Efficacy and Safety of Terlipressin With Albumin Versus Midodrine With Albumin Versus Albumin Alone in Prevention of Paracentesis Induced Circulatory Dysfunction in Cirrhosis

NCT03144713 | Completed

• 1 other identifier: ILBS-Cirrhosis-10
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Incidence of Paracentesis Induced Circulatory Dysfunction (PICD).

  Day 6

Secondary Outcomes (6)

• Number of hospital admission withing 28 days in all the 3 groups

  28 days

• Development of Hyponatremia in all the 3 groups

  Day 28

• Development of Hepatic Encephalopathy in all the 3 groups

  Day 28

• Recurrence of ascites in all the 3 groups

  Day 28

• Development of Acute Kidney Injury in all the 3 groups

  Day 28

Study Arms (3)

Terlipressin

EXPERIMENTAL

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: Terlipressin

Midodrine

ACTIVE COMPARATOR

Midodrine 7.5 mg thrice daily for 3 days.

Drug: Midodrine

Standard Medical Therapy

ACTIVE COMPARATOR

Albumin-8g/L of tap- one half of dose at beginning of tap and rest half after 6 hours of tapping.

Drug: Albumin

Interventions

Terlipressin DRUG

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)

Terlipressin

Midodrine DRUG

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)

Midodrine

Albumin DRUG

Albumin-8g/L of tap- one half of dose at beginning of tap and rest half after 6 hours of tapping.

Standard Medical Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with cirrhosis who undergo Large volume paracentesis (\> 5L)
• Patients with age from 18-75 years

You may not qualify if:

• 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
• Patients with active untreated sepsis
• Pregnancy
• Patients with hepatic encephalopathy
• No use of drugs affecting systemic hemodynamic 3 days prior to enrollment
• Refusal to participate

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

Fibrosis

Interventions

Terlipressin; Midodrine; Albumins

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lypressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

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: May 5, 2017
• First Posted: May 9, 2017
• Study Start: May 28, 2017
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: September 5, 2018

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)