NCT04208776

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

Completed NA Last updated 20 March 2024

What this trial tests

NA trial testing Propranolol in Decompensated Cirrhosis in 140 participants. Completed in 31 December 2021.

Timeline

4 February 2020

Primary endpoint
31 December 2021

31 December 2021

Quick facts

Lead sponsor	Institute of Liver and Biliary Sciences, India
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	140
Start date	4 February 2020
Primary completion	31 December 2021
Estimated completion	31 December 2021
Sites	1 location across India

Drugs / interventions tested

• Propranolol (propranolol) — full drug profile →
• Midodrine — full drug profile →

Conditions studied

• Decompensated Cirrhosis — all drugs for Decompensated Cirrhosis →
• Severe Ascites — all drugs for Severe Ascites →

Sponsor

Institute of Liver and Biliary Sciences, India

Who can join

18 and older, any sex, with Decompensated Cirrhosis or Severe Ascites. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.