Evaluation of the Clinical Impact of Adjunctive L-carnitine Therapy in Critically Ill Hepatic Patients Admitted to Intensive Care Unit
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- laboratory value: international normalized ratio
研究概览
简要总结
This study aims to evaluate the possible efficacy of l-carnitine in critically ill hepatic patients admitted to intensive care unit.
详细描述
Decompensated cirrhosis is characterized by high hospitalization rates and costs, frequent readmissions, and poor short-term survival. Patients admitted to the hospital with acute variceal bleeding and/or hepatic encephalopathy are at serious risk for developing infection and/or sepsis; in turn, this renders them highly susceptible to the development of multi-system organ failure. The lack of standardized intensive care unit management protocols in patients with cirrhosis along with only few data reports from longitudinal clinical trials makes it difficult for hepatologists and critical care specialists to provide uniform evidence for clinical practice that could safely consolidate favorable outcomes such as lower hospitalization rates and/or mortality.
Decompensated cirrhosis is a common reason for admission to the acute medical unit, and such patients typically have complex medical needs and are at high risk of in-hospital death. It is therefore vital that these patients receive appropriate investigations and management as early as possible in their patient journey. Typical presenting clinical features include jaundice, ascites, hepatic encephalopathy, hepato-renal syndrome ,or variceal hemorrhages.
hepatic encephalopathy (HE) is defined as a brain dysfunction caused by liver insufficiency and/or portal-systemic blood shunting. It manifests as a wide spectrum of neurological or psychiatric abnormalities, ranging from subclinical alterations, detectable only by neuropsychological or neurophysiological assessment, to coma.
Hepatorenal syndrome (HRS) is a common complication of advanced cirrhosis, characterized by renal failure and major disturbances in circulatory function. Renal failure is caused by intense vasoconstriction of the renal circulation. The syndrome is probably the final consequence of extreme underfilling of the arterial circulation secondary to arterial vasodilatation in the splanchnic vascular bed. As well as the renal circulation, most extra splanchnic vascular beds are vasoconstricted.
Spontaneous bacterial peritonitis (SBP) is the most frequent and life-threatening infection in patients with liver cirrhosis requiring prompt recognition and treatment. It is defined by the presence of >250 polymorphonuclear cells (PMN)/mm3 in ascites in the absence of an intra-abdominal source of infection or malignancy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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 more than 18 years old
- •male or female with confirmed liver disease admitted to intensive care unit, including:
- •Acute-on-chronic liver failure (ACLF)
- •Hepatic encephalopathy
- •spontaneous bacterial peritonitis (SBP)
- •variceal bleeding
- •fulminant hepatitis
- •Hepatorenal syndrome
排除标准
- •Age of less than 18 years old
- •Pregnancy or Lactation
- •patients have seizure
- •patient on warfarin
研究组 & 干预措施
test group
l carnitine
干预措施: Standard medical treatment (Drug)
control group
干预措施: Standard medical treatment (Drug)
test group
l carnitine
干预措施: L Carnitine (Drug)
结局指标
主要结局
laboratory value: international normalized ratio
时间窗: At ICU admission and at ICU discharge, an average of 7 days
laboratory value: serum creatinine(SCr)
时间窗: At ICU admission and at ICU discharge, an average of 7 days
laboratory value: Blood urea nitrogen(BUN)
时间窗: At ICU admission and at ICU discharge, an average of 7 days
laboratory value: Albumin
时间窗: At ICU admission and at ICU discharge, an average of 7 days
laboratory value: Alanine aminotransferase(ALT)
时间窗: At ICU admission and at ICU discharge, an average of 7 days
laboratory value: Aspartate aminotransferase(AST)
时间窗: At ICU admission and at ICU discharge, an average of 7 days
次要结局
未报告次要终点
研究者
Ayten Amr Abd El-monem
Principal Investigator
Beni-Suef University
