NCT05180292招募中不适用
Acute Hemodynamic Response to Carvedilol in Predicting Survival in Acute on Chronic Liver Failure Patients - A Pilot Study.
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Liver transplant free survival
研究概览
简要总结
Various parameters will be assessed during the procedure before and after 1 hour of 12.5 mg carvedilol such as HVPG (WHVP - FHVP), SVR, heart rate, cardiac output, cardiac index, Blood pressure (systolic, diastolic and mean), SpO2. Routine treatment of the patients will be continued as per the Institute protocol. These patients will be assessed for the liver transplant free survival at 28 days and complications [PHT related bleed, AKI, infections, HE] within 90 days; transplant-free survival rate at 90 days; evolution of the AARC score for 2 wk.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 否
入选标准
- •Patients of ACLF (APASL criteria) - jaundice (serum bilirubin ≥ 5 mg/dL and coagulopathy (INR ≥ 1.5) complicated within 4 weeks by clinical ascites and/or encephalopathy in a patient with previously diagnosed or undiagnosed chronic liver disease/cirrhosis,
- •Age 18-70 yrs
- •Baseline HVPG ≥ 12 mmHg.
排除标准
- •Contraindications to NSBB (heart rate < 65 /min, BP < 110/65 mm Hg, asthma, heart failure),
- •Portal Vein Thrombosis,
- •Hepatocellular carcinoma,
- •HE grades 2-4,
- •NSBB therapy within 5 days,
- •Planned for LT in the next 12 weeks
- •No consent.
研究组 & 干预措施
Acute on Chronic Liver failure
Experimental
干预措施: Carvedilol 12.5 MG (Drug)
结局指标
主要结局
Liver transplant free survival
时间窗: Day 28
次要结局
- Complications [PHT related bleed, AKI, infections, HE] within 90 days(90 days)
- Liver transplant-free survival rate(90 days)
- Correlation with evolution of AARC score(2 weeks)
研究者
研究点 (1)
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