DRUG
Terlipressin
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)
Efficacy and Safety of Terlipressin With Albumin Versus Midodrine With Albumin Versus Albumin Alone in Prevention of Paracentesis Induced Circulatory Dysfunction in Cirrhosis
Status
Completed
Phase
Not applicable
Enrollment
150
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
* 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)
Interventions
Treatment arms and agents.
DRUG
Midodrine
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)
DRUG
Albumin
Albumin-8g/L of tap- one half of dose at beginning of tap and rest half after 6 hours of tapping.
Timeline
From registration to results.
First posted
May 9, 2017
Study start
May 28, 2017
Primary completion
Apr 30, 2018
Study completion
Apr 30, 2018
Results posted
Not reported
Registry updated
Sep 5, 2018
Outcomes
What the study measures.
Primary outcomes
Incidence of Paracentesis Induced Circulatory Dysfunction (PICD).
Time frame · Day 6
Secondary outcomes
Number of hospital admission withing 28 days in all the 3 groups
Time frame · 28 days
Development of Hyponatremia in all the 3 groups
Time frame · Day 28
Hyponatremia is defined as S.Na \< 130 meq/dL.
Development of Hepatic Encephalopathy in all the 3 groups
Time frame · Day 28
Hepatic Encephalopathy defined as West Haven Grade \> 1
Recurrence of ascites in all the 3 groups
Time frame · Day 28
Development of Acute Kidney Injury in all the 3 groups
Time frame · Day 28
Acute Kidney Injury is defined as increase S.Creatinine by more than 0.3 mg/dL
Survival in all the 3 groups
Time frame · Day 28
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients with cirrhosis who undergo Large volume paracentesis (\> 5L) 2. Patients with age from 18-75 years Exclusion Criteria: 1. Renal failure ( Creatinine\>1.5mg/dl) 2. Recent Gastrointestinal bleeding within 7 days 3. Spontaneous bacterial Peritonitis 4. Patients with Cardiovascular disease (Electrocardiogram, 2D Echo) 5. Systemic arterial hypertension ( \>160/90mmhg) Presence of hepatocellular carcinoma or portal vein thrombosis, Budd chiari syndrome 6. Patients with active untreated sepsis 7. Pregnancy 8. Patients with hepatic encephalopathy 9. No use of drugs affecting systemic hemodynamic 3 days prior to enrollment 10. Refusal to participate
Study locations
1 registered sites.
India. Showing up to 24 locations stored in the fast local snapshot.
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Terlipressin.
NCT IDStudyPhase / statusEnrollmentUpdated
Intraoperative Continuous Terlipressin Infusion is Associated With Reduced Severe Postoperative Complications After Laparoscopic Hepatectomy: a Prospective Propensity Score-matched Cohort Study
First Affiliated Hospital, Sun Yat-Sen University · Liver Neoplasms · Postoperative Complications
Not applicable
Completed
161
2026-07
Efficacy Of Bovine Colostrum In The Treatment Of Severe Alcohol-Associated Hepatitis: A Randomized Controlled Trial
Dayanand Medical College and Hospital · Alcoholic Hepatitis
Phase 3
Active, not recruiting
174
2026-07
Effect of Terlipressin for Intraoperative Blood Pressure Management in Kidney Transplantation
Beijing Friendship Hospital · Kidney Transplant · Delayed Graft Function
Not applicable
Active, not recruiting
150
2026-07
Interest of in Situ Terlipressin Administration Before the Realisation of Bronchial Biopsy
University Hospital, Rouen · Bronchial Endoscopy
Phase 3
Completed
130
2026-06
Effects of Terlipressin and Somatostatin on Portal Pressure in Patients Undergoing Living Donor Liver Transplantation
Istanbul Medipol University Hospital · Liver Transplantation · Portal Hypertension
Not applicable
Recruiting
50
2026-04
ACid Tranexamic or Terlipressin for Initial Emergency Treatment of Mild to seVere hEmoptysis: a Randomized Trial.
Assistance Publique - Hôpitaux de Paris · Hemoptysis
Phase 3
Completed
315
2026-04
Endothelin Receptor Antagonism With Ambrisentan to Treat Hepatorenal Syndrome
Noorik Biopharmaceuticals AG · Hepatorenal Syndrome · Liver Cirrhosis
Phase 2
Active, not recruiting
54
2026-04
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Institute of Liver and Biliary Sciences, India · Acute-on-Chronic Liver Failure (ACLF)
Not applicable
Not yet recruiting
56
2026-03
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.