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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03645642

Enrollment

Registered

2018-08-24

Start date

2018-09-30

Completion date

2018-12-31

Last updated

2020-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Hydrothorax

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.

Interventions

DRUGMidodrine

Midodrine 5 mg thrice daily

BIOLOGICALAlbumin

Albumin 20g/l

DRUGDiuretics

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in frequency of thoracentesis.	3 months

Secondary

Measure	Time frame
Development of Spontaneous Bacterial Empyema	3 Months
Development of Thorocacocentesis Induced circulatory dysfunction	3 Months
Drug related adverse events in both arms	3 Months
Partial or complete resolution of hepatic hydrothorax	3 months
Predictors and mechanisms of repeated development of hepatic hydrothorax	3 Months
Number of patients going for TIPS(Transintrahepatic Portosystemic Shunts)	3 Months
Transplant free survival in both groups	3 Months

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026