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临床试验/NCT07642076
NCT07642076招募中4 期

Evaluation of the Clinical Impact of Adjunctive L-carnitine Therapy in Critically Ill Hepatic Patients Admitted to Intensive Care Unit

Beni-Suef University1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2026年6月15日最近更新:
适应症
干预措施
相关药物

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

Active Comparator

l carnitine

干预措施: Standard medical treatment (Drug)

control group

Active Comparator

干预措施: Standard medical treatment (Drug)

test group

Active Comparator

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

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

Ayten Amr Abd El-monem

Principal Investigator

Beni-Suef University

研究点 (1)

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