Clinical trial NCT06901544: Capillary Leak Index as a Prognostic Indicator for Post-Operative Abdominal Sepsis in Critically Ill Patients
Official title: Capillary Leak Index as a Prognostic Indicator for Post-Operative Abdominal Sepsis in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Intra-Abdominal Infections
Intestinal Obstruction
Appendicitis Acute
Perforated Viscus
Keywords: Capillary Leak Index
secondary abdominal sepsis
sepsis
Prognostic value
Good indicator
mortality
Intensive Care Unit
ICU
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-03-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ICU Patient Post operative abdominal sepesis

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Correlation between CLI and 28 days Mortality.
timeFrame: 28 days mortality
Secondary outcomes:
measure: 1: Procalcitonin [Unit: ng/mL] [Time Frame: 3 days] 2: ICU Stay [Unit: more than 3 Days].
timeFrame: 28 days mortality rate
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Surgical intensive Care Unit, Ain Shams University Hospitals.
Study officials:
affiliation: Ain shams University Faculty of medicine
name: Ahmed M Ahmed, MD.
role: STUDY_DIRECTOR
affiliation: Ain Shams University Faculty of medicine
name: Hanaa A El-Gendy, MD
role: STUDY_CHAIR
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