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

Not Applicable

Completed

• Conditions: Cirrhosis
• Interventions: Drug: Albumin; Drug: Terlipressin; Drug: Midodrine

• Registration Number: NCT03144713
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

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)

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-05
• Study First Submitted: 2017-05-05
• Study First Submitted QC: 2017-05-08
• Study First Posted: 2017-05-09
• Study Start: 2017-05-28
• Primary Completion: 2018-04-30
• Study Completion: 2018-04-30
• Last Update Submitted: 2018-09-01
• Last Update Posted: 2018-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Medical Therapy	Albumin	Albumin-8g/L of tap- one half of dose at beginning of tap and rest half after 6 hours of tapping.
Terlipressin	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)
Midodrine	Midodrine	Midodrine 7.5 mg thrice daily for 3 days.

Primary Outcome Measures

Name	Time	Method
Incidence of Paracentesis Induced Circulatory Dysfunction (PICD).	Day 6

Secondary Outcome Measures

Name	Time	Method
Number of hospital admission withing 28 days in all the 3 groups	28 days
Recurrence of ascites in all the 3 groups	Day 28
Development of Acute Kidney Injury in all the 3 groups	Day 28	Acute Kidney Injury is defined as increase S.Creatinine by more than 0.3 mg/dL
Survival in all the 3 groups	Day 28
Development of Hyponatremia in all the 3 groups	Day 28	Hyponatremia is defined as S.Na \< 130 meq/dL.
Development of Hepatic Encephalopathy in all the 3 groups	Day 28	Hepatic Encephalopathy defined as West Haven Grade \> 1

Trial Locations

Locations (1)

Institute of Liver and Biliary Sciences; 🇮🇳 New Delhi, Delhi, India