Efficacy of Combination of Midodrine With Propranolol in Preventing First Bleed in Decompensated Cirrhotics With Severe Ascites.

NCT04208776 | Completed

• 1 other identifier: ILBS-Cirrhosis-27
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Study population: Decompensated cirrhotics requiring primary prophylaxis with asciteswho are admitted to and attending the OPD at ILBS. Study Design : A Randomized controlled trial Study period : August 2019 to December 2020 (1.5 Years) Intervention : Treatment naïve patients will be given Propranolol and dose will be titrated every 2ndday to attain a target heart rate of 55. One group patients will be given maximum tolerated dose of propranolol with initial dosage of 20mg once a day and uptitrating every 2nd day by 20 mg.The patients who bleed will undergo EVL session. To the other group Midodine will be added to Propranolol.It will be started at 2.5mg TDS and will be uptitrated every 2nd day to a max of 10mg TDS to attain a MAP of atleast 70mm Hg and then uptitate the beta blocker simulataneously to attain the target heart rate. The patients who bleed will undergo EVL session. Monitoring and assessment : The patient will be monitored every day. The patient will undergo physical examination, complete blood counts, at baseline, LFT, KFT, at every 2nd day and day 7 from the start of therapy. Adverse effects : Bradycardia and hypotension due to beta blockers Stopping rule : Severe hyponatraemia (\<125), low mean arterial pressure(\<65) or cardiac output and increasing serum creatinine(\>1.5) identifies more vulnerable patients among those with decompensated cirrhosis, in whom a dose reduction or temporal discontinuation of NSBB treatment will be considered.

Conditions

Decompensated Cirrhosis; Severe Ascites

Outcome Measures

Primary Outcomes (1)

• Primary prevention of first variceal bleed in both groups

  prevention of first variceal bleed is based on clinicallly

  1 year

Secondary Outcomes (17)

• Achievement of target heart rate (THR) of 55-60 or reduction by 25 % from baseline

  Day 7

• HVPG reduction in both groups

  Day 90

• Survival in both groups

  1 year

• Incidence of therapeutic paracentesis in both groups

  Day 30

• Incidence of therapeutic paracentesis in both groups

  Day 90

Study Arms (2)

Midodrine+Propranolol

EXPERIMENTAL

Drug: Propranolol; Drug: Midodrine

Propranolol

ACTIVE COMPARATOR

Drug: Propranolol

Interventions

Propranolol DRUG

maximum tolerated dose of propranolol with initial dosage of 20mg once a day and uptitrating every 2nd day by 20 mg.

Midodrine+Propranolol; Propranolol

Midodrine DRUG

It will be started at 2.5mg TDS and will be uptitrated every 2nd day to a max of 10mg TDS to attain a MAP of atleast 70mm Hg and then uptitate the beta blocker simulataneously to attain the target heart rate

Midodrine+Propranolol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Decompensated Child C cirrhotics with grade II-III requiring primary prophylaxis

You may not qualify if:

• Spontaneous bacterial peritonitis
• Hepatic Encephalopathy
• Acute renal failure (S.Cr\>1.5)
• Hepatorenal syndrome
• Hypertension
• Coronary Artery Disease ; H/o arrhythmias, heart block
• Urinary retention
• Pheochromocytoma/thyrotoxicosis
• Coronary Obstructive Pulmonary Disease
• Hepatocellular Carcinoma
• Pregnancy
• Portal vein Thrombosis

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver and Biliary Sciences

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

Location

MeSH Terms

Conditions

Ascites

Interventions

Propranolol; Midodrine

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Ethanolamines

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: December 12, 2019
• First Posted: December 23, 2019
• Study Start: February 4, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)