Efficacy of Combination of Midodrine With Propranolol in Preventing First Bleed in Decompensated Cirrhotics With Severe Ascites: A Randomized Controlled Trial"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Primary prevention of first variceal bleed in both groups
研究概览
简要总结
Study population: Decompensated cirrhotics requiring primary prophylaxis with asciteswho are admitted to and attending the OPD at ILBS.
Study Design : A Randomized controlled trial Study period : August 2019 to December 2020 (1.5 Years) Intervention : Treatment naïve patients will be given Propranolol and dose will be titrated every 2ndday to attain a target heart rate of 55.
One group patients will be given maximum tolerated dose of propranolol with initial dosage of 20mg once a day and uptitrating every 2nd day by 20 mg.The patients who bleed will undergo EVL session.
To the other group Midodine will be added to Propranolol.It will be started at 2.5mg TDS and will be uptitrated every 2nd day to a max of 10mg TDS to attain a MAP of atleast 70mm Hg and then uptitate the beta blocker simulataneously to attain the target heart rate. The patients who bleed will undergo EVL session.
Monitoring and assessment :
The patient will be monitored every day. The patient will undergo physical examination, complete blood counts, at baseline, LFT, KFT, at every 2nd day and day 7 from the start of therapy.
Adverse effects : Bradycardia and hypotension due to beta blockers Stopping rule : Severe hyponatraemia (<125), low mean arterial pressure(<65) or cardiac output and increasing serum creatinine(>1.5) identifies more vulnerable patients among those with decompensated cirrhosis, in whom a dose reduction or temporal discontinuation of NSBB treatment will be considered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Decompensated Child C cirrhotics with grade II-III requiring primary prophylaxis
排除标准
- •Spontaneous bacterial peritonitis
- •Hepatic Encephalopathy
- •Acute renal failure (S.Cr>1.5)
- •Hepatorenal syndrome
- •Hypertension
- •Coronary Artery Disease ; H/o arrhythmias, heart block
- •Urinary retention
- •Pheochromocytoma/thyrotoxicosis
- •Coronary Obstructive Pulmonary Disease
- •Hepatocellular Carcinoma
- •Portal vein Thrombosis
研究组 & 干预措施
Midodrine+Propranolol
干预措施: Propranolol (Drug)
Midodrine+Propranolol
干预措施: Midodrine (Drug)
Propranolol
干预措施: Propranolol (Drug)
结局指标
主要结局
Primary prevention of first variceal bleed in both groups
时间窗: 1 year
prevention of first variceal bleed is based on clinicallly
次要结局
- Paracentesis induced circulatory dysfunction(PICD) in both groups(1 year)
- Incidence of Acute Kidney Injury in both groups(1 year)
- Incidence of Variceal bleed in both groups(1 year)
- Achievement of target heart rate (THR) of 55-60 or reduction by 25 % from baseline(Day 7)
- Incidence of therapeutic paracentesis in both groups(Day 90)
- Incidence of Hyponatremia in both groups(1 year)
- Episodes of bacterial infection in both groups(1 year)
- HVPG reduction in both groups(Day 90)
- Survival in both groups(1 year)
- Incidence of decrease in ascites by at least one grade in both groups(3 months)
- Incidence of Hepatic Encephalopathy in both groups(1 year)
- Number of TIPS (TransIntrahepatic Portosystemic Shunt) procedure done in both groups(1 year)
- Number of patients who will receive diuretics in both groups(1 year)
- Incidence of Hepato Renal Syndrome in both groups(1 year)
- Adverse effects of drugs in both groups(1 year)
- Impact on portal, systemic and cardiac hemodynamics in both groups(1 year)