跳至主要内容
临床试验/NCT05566548
NCT05566548招募中不适用

The Importance of Bilirubin Molecular Species in Patients With Liver Cirrhosis Who Develop Hepatic Encephalopathy and Patients With Acute-on-chronic Liver Failure

Medica Sur Clinic & Foundation1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
Identify levels of Conjugated Bilirubin as Bilirubin monoglucuronide (BMG), bilirubin diglucuronide (BDG) and unconjugated bilirubin (UCB) in patients with acute-on-chronic liver failure

研究概览

简要总结

It has been identified that impaired liver function, as occurs in patients with liver cirrhosis, prevents proper conjugation of glucuronic acid with bilirubin; as a result, unconjugated bilirubin accumulates in the blood, and conjugated bilirubin is markedly altered to form diglucuronides or monoglucuronides. However, in the development and progress of acute-on-chronic liver failure (ACLF) there is not enough information about these processes and the possible concentration levels that they can take.

Also Hepatic encephalopathy (HE) is a reversible complication, but with a high mortality rate in patients with acute or chronic liver failure, as well as a consequence of the formation of portosystemic shunts.

详细描述

Liver cirrhosis is a pathological diagnosis characterized by diffuse fibrosis, severe alteration of intrahepatic arterial and venous flow, portal hypertension, and, ultimately, liver failure. The prevalence of liver cirrhosis in the Mexican population depends on various factors, including gender, ethnic groups, and geographic regions, in addition to the nature, frequency, and time of acquisition of the main risk factors for cirrhosis, such as the hepatitis B virus, hepatitis C virus (HCV) in addition to non-alcoholic steatohepatitis, non-alcoholic fatty liver or alcoholic liver disease. Liver cirrhosis has been classified as decompensated or compensated. Decompensated liver cirrhosis occurs when there is gradual progression over months causing liver and extrahepatic organ failure. On the other hand, if it appears suddenly, in a short-term deterioration for days or several weeks after the defined triggering disease, it is known as Acute-on-chronic liver failure (ACLF). ACLF is a syndrome characterized by acute and severe liver abnormalities as a result of different types of lesions present in patients with underlying chronic liver disease or cirrhosis, but unlike decompensated cirrhosis, it has a high short-term mortality.

It is important to determine the prognosis of patients with ACLF, in a short period of time, in order to act appropriately and reduce the use of temporary liver support or liver transplantation, an important variable that is included in various scores that assess liver function in different scenarios such as the Child-Pugh score and Model for End-stage Liver Disease (MELD) systems.

Among liver cirrhosis complications, there is the Hepatic encephalopathy (HE) involves a wide range of neurocognitive and psychiatric abnormalities that can range from subclinical neurological deficits and disturbances in attention to coma. Diagnosis of hepatic encephalopathy can be made using the West Haven (WH) criteria, which are clinical criteria that evaluate the degree of neurological deterioration and divide hepatic encephalopathy into 5 grades (from grade 0 to grade 4), with grades 3 and 4 having a worse prognosis. In addition to these criteria, it can be diagnose based on psychometric tests such as the Portosystemic- Encephalopathy- Syndrome test (PSE) and psychophysiological tests, such as the Critical flicker frequency (CFF). Despite the existence of this evidence and the WH criteria, there is no quantitative parameter that can be used to diagnose the hepatic encephalopathy. In addition, although the quantification of ammonia levels is carried out in multiple centers as part of the protocol for diagnosing HE, there are numerous studies showing that ammonia levels cannot be used to diagnose or rule out the presence of HE.

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
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with Acute-on-chronic liver failure (ACLF)
  • Patients hepatic encephalopathy (HE)
  • Any etiology of liver cirrhosis alcoholic liver disease (ALD), HCV, liver disease fatty liver associated with metabolism dysfunction (MAFLD) and diseases autoimmune liver
  • With or without the existence of any precipitating event or medical complication: infection acute bacterial, consumption hepatitis severe alcoholic, variceal bleeding, drug-induced encephalopathy, ascites, coagulopathy, sepsis
  • Any ACLF grade
  • Any HE grade

排除标准

  • Immunodeficiency virus infection human (HIV)
  • Cholestatic liver disease,
  • Past or current extrahepatic malignant tumor,
  • Liver transplant,
  • Other serious concomitant diseases heart, lung, kidney, or other organs
  • Patients with metastatic hepatocellular carcinoma (HCC)

结局指标

主要结局

Identify levels of Conjugated Bilirubin as Bilirubin monoglucuronide (BMG), bilirubin diglucuronide (BDG) and unconjugated bilirubin (UCB) in patients with acute-on-chronic liver failure

时间窗: The serum sample will be taken at the moment of the first patient physician contact (admission, medical visit). The bilirubin measure will be done 24 hours after

Identification and measured concentration of bilirubin molecular species through liquid chromatography-mass spectrometry (LC-MS)

次要结局

  • Comparison of the bilirubin levels of the different groups(It will be analyzed when all the results from the LC-MS are done. Approximately 5 months.)

研究者

发起方
Medica Sur Clinic & Foundation
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nahum Méndez-Sánchez

Principal investigator

Medica Sur Clinic & Foundation

研究点 (1)

Loading locations...

相似试验