale n=50 Participants	10.5 Score on a Scale n=50 Participants	8.5 Score on a Scale n=100 Participants
Abdominal Pain Pain Onset	6.02 days STANDARD_DEVIATION 4.44 • n=50 Participants	5.5 days STANDARD_DEVIATION 4.19 • n=50 Participants	5.76 days STANDARD_DEVIATION 4.3 • n=100 Participants
Abdominal Pain Pain Duration	6.28 days STANDARD_DEVIATION 4.39 • n=50 Participants	6.55 days STANDARD_DEVIATION 4.75 • n=50 Participants	6.42 days STANDARD_DEVIATION 4.55 • n=100 Participants
GIT symptoms positive	32 Participants n=50 Participants	18 Participants n=50 Participants	50 Participants n=100 Participants
GIT symptoms negative	18 Participants n=50 Participants	32 Participants n=50 Participants	50 Participants n=100 Participants
Kidney function tests Urea	62.18 mg/dL n=50 Participants	85.1 mg/dL n=50 Participants	73.64 mg/dL n=100 Participants
Kidney function tests Creatinine	1.56 mg/dL n=50 Participants	2.53 mg/dL n=50 Participants	2.045 mg/dL n=100 Participants
C Reactive Protein (CRP)	14.8 mg/dL n=50 Participants	31.11 mg/dL n=50 Participants	22.955 mg/dL n=100 Participants
Fever positive	6 Participants n=50 Participants	6 Participants n=50 Participants	12 Participants n=100 Participants
Fever negative	44 Participants n=50 Participants	44 Participants n=50 Participants	88 Participants n=100 Participants
Albumin	32.52 g/L n=50 Participants	26.62 g/L n=50 Participants	29.57 g/L n=100 Participants
Body Mass Index (BMI)	23.57 (kg/m2) STANDARD_DEVIATION 2.84 • n=50 Participants	24.16 (kg/m2) STANDARD_DEVIATION 2.66 • n=50 Participants	23.87 (kg/m2) STANDARD_DEVIATION 2.75 • n=100 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 28 days after ICU admission

Outcome measures

Outcome measures
Measure	Low CLI equal or less than 85.55 cutoff point. n=50 Participants Adult ICU Patients with secondary peritonitis who had a baseline capillary leak index at or less than cutoff points 85.55 were enrolled with 48 hours of ICU admission and followed for 28 days mortality.	High CLI greater than 85.55 cutoff point. n=50 Participants Adult ICU Patients with secondary peritonitis who had a baseline capillary leak index more than cutoff points 85.55 were enrolled with 48 hours of ICU admission and followed for 28 days mortality.
Number of Participants Who Died by Day 28	8 Participants Interval 3.0 to 20.0	23 Participants Interval 2.0 to 16.0

SECONDARY outcome

Timeframe: up to 28 days

ICU Stay \[Unit: more than 3 Days\].

Outcome measures

Outcome measures
Measure	Low CLI equal or less than 85.55 cutoff point. n=50 Participants Adult ICU Patients with secondary peritonitis who had a baseline capillary leak index at or less than cutoff points 85.55 were enrolled with 48 hours of ICU admission and followed for 28 days mortality.	High CLI greater than 85.55 cutoff point. n=50 Participants Adult ICU Patients with secondary peritonitis who had a baseline capillary leak index more than cutoff points 85.55 were enrolled with 48 hours of ICU admission and followed for 28 days mortality.
ICU Stay [Unit: More Than 3 Days].	7.96 days Interval 5.0 to 10.0	8.78 days Interval 7.0 to 12.0

SECONDARY outcome

Timeframe: up to 3 days

The Relationship Between Variables: The investigators will analyze CLI as a prognostic indicator using logistic regression to predict risk of ICU mortality.

Outcome measures

Outcome measures
Measure	Low CLI equal or less than 85.55 cutoff point. n=50 Participants Adult ICU Patients with secondary peritonitis who had a baseline capillary leak index at or less than cutoff points 85.55 were enrolled with 48 hours of ICU admission and followed for 28 days mortality.	High CLI greater than 85.55 cutoff point. n=50 Participants Adult ICU Patients with secondary peritonitis who had a baseline capillary leak index more than cutoff points 85.55 were enrolled with 48 hours of ICU admission and followed for 28 days mortality.
Procalcitonin [Unit: ng/mL] [Time Frame: 3 Days]	8.65 ng/ml Standard Deviation 16.55 • Interval 0.05 to 90.0	16.62 ng/ml Standard Deviation 20.63 • Interval 0.05 to 86.0

Adverse Events

Low CLI Equal or Less Than 85.55 Cutoff Point.

Serious events: 27 serious events

Other events: 14 other events

Deaths: 8 deaths

High CLI Greater Than 85.55 Cutoff Point.

Serious events: 35 serious events

Other events: 19 other events

Deaths: 23 deaths

Serious adverse events

Serious adverse events
Measure	Low CLI Equal or Less Than 85.55 Cutoff Point. n=50 participants at risk Adult ICU Patients with secondary peritonitis who had a baseline capillary leak index at or less than cutoff points 85.55 were enrolled with 48 hours of ICU admission and followed for 28 days mortality.	High CLI Greater Than 85.55 Cutoff Point. n=50 participants at risk Adult ICU Patients with secondary peritonitis who had a baseline capillary leak index more than cutoff points 85.55 were enrolled with 48 hours of ICU admission and followed for 28 days mortality.
Blood and lymphatic system disorders Disseminated intravascular coagulation (DIC)	2.0% 1/50 • Number of events 2 • from the second day of ICU admission until end of follow-up, up to 28 days. "Adverse events were defined according to ClinicalTrials.gov standards. All participants were monitored daily during ICU stay and throughout the 28-day follow-up. Events were assessed by the study investigators and included in the analysis for the entire enrolled population."	0.00% 0/50 • from the second day of ICU admission until end of follow-up, up to 28 days. "Adverse events were defined according to ClinicalTrials.gov standards. All participants were monitored daily during ICU stay and throughout the 28-day follow-up. Events were assessed by the study investigators and included in the analysis for the entire enrolled population."
Renal and urinary disorders Acute Kidney injury (AKI)	30.0% 15/50 • Number of events 15 • from the second day of ICU admission until end of follow-up, up to 28 days. "Adverse events were defined according to ClinicalTrials.gov standards. All participants were monitored daily during ICU stay and throughout the 28-day follow-up. Events were assessed by the study investigators and included in the analysis for the entire enrolled population."	34.0% 17/50 • Number of events 17 • from the second day of ICU admission until end of follow-up, up to 28 days. "Adverse events were defined according to ClinicalTrials.gov standards. All participants were monitored daily during ICU stay and throughout the 28-day follow-up. Events were assessed by the study investigators and included in the analysis for the entire enrolled population."
General disorders Multi Organ Disfunctions	8.0% 4/50 • Number of events 4 • from the second day of ICU admission until end of follow-up, up to 28 days. "Adverse events were defined according to ClinicalTrials.gov standards. All participants were monitored daily during ICU stay and throughout the 28-day follow-up. Events were assessed by the study investigators and included in the analysis for the entire enrolled population."	12.0% 6/50 • Number of events 6 • from the second day of ICU admission until end of follow-up, up to 28 days. "Adverse events were defined according to ClinicalTrials.gov standards. All participants were monitored daily during ICU stay and throughout the 28-day follow-up. Events were assessed by the study investigators and included in the analysis for the entire enrolled population."
Respiratory, thoracic and mediastinal disorders Acute Respiratory Distress Syndrome	14.0% 7/50 • Number of events 7 • from the second day of ICU admission until end of follow-up, up to 28 days. "Adverse events were defined according to ClinicalTrials.gov standards. All participants were monitored daily during ICU stay and throughout the 28-day follow-up. Events were assessed by the study investigators and included in the analysis for the entire enrolled population."	24.0% 12/50 • Number of events 12 • from the second day of ICU admission until end of follow-up, up to 28 days. "Adverse events were defined according to ClinicalTrials.gov standards. All participants were monitored daily during ICU stay and throughout the 28-day follow-up. Events were assessed by the study investigators and included in the analysis for the entire enrolled population."

Other adverse events

Other adverse events
Measure	Low CLI Equal or Less Than 85.55 Cutoff Point. n=50 participants at risk Adult ICU Patients with secondary peritonitis who had a baseline capillary leak index at or less than cutoff points 85.55 were enrolled with 48 hours of ICU admission and followed for 28 days mortality.	High CLI Greater Than 85.55 Cutoff Point. n=50 participants at risk Adult ICU Patients with secondary peritonitis who had a baseline capillary leak index more than cutoff points 85.55 were enrolled with 48 hours of ICU admission and followed for 28 days mortality.
Gastrointestinal disorders constipation	4.0% 2/50 • Number of events 2 • from the second day of ICU admission until end of follow-up, up to 28 days. "Adverse events were defined according to ClinicalTrials.gov standards. All participants were monitored daily during ICU stay and throughout the 28-day follow-up. Events were assessed by the study investigators and included in the analysis for the entire enrolled population."	4.0% 2/50 • Number of events 2 • from the second day of ICU admission until end of follow-up, up to 28 days. "Adverse events were defined according to ClinicalTrials.gov standards. All participants were monitored daily during ICU stay and throughout the 28-day follow-up. Events were assessed by the study investigators and included in the analysis for the entire enrolled population."
Gastrointestinal disorders Vomiting	12.0% 6/50 • Number of events 16 • from the second day of ICU admission until end of follow-up, up to 28 days. "Adverse events were defined according to ClinicalTrials.gov standards. All participants were monitored daily during ICU stay and throughout the 28-day follow-up. Events were assessed by the study investigators and included in the analysis for the entire enrolled population."	14.0% 7/50 • Number of events 7 • from the second day of ICU admission until end of follow-up, up to 28 days. "Adverse events were defined according to ClinicalTrials.gov standards. All participants were monitored daily during ICU stay and throughout the 28-day follow-up. Events were assessed by the study investigators and included in the analysis for the entire enrolled population."
Immune system disorders fever	12.0% 6/50 • Number of events 6 • from the second day of ICU admission until end of follow-up, up to 28 days. "Adverse events were defined according to ClinicalTrials.gov standards. All participants were monitored daily during ICU stay and throughout the 28-day follow-up. Events were assessed by the study investigators and included in the analysis for the entire enrolled population."	20.0% 10/50 • Number of events 10 • from the second day of ICU admission until end of follow-up, up to 28 days. "Adverse events were defined according to ClinicalTrials.gov standards. All participants were monitored daily during ICU stay and throughout the 28-day follow-up. Events were assessed by the study investigators and included in the analysis for the entire enrolled population."

Additional Information

Osama Khalil

Ain Shams University, Faculty of Medicine

Phone: 01010000903

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place