Acute hemodynamiC response To Carvedilol predicts survival in ACLF patients –“ACT - C ACLF studyâ€
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
Dr Garvit Mundra
Institute of Liver and Biliary Sciences
