NCT03645642

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

September 30, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

June 25, 2020

Status Verified

November 1, 2019

Enrollment Period

3 months

First QC Date

August 22, 2018

Last Update Submit

June 23, 2020

Conditions

Hepatic Hydrothorax

Outcome Measures

Primary Outcomes (1)

  • Change in frequency of thoracentesis.

    3 months

Secondary Outcomes (7)

  • Partial or complete resolution of hepatic hydrothorax

    3 months

  • Development of Spontaneous Bacterial Empyema

    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

  • +2 more secondary outcomes

Study Arms (2)

Midodrine

EXPERIMENTAL

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.

Drug: MidodrineBiological: AlbuminDrug: Diuretics

Albumin with diuretics

ACTIVE COMPARATOR

Albumin(20g/l) and diuretics.

Biological: AlbuminDrug: Diuretics

Interventions

MidodrineDRUG

Midodrine 5 mg thrice daily

Midodrine
AlbuminBIOLOGICAL

Albumin 20g/l

Albumin with diureticsMidodrine
DiureticsDRUG

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

Albumin with diureticsMidodrine

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Liver and Biliary Sciences

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

Location

MeSH Terms

Interventions

MidodrineAlbuminsDiuretics

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesProteinsAmino Acids, Peptides, and ProteinsNatriuretic AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2018

First Posted

August 24, 2018

Study Start

September 30, 2018

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

June 25, 2020

Record last verified: 2019-11

Locations

IN(1)