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

• Sponsor: Institute of Liver and Biliary Sciences, India (Other)
• Overall Status: Completed
• CT.gov ID: NCT03144713
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arms: 3
• Actual Duration (Months): 11.1
• Patients Per Site Per Month: 13.5

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Cirrhosis	Drug: Terlipressin; Drug: Midodrine; Drug: Albumin	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized Trial Comparing the Efficacy and Safety of Terlipressin With Albumin Versus Midodrine With Albumin Versus Albumin Alone in Prevention of Paracentesis Induced Circulatory Dysfunction in Cirrhosis
• Actual Study Start Date: May 28, 2017
• Actual Primary Completion Date: Apr 30, 2018
• Actual Study Completion Date: Apr 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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)	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)
Active Comparator: Midodrine Midodrine 7.5 mg thrice daily for 3 days.	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)
Active Comparator: Standard Medical Therapy Albumin-8g/L of tap- one half of dose at beginning of tap and rest half after 6 hours of tapping.	Drug: Albumin; Albumin-8g/L of tap- one half of dose at beginning of tap and rest half after 6 hours of tapping.

Outcome Measures

Primary Outcome Measures

1. Incidence of Paracentesis Induced Circulatory Dysfunction (PICD). [Day 6]

Secondary Outcome Measures

1. Number of hospital admission withing 28 days in all the 3 groups [28 days]

2. Development of Hyponatremia in all the 3 groups [Day 28]

   Hyponatremia is defined as S.Na < 130 meq/dL.

3. Development of Hepatic Encephalopathy in all the 3 groups [Day 28]

   Hepatic Encephalopathy defined as West Haven Grade > 1

4. Recurrence of ascites in all the 3 groups [Day 28]

5. 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

6. Survival in all the 3 groups [Day 28]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Liver and Biliary Sciences	New Delhi	Delhi	India	110070

Sponsors and Collaborators

• Institute of Liver and Biliary Sciences, India

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Institute of Liver and Biliary Sciences, India
• ClinicalTrials.gov Identifier: NCT03144713
• Other Study ID Numbers: ILBS-Cirrhosis-10
• First Posted: May 9, 2017
• Last Update Posted: Sep 5, 2018
• Last Verified: May 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Liver Cirrhosis; Fibrosis; Terlipressin; Midodrine

Study Results

No Results Posted as of Sep 5, 2018