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临床试验/NCT05879445
NCT05879445尚未招募不适用

Causes, Complications and Outcomes of Severe Acute Liver Disease Cases Admitted to Intensive Care Units

Assiut University0 个研究点目标入组 200 人开始时间: 2023年6月20日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
主要终点
Assessment of Liver function in individuals with ALF admitted to intensive care unit.

研究概览

简要总结

Acute liver failure (ALF) is a potentially fatal complication of severe hepatic illness resulting from various causes. In a clinical setting, severe hepatic injury is usually recognized by the appearance of jaundice, encephalopathy and coagulopathy.

The term acute liver failure (ALF) is frequently applied as a generic expression to describe patients presenting with or developing an acute episode of liver dysfunction.

Cerebral edema is very common in patients with acute liver failure and encephalopathy.

Acute liver failure (ALF) has Less common aetiologies include viral hepatitis, drug-induced liver injury, pregnancy-induced liver failure and autoimmune hepatitis.

Survival for patients with ALF has steadily improved over the last few decades. Acute liver failure (ALF) is defined as sever acute liver injury with encephalopathy and impairment of synthetic function (INR ˃1.5) in a patient without pre-existing cirrhosis or liver disease.

Acute liver failure (ALF) and acute on chronic liver Failure (ACLF) are conditions frequently encountered in the ICU and are associated with high mortality.

详细描述

The main objectives of this observational study are:

  1. To evaluate cases of (ALF) and (ACLF) according to guidelines.
  2. To determine most likely causes of disease in a patient of each age.
  3. To determine complications of disease.
  4. Assesment of mortality and morbidity rates.
  5. Assessment of in-hospital and six month follow up outcomes according to guidelines.

Participants (or their designated contact persons) will be contacted over the phone for either a telephone interview or a follow-up visit in the outpatient clinics, whichever feasible and possible.

All patients presented with severe acute liver disease, acute liver failure (ALF) and acute on chronic liver disease (ACLF).

  1. Inclusion criteria:

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • reduced conscious state
  • Jaundice with abnormal liver function tests, especially elevations in amino acid transferase levels more than 25 times the upper limit of normal
  • Coagulopathy
  • Multiorgan failure

排除标准

  • Patients with known cardiac cirrhosis.
  • Patients with known pre-existing renal disease

结局指标

主要结局

Assessment of Liver function in individuals with ALF admitted to intensive care unit.

时间窗: 2 weeks after admission to intensive care unit

Measuring serum alanine transaminase (ALT) level, serum aspartate transaminase (AST) level, serum alkaline phosphatase (ALP) level, serum gamma-glutamyl transferase (GGT) level.

Assessment of fluid overload in individuals with ALF admitted to intensive care unit.

时间窗: 2 weeks after admission to intensive care unit

Measuring body weight.

Assessment of kidney function in individuals with ALF admitted to intensive care unit.

时间窗: 2 weeks after admission to intensive care unit

Measuring serum creatinine level

次要结局

  • Mortality rates(2 weeks after admission to intensive care unit)
  • Morbidity rates(2 weeks after admission to intensive care unit)

研究者

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

Abdallah Hussein Kamel Ibrahim

Resident Physician

Assiut University

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