To Study the Safety and Efficacy of Midodrine With Albumin Versus Albumin Alone in Hepatic Hydrothorax- A Pilot Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Change in frequency of thoracentesis.
研究概览
简要总结
Hepatic hydrothorax is defined with accumulation of transudate fluid (500 ml) in the pleural cavity in patients with decompensated liver cirrhosis but without cardiopulmonary and pleural diseases. The Prevalence is 5-12% The treatment for hydrothorax is diuretics, repeated thoracocentensis, TIPS and liver transplant.. Midodrine increases effective arterial blood volume and also increases renal perfusion.It has also been used in Refractory ascitis .It has been shown to mobilise ascitis. In patients who are ineligible for TIPS and Liver transplant there is no data on Midodrine and its effects on Hydrothorax in cirrhotics.There are also no guidelines on the use of albumin during Pleural fluid tapping and the dose to be used. This study is being done to assess the safety and efficacy of Midodrine in hydrothorax.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with hepatic hydrothorax
- •Patients with age from 18-75 years
- •No evidence of Cardiac and pulmonary disease
排除标准
- •Renal failure ( Creatinine>2.5mg/dl)
- •Gastrointestinal bleeding
- •Spontaneous bacterial empyema/ Peritonitis
- •Patients with urinary retention
- •Intrinsic advanced pulmonary disease (CXR, HRCT thorax)
- •Cardiovascular disease (Electrocardiogram, 2D Echo)
- •Systemic arterial hypertension
- •Presence of hepatocellular carcinoma or portal vein thrombosis, Budd chiari syndrome
- •Patients with active untreated sepsis
- •Pregnancy
- •Patients with hepatic encephalopathy
- •Patients eligible for TIPS
- •No use of drugs affecting systemic hemodynamics prior to 7 day of enrollment
研究组 & 干预措施
Midodrine
Midodrine (5 mg TDS) along with albumin(20g/l) and diuretics. The dose of Midodrine will titrated according to the Mean arterial pressure (75-90mmhg). The dose will be increased to a maximum of 12.5 mg thrice daily.
干预措施: Albumin (Biological)
Albumin with diuretics
Albumin(20g/l) and diuretics.
干预措施: Albumin (Biological)
Midodrine
Midodrine (5 mg TDS) along with albumin(20g/l) and diuretics. The dose of Midodrine will titrated according to the Mean arterial pressure (75-90mmhg). The dose will be increased to a maximum of 12.5 mg thrice daily.
干预措施: Midodrine (Drug)
Midodrine
Midodrine (5 mg TDS) along with albumin(20g/l) and diuretics. The dose of Midodrine will titrated according to the Mean arterial pressure (75-90mmhg). The dose will be increased to a maximum of 12.5 mg thrice daily.
干预措施: Diuretics (Drug)
Albumin with diuretics
Albumin(20g/l) and diuretics.
干预措施: Diuretics (Drug)
结局指标
主要结局
Change in frequency of thoracentesis.
时间窗: 3 months
次要结局
- Development of Spontaneous Bacterial Empyema(3 Months)
- Number of patients going for TIPS(Transintrahepatic Portosystemic Shunts)(3 Months)
- Partial or complete resolution of hepatic hydrothorax(3 months)
- Development of Thorocacocentesis Induced circulatory dysfunction(3 Months)
- Drug related adverse events in both arms(3 Months)
- Transplant free survival in both groups(3 Months)
- Predictors and mechanisms of repeated development of hepatic hydrothorax(3 Months)