TYPE 2 HEPATORENAL SYNDROME (Type2 HRS)

July 10, 2012 updated by: Arun Sharma, Postgraduate Institute of Medical Education and Research

NORADRENALINE VERSUS TERLIPRESSIN IN THE TREATMENT OF TYPE 2 HEPATORENAL SYNDROME:A RANDOMIZED STUDY

Various vasoconstrictors have shown promising results in the management of type 1 hepatorenal syndrome (HRS). However, there are very few studies on vasopressors in the management of type 2 HRS. Terlipressin has been used commonly; however it is costly and not available in some countries. In the present study, the investigators evaluated safety and efficacy of terlipressin and noradrenaline in the treatment of type 2 HRS

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Chandigarh, India, 160012
        • Postgraduate Institute of Medical Education and Research Chandigarh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Cirrhosis with ascites with serum creatinine more than 1.5 mg/dl and less than 2.5 mg/dl
  2. Absence of shock, fluid losses and treatment with nephrotoxic drug
  3. No improvement in renal function following diuretic withdrawal and plasma volume expansion
  4. No ultrasound evidence of renal parenchymal disease or obstructive uropathy 5.Absence of proteinuria more than 500 mg/24 hour

Exclusion Criteria:

  1. Patients with history of coronary artery disease
  2. Cardiomyopathy
  3. Ventricular arrhythmia
  4. Obstructive arterial disease of limbs -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Terlipressin and Type-2 HRS
Patients in group A received terlipressin as an intravenous bolus of 0.5 mg every 6 h. If a significant reduction in serum creatinine level (≥1 mg/dL) was not observed during 3-day period, the dose of terlipressin was increased in a stepwise fashion every 3 days to a maximum of 2 mg every 6 hour.
Drug: Noradrenaline
Patients in group B received a continuous infusion of noradrenaline at an initial dose of 0.5 mg/hour, designed to achieve an increase in mean arterial pressure (MAP) of at least 10mmHg or an increase in 4-h urine output to more than 200 mL. When one of these goals was not achieved, the noradrenaline dose increased every 4 hour in steps of 0.5 mg/hour, up to the maximum dose of 3 mg/hour
Drug: Terlipressin
Patients in group A received terlipressin as an intravenous bolus of 0.5 mg every 6 h. If a significant reduction in serum creatinine level (≥1 mg/dL) was not observed during 3-day period, the dose of terlipressin was increased in a stepwise fashion every 3 days to a maximum of 2 mg every 6 hour
ACTIVE_COMPARATOR: Noradrenaline and Type-2 HRS
Patients in group B received a continuous infusion of noradrenaline at an initial dose of 0.5 mg/hour, designed to achieve an increase in mean arterial pressure (MAP) of at least 10mmHg or an increase in 4-h urine output to more than 200 mL. When one of these goals was not achieved, the noradrenaline dose increased every 4 hour in steps of 0.5 mg/hour, up to the maximum dose of 3 mg/hour
Drug: Noradrenaline
Patients in group B received a continuous infusion of noradrenaline at an initial dose of 0.5 mg/hour, designed to achieve an increase in mean arterial pressure (MAP) of at least 10mmHg or an increase in 4-h urine output to more than 200 mL. When one of these goals was not achieved, the noradrenaline dose increased every 4 hour in steps of 0.5 mg/hour, up to the maximum dose of 3 mg/hour
Drug: Terlipressin
Patients in group A received terlipressin as an intravenous bolus of 0.5 mg every 6 h. If a significant reduction in serum creatinine level (≥1 mg/dL) was not observed during 3-day period, the dose of terlipressin was increased in a stepwise fashion every 3 days to a maximum of 2 mg every 6 hour

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary end point of the study was serum creatinine less than 1.5 mg
Time Frame: 15 days
15 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Secondary end points include death of patients
Time Frame: 15 days
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Postgraduate Institute of Medical Education and Research

Investigators

  • Principal Investigator: Virendra Singh, DM, Postgraduate Institute of Medical Education and Research, Chandigarh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

June 28, 2012

First Submitted That Met QC Criteria

July 10, 2012

First Posted (ESTIMATE)

July 11, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

July 11, 2012

Last Update Submitted That Met QC Criteria

July 10, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PGIMERIndia

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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