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临床试验/NCT06298656
NCT06298656尚未招募不适用

Acute hemodynamiC Response To Carvedilol Predicts Survival in ACLF Patients - "ACT - C ACLF Study

Institute of Liver and Biliary Sciences, India1 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10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
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 as HVPG >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 variceal hemorrhage. 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

详细描述

To assess whether Acute hemodynamic response to oral Carvedilol can predict short term outcome in ACLF patients.

• To determine the best cut off to define acute hemodynamic response in ACLF patients

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

Secondary outcome -

(1) Complications [PHT related bleed, AKI, infections, HE, Hypotension, Cardiac side effect] within 90 days (2) Transplant-free survival rate at 90 days (3) Correlation with evolution of AARC score by 2 week

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

入选标准

  • Age 18-70 yrs
  • ACLF diagnosis (AARC criteria)

排除标准

  • Contraindications to NSBB (Heart rate < 65 /min, BP < 110/65 mm Hg, Asthma, Heart failure, AKI, Large ascites, SBP, S. Na < 125meq/l)
  • HE grades 2-4
  • NSBB therapy within 5 days
  • 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: 28 days

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 week(2 week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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