Efficacy and Safety of Terlipressin With Albumin Versus Midodrine With Albumin Versus Albumin Alo… (NCT03144713) | Clinical Trial Compass
CompletedNot Applicable
Efficacy and Safety of Terlipressin With Albumin Versus Midodrine With Albumin Versus Albumin Alone in Prevention of Paracentesis Induced Circulatory Dysfunction in Cirrhosis
India150 participantsStarted 2017-05-28
Plain-language summary
* Study Population: Patients admitted or seen in Out Patient Department, Department of Hepatology, Institute of Liver and Biliary Sciences.
* Study Design: Prospective Open Labeled Randomized Controlled Trial.
* Study Period: January 2017 to December 2017
* Intervention- Subjects will be randomized to 3 groups
* All patients will receive Standard medical therapy - Albumin-8g/L of tap- one half of dose at beginning of tap and rest half after 6 hours of tapping.
Group A - Subjects will receive Terlipressin 1mg intravenous bolus at the onset of paracentesis and the remaining as 1 mg doses intravenous at 8 and 16 h after the first dose. ( total -3mg) Group B - Midodrine 7.5 mg TDS x 3 days Group C - Standard medical therapy only
* Monitoring and Assessment: Clinical evaluation will be done at regular intervals.
* Adverse Effects: Rise in blood pressure, arrthymias, hyponatremia and rarely cardiovascular side effects have been noted.
* Stopping Rule: Development of PICD, hypertension ( BP\>160/90mmhg-JNC class II)
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients with cirrhosis who undergo Large volume paracentesis (\> 5L)
. Patients with age from 18-75 years
Exclusion criteria
. Renal failure ( Creatinine\>1.5mg/dl)
. Recent Gastrointestinal bleeding within 7 days
. Spontaneous bacterial Peritonitis
. Patients with Cardiovascular disease (Electrocardiogram, 2D Echo)
. Systemic arterial hypertension ( \>160/90mmhg) Presence of hepatocellular carcinoma or portal vein thrombosis, Budd chiari syndrome
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Paracentesis Induced Circulatory Dysfunction (PICD).
Timeframe: Day 6
Trial details
NCT IDNCT03144713
SponsorInstitute of Liver and Biliary Sciences, India