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

Primary Purpose

Cirrhosis

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Terlipressin
Midodrine
Albumin
Sponsored by
Institute of Liver and Biliary Sciences, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cirrhosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Institute of Liver and Biliary Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Terlipressin

Midodrine

Standard Medical Therapy

Arm 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)

Midodrine 7.5 mg thrice daily for 3 days.

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

Outcomes

Primary Outcome Measures

Incidence of Paracentesis Induced Circulatory Dysfunction (PICD).

Secondary Outcome Measures

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

Full Information

First Posted
May 5, 2017
Last Updated
September 1, 2018
Sponsor
Institute of Liver and Biliary Sciences, India
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1. Study Identification

Unique Protocol Identification Number
NCT03144713
Brief Title
Efficacy and Safety of Terlipressin With Albumin Versus Midodrine With Albumin Versus Albumin Alone in Prevention of Paracentesis Induced Circulatory Dysfunction in Cirrhosis
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
May 28, 2017 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
April 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Terlipressin
Arm Type
Experimental
Arm 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)
Arm Title
Midodrine
Arm Type
Active Comparator
Arm Description
Midodrine 7.5 mg thrice daily for 3 days.
Arm Title
Standard Medical Therapy
Arm Type
Active Comparator
Arm Description
Albumin-8g/L of tap- one half of dose at beginning of tap and rest half after 6 hours of tapping.
Intervention Type
Drug
Intervention Name(s)
Terlipressin
Intervention 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)
Intervention Type
Drug
Intervention Name(s)
Midodrine
Intervention 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)
Intervention Type
Drug
Intervention Name(s)
Albumin
Intervention Description
Albumin-8g/L of tap- one half of dose at beginning of tap and rest half after 6 hours of tapping.
Primary Outcome Measure Information:
Title
Incidence of Paracentesis Induced Circulatory Dysfunction (PICD).
Time Frame
Day 6
Secondary Outcome Measure Information:
Title
Number of hospital admission withing 28 days in all the 3 groups
Time Frame
28 days
Title
Development of Hyponatremia in all the 3 groups
Description
Hyponatremia is defined as S.Na < 130 meq/dL.
Time Frame
Day 28
Title
Development of Hepatic Encephalopathy in all the 3 groups
Description
Hepatic Encephalopathy defined as West Haven Grade > 1
Time Frame
Day 28
Title
Recurrence of ascites in all the 3 groups
Time Frame
Day 28
Title
Development of Acute Kidney Injury in all the 3 groups
Description
Acute Kidney Injury is defined as increase S.Creatinine by more than 0.3 mg/dL
Time Frame
Day 28
Title
Survival in all the 3 groups
Time Frame
Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with cirrhosis who undergo Large volume paracentesis (> 5L) Patients with age from 18-75 years Exclusion Criteria: 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
Facility Information:
Facility Name
Institute of Liver and Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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