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OpenTrials
Completed

NCT Number: NCT03645642

To Study the Safety and Efficacy of Midodrine With Albumin Versus Albumin Alone in Hepatic Hydrothorax

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.

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Key information

Conditions

Hepatic Hydrothorax

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with hepatic hydrothorax
  • Patients with age from 18-75 years
  • No evidence of Cardiac and pulmonary disease

Exclusion criteria

  • 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

Treatment and study plan

Midodrine

Drug

Midodrine 5 mg thrice daily

Albumin

Biological

Albumin 20g/l

Diuretics

Drug

Diuretics will be continued with an maximum dose of furosemide (160mg) and Aldactone 400 mg.

Primary outcomes

  1. Change in frequency of thoracentesis.

    Time frame: 3 months

Secondary outcomes

  1. Partial or complete resolution of hepatic hydrothorax

    Time frame: 3 months

  2. Development of Spontaneous Bacterial Empyema

    Time frame: 3 Months

  3. Development of Thorocacocentesis Induced circulatory dysfunction

    Time frame: 3 Months

  4. Drug related adverse events in both arms

    Time frame: 3 Months

  5. Transplant free survival in both groups

    Time frame: 3 Months

  6. Predictors and mechanisms of repeated development of hepatic hydrothorax

    Time frame: 3 Months

  7. Number of patients going for TIPS(Transintrahepatic Portosystemic Shunts)

    Time frame: 3 Months

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Official study title

To Study the Safety and Efficacy of Midodrine With Albumin Versus Albumin Alone in Hepatic Hydrothorax- A Pilot Randomised Controlled Trial

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 24, 2018
Registry last updated
Jun 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.