跳至主要内容
临床试验/CTRI/2024/03/064273
CTRI/2024/03/064273招募中不适用

Acute hemodynamiC response To Carvedilol predicts survival in ACLF patients –“ACT - C ACLF study”

Institute of Liver and Biliary Sciences1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年3月26日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Predictive value of acute HVPG change by carvedilol for 28 day transplant free survival in patients of ACLF

研究概览

简要总结

Clinically significant portal hypertension (CSPH) is defined asHVPG >10 mmHg. Patients with CSPH are at risk of developing esophageal varices and clinical decompensation (variceal bleeding, ascites,jaundice, encephalopathy), which mark the transition from compensated stage to a stage of the disease (decompensated) associated with higher mortality(1). HVPG is calculated by subtracting the free hepatic venous pressure (FHVP), a measure of systemic pressure, from the wedged hepatic venous pressure (WHVP), a measure of hepatic sinusoidal pressure. HVPG is surrogate marker in many clinical applications such as gold standard test to evaluate presence and severity of portal hypertension (PHT) diagnosis, risk stratification, monitoring of the patients on beta blockers(2).  Non selective beta-blockers like propranolol and carvedilol are indicated in adults for primary and secondary prophylaxis of varicealhemorrhage. Acute hemodynamic response to intravenous propranolol with HVPG values coming down to <12 mm Hg or reduction to >20% from baseline have been shown to be associated with reduced long term risk of variceal bleed.Hence we are planning the current work to study the Acute hemodynamiC response To Carvedilol predicts survival in ACLF patients – “ACT - C ACLF study.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Age 18–70 yrs
  • ACLF diagnosis (AARC criteria).

排除标准

  • Contraindications to NSBB (Heart rate less than 65 per min, BP less than 110 by 65 mm Hg, Asthma, Heart failure, AKI, Large ascites, SBP, S.
  • Na less than 125)
  • HE grades 2 to 4
  • NSBB therapy within 5 days
  • Pregnancy
  • Lactation
  • Planned for LT in the next 12 weeks
  • No consent.

结局指标

主要结局

Predictive value of acute HVPG change by carvedilol for 28 day transplant free survival in patients of ACLF

时间窗: Day 28

次要结局

  • Complications [PHT related bleed, AKI, infections, HE, Hypotension, Cardiac side effect] within 90 days(90 days)
  • Transplant-free survival rate at 90 days(90 days)
  • Correlation with evolution of AARC score by 2 weeks(2 weeks)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Garvit Mundra

Institute of Liver and Biliary Sciences

研究点 (1)

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