To Study the Safety and Efficacy of Midodrine With Albumin Versus Albumin Alone in Hepatic Hydrothorax
- Conditions
- Hepatic Hydrothorax
- Interventions
- Registration Number
- NCT03645642
- Lead Sponsor
- Institute of Liver and Biliary Sciences, India
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
- Patients with hepatic hydrothorax
- Patients with age from 18-75 years
- No evidence of Cardiac and pulmonary disease
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Albumin with diuretics Diuretics Albumin(20g/l) and diuretics. Midodrine Diuretics 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. Midodrine Albumin 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. Albumin with diuretics Albumin Albumin(20g/l) and diuretics. Midodrine 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.
- Primary Outcome Measures
Name Time Method Change in frequency of thoracentesis. 3 months
- Secondary Outcome Measures
Name Time Method 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 Development of Spontaneous Bacterial Empyema 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
Trial Locations
- Locations (1)
Institute of Liver and Biliary Sciences
🇮🇳New Delhi, Delhi, India