To Compare The Efficacy Of N -Acetylcysteine and Standard Therapy Versus Standard Therapy In The Prevention Of Ischemic Hepatitis And Survival Post Upper GI Bleed

September 11, 2019 updated by: Institute of Liver and Biliary Sciences, India

TO COMPARE THE EFFICACY OF N -ACETYLCYSTEINE AND STANDARD THERAPY VERSUS STANDARD THERAPY IN THE PREVENTION OF ISCHEMIC HEPATITIS AND SURVIVAL POST UPPER GI BLEED

Patient presenting with upper GI bleed in ILBS (Institute of Liver and Biliary Sciences) emergency admitted to ICU (Intensive Care Unit) or shifted from ward to ICU (Intensive Care Unit) in view of upper GI bleed randomized to two groups

GROUP A : 110 Patients will receive standard care + NAC infusion for 72 hours

GROUP B : 110 Patients will receive standard care only

NAC will be given at following rate :

Initial loading of 150 mg/kg/hr over 1 hour Followed by 12.5mg/kg/hr for 4 hrs Then continuous infusion of 6.25 mg/kg for the remaining 67 hrs

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • Not Applicable

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
    • Delhi
      • New Delhi, Delhi, India, 110070
        • Institute of Liver & Biliary Sciences

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 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age > 18 and < 75
  • Cirrhotics with UGIE (Upper Gastrointestinal Endoscopy ) within last 24 hours.

Exclusion Criteria:

  • Non cirrhotic
  • Hepatocellular carcinoma
  • Advanced cardiopulmonary disease
  • Pregnancy
  • Extrahepatic malignancy
  • Patient on anticoagulation therapy

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
EXPERIMENTAL: Standard Care + NAC (N-ACETYLCYSTEINE) infusion
Drug: Standard Care + NAC (N -ACETYLCYSTEINE)
Drug: Standard Care (in control arm)
ACTIVE_COMPARATOR: Standard Care
Drug: Standard Care (in control arm)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To study the efficacy of NAC (N -ACETYLCYSTEINE) in preventing ischemic hepatitis in cirrhotics with upper Gastrointestinal bleed.
Time Frame: Day 5
Day 5

Secondary Outcome Measures

Outcome Measure
Time Frame
To study effect of NAC (N -ACETYLCYSTEINE) infusion on 5 day survival post bleed.
Time Frame: 6 weeks
6 weeks
To study incidence of complication like AKI (Acute Kidney Injury), HE(Hepatic Encepahlopathy) and SBP(Spontaneous Bacterial Peritonitis).
Time Frame: day 5
day 5

Collaborators and Investigators

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

Sponsor

Institute of Liver and Biliary Sciences, India

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

December 1, 2013

Primary Completion (ACTUAL)

May 1, 2015

Study Completion (ACTUAL)

May 1, 2015

Study Registration Dates

First Submitted

December 13, 2013

First Submitted That Met QC Criteria

December 18, 2013

First Posted (ESTIMATE)

December 19, 2013

Study Record Updates

Last Update Posted (ACTUAL)

September 13, 2019

Last Update Submitted That Met QC Criteria

September 11, 2019

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ILBS-IH-01

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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