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临床试验/NCT06901544
NCT06901544已完成不适用

Capillary Leak Index as a Prognostic Indicator for Post-Operative Abdominal Sepsis in Critically Ill Patients

Ain Shams University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年3月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Number of Participants Who Died by Day 28

研究概览

简要总结

In this study the investigators going to evaluate the "CLI" as an early prognostic indicator for post-operative abdominal sepsis in critically ill patients.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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).

结局指标

主要结局

Number of Participants Who Died by Day 28

时间窗: 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.

次要结局

  • ICU Stay [Unit: More Than 3 Days].(up to 28 days)
  • Procalcitonin [Unit: ng/mL] [Time Frame: 3 Days](up to 3 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Osama Khalil

Principal Investigator

Ain Shams University

研究点 (1)

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