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

Institute of Liver and Biliary Sciences, India

Status: Completed

Conditions: Cirrhosis

Treatments: Drug: Midodrine; Drug: Terlipressin; Drug: Albumin

Study type: Interventional

Funder types: Other

Identifiers

NCT03144713

ILBS-Cirrhosis-10

Details and patient eligibility

About

• 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)

Enrollment: 150 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Terlipressin

Experimental group

Description:

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)

Treatment:

Drug: Terlipressin

Midodrine

Active Comparator group

Description:

Midodrine 7.5 mg thrice daily for 3 days.

Treatment:

Drug: Midodrine

Standard Medical Therapy

Active Comparator group

Description:

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

Treatment:

Drug: Albumin