Appendicitis Acute, Intestinal Obstruction, Intra-Abdominal Infections, Perforated Viscus
Conditions
Keywords
Capillary Leak Index, secondary abdominal sepsis, sepsis, Prognostic value, Good indicator, mortality, Intensive Care Unit, ICU
Brief summary
In this study the investigators going to evaluate the CLI as an early prognostic indicator for post-operative abdominal sepsis in critically ill patients.
Detailed description
Sepsis has been recognized as a life-threatening organ dysfunction caused by a dysregulated host response to infection. Considerable advances have since been made into the pathobiology (changes in organ function, morphology, cell biology, biochemistry, immunology, and circulation), management, and epidemiology of sepsis, suggesting the need for continuous research. Peritonitis can be classified by the anatomical integrity of the abdominal cavity. Primary peritonitis is associated with undamaged intra-abdominal cavity organs. It is also known as spontaneous bacterial peritonitis and is treated without surgical intervention. The source of infection is often hard to establish and is usually found occurring in infants and cirrhotic patients. Secondary peritonitis is an infection of the peritoneal cavity after hollow viscus perforation, anastomotic leak, ischemic necrosis, or other injuries of the gastrointestinal tract. Tertiary peritonitis is defined as a serious recurrent or persistent intra-abdominal infection after the successful control of secondary peritonitis. Irrespective of the cause, several measures are available and accepted as improving the survival rate, the most important being the early recognition of intra-abdominal infection. Efforts to achieve fluid balance should be initiated immediately to replace any intravascular insufficiency. Vasoactive agents may be necessary to augment and assist fluid restoration. The treatment strategy for peritonitis primarily aims at the stabilization of possible organ dysfunction by routine intensive care medicine. Low risk secondary peritonitis (localized peritonitis), Ampicillin/Sulbactam or Carbapenem can be used as a monotherapy, however in combination therapy 2nd generation Cephalosporin + Metronidazole or 3rd generation Cephalosporin + Metronidazole can be used. High risk Secondary peritonitis Piperacillin/Tazobactam or Carbapenem or Tigecycline can be used as a monotherapy. A combination therapy 4th generation Cephalosporin + Metronidazole are usually used. Tertiary peritonitis antifungal therapy in high-risk patients and empirical therapy should cover the probable micro flora and should be changed according to the culture results. Capillary leak syndrome (CLS) refers to a syndrome of deranged fluid homeostasis, often observed in critically ill patients, CLS is frequently defined by excessive fluid shift from the intravascular to the extravascular space, resulting in intravascular hypovolemia, extravascular edema formation, and hypo perfusion necessitating further fluid resuscitation. In health, fluid exchange between intravascular and extravascular spaces is vital for maintaining the body's homeostasis. However, disturbances in this delicate equilibrium, can lead to the clinical picture of CLS. CLI is measured by dividing CRP level by albumin level. Systematic response to tissue injury, including major surgery, is marked by increased pro inflammatory cytokines, which promotes CRP production and capillary leakage. If the injury still exists, inflammatory process will continue. Our study will be done to evaluate the association between capillary leak index (CLI) and intensive care unit (ICU) related mortality in patients underwent major abdominal surgery.
Interventions
None listed
Sponsors
Ain Shams University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Age: ≥18 years old presented with Post-operative intra-abdominal sepsis due to secondary peritonitis. * Sex: Both sexes. * Post-Operative secondary peritonitis eg. Perforated viscus and abdominal abscess. * Estimated length of ICU stays ≥48 hrs.
Exclusion criteria
* Patient refusal. * Advanced Liver diseases According New MELD score ≥ 20 )Kamath et al.,2001) * Renal diseases (Moderate decrease in GFR 30-59 ml/min/1.73m²--Severe decrease in GFR 15-29 ml/min/1.73m²--Kidney failure less than 15 ml/min/1.73m² or on Hemodialysis). * Pregnancy. * Primary peritonitis. * Tertiary peritonitis. * Mortality within first 48hrs of ICU admission. * Advanced malignancy ( Stage III localized malignancy with spreading lymph nodes Stage IV spreading to Other parts of the body such as to the liver, lungs and bones).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Died by Day 28 | 28 days after ICU admission | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICU Stay [Unit: More Than 3 Days]. | up to 28 days | ICU Stay \[Unit: more than 3 Days\]. |
| Procalcitonin [Unit: ng/mL] [Time Frame: 3 Days] | 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. |
Countries
Egypt
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Low CLI Equal or Less Than 85.55 Cutoff Point. 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. | 50 |
| High CLI Greater Than 85.55 Cutoff Point. 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. | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | Low CLI Equal or Less Than 85.55 Cutoff Point. | High CLI Greater Than 85.55 Cutoff Point. | Total |
|---|---|---|---|
| Abdominal Pain Pain Duration | 6.28 days STANDARD_DEVIATION 4.39 | 6.55 days STANDARD_DEVIATION 4.75 | 6.42 days STANDARD_DEVIATION 4.55 |
| Abdominal Pain Pain Onset | 6.02 days STANDARD_DEVIATION 4.44 | 5.5 days STANDARD_DEVIATION 4.19 | 5.76 days STANDARD_DEVIATION 4.3 |
| Acute Physiology and Chronic Health Evaluation (APACHE II),Sequential Organ Failure Assessment(SOFA) APACHE II Score | 19.5 Score on a Scale | 21.5 Score on a Scale | 20.5 Score on a Scale |
| Acute Physiology and Chronic Health Evaluation (APACHE II),Sequential Organ Failure Assessment(SOFA) SOFA Score | 6.5 Score on a Scale | 10.5 Score on a Scale | 8.5 Score on a Scale |
| Age, Customized Age | 56 Age (years) | 60 Age (years) | 58 Age (years) |
| Albumin | 32.52 g/L | 26.62 g/L | 29.57 g/L |
| Body Mass Index (BMI) | 23.57 (kg/m2) STANDARD_DEVIATION 2.84 | 24.16 (kg/m2) STANDARD_DEVIATION 2.66 | 23.87 (kg/m2) STANDARD_DEVIATION 2.75 |
| Cardiovascular diseases negative | 31 Participants | 33 Participants | 64 Participants |
| Cardiovascular diseases positive | 19 Participants | 17 Participants | 36 Participants |
| C Reactive Protein (CRP) | 14.8 mg/dL | 31.11 mg/dL | 22.955 mg/dL |
| Diabetes mellitus disease (DM) negative | 36 Participants | 32 Participants | 68 Participants |
| Diabetes mellitus disease (DM) positive | 14 Participants | 18 Participants | 32 Participants |
| Drugs History negative | 23 Participants | 26 Participants | 49 Participants |
| Drugs History positive | 27 Participants | 24 Participants | 51 Participants |
| Fever negative | 44 Participants | 44 Participants | 88 Participants |
| Fever positive | 6 Participants | 6 Participants | 12 Participants |
| GIT symptoms negative | 18 Participants | 32 Participants | 50 Participants |
| GIT symptoms positive | 32 Participants | 18 Participants | 50 Participants |
| Hepatic diseases Negative | 49 Participants | 48 Participants | 97 Participants |
| Hepatic diseases Positive | 1 Participants | 2 Participants | 3 Participants |
| Kidney function tests Creatinine | 1.56 mg/dL | 2.53 mg/dL | 2.045 mg/dL |
| Kidney function tests Urea | 62.18 mg/dL | 85.1 mg/dL | 73.64 mg/dL |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Renal diseases negative | 44 Participants | 41 Participants | 85 Participants |
| Renal diseases positive | 6 Participants | 9 Participants | 15 Participants |
| Sex: Female, Male Female | 13 Participants | 12 Participants | 25 Participants |
| Sex: Female, Male Male | 37 Participants | 38 Participants | 75 Participants |
| surgical history negative | 28 Participants | 34 Participants | 62 Participants |
| surgical history positive | 22 Participants | 16 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 8 / 50 | 23 / 50 |
| other Total, other adverse events | 14 / 50 | 19 / 50 |
| serious Total, serious adverse events | 27 / 50 | 35 / 50 |
Outcome results
Primary
Number of Participants Who Died by Day 28
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.
Time frame: 28 days after ICU admission
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low CLI equal or less than 85.55 cutoff point. | Number of Participants Who Died by Day 28 | 8 Participants |
| High CLI greater than 85.55 cutoff point. | Number of Participants Who Died by Day 28 | 23 Participants |
p-value: 0.001Chi-squared
Secondary
ICU Stay [Unit: More Than 3 Days].
ICU Stay \[Unit: more than 3 Days\].
Time frame: up to 28 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Low CLI equal or less than 85.55 cutoff point. | ICU Stay [Unit: More Than 3 Days]. | 7.96 days |
| High CLI greater than 85.55 cutoff point. | ICU Stay [Unit: More Than 3 Days]. | 8.78 days |
p-value: 0.24395% CI: [-0.567, 2.207]t-test, 2 sided
Secondary
Procalcitonin [Unit: ng/mL] [Time Frame: 3 Days]
The Relationship Between Variables: The investigators will analyze CLI as a prognostic indicator using logistic regression to predict risk of ICU mortality.
Time frame: up to 3 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low CLI equal or less than 85.55 cutoff point. | Procalcitonin [Unit: ng/mL] [Time Frame: 3 Days] | 8.65 ng/ml | Standard Deviation 16.55 |
| High CLI greater than 85.55 cutoff point. | Procalcitonin [Unit: ng/mL] [Time Frame: 3 Days] | 16.62 ng/ml | Standard Deviation 20.63 |
p-value: 0.03795% CI: [0.54, 15.4]t-test, 2 sided