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
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
1 other identifier
interventional
220
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 13, 2013
CompletedFirst Posted
Study publicly available on registry
December 19, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedSeptember 13, 2019
March 1, 2015
1.4 years
December 13, 2013
September 11, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
To study the efficacy of NAC (N -ACETYLCYSTEINE) in preventing ischemic hepatitis in cirrhotics with upper Gastrointestinal bleed.
Day 5
Secondary Outcomes (2)
To study effect of NAC (N -ACETYLCYSTEINE) infusion on 5 day survival post bleed.
6 weeks
To study incidence of complication like AKI (Acute Kidney Injury), HE(Hepatic Encepahlopathy) and SBP(Spontaneous Bacterial Peritonitis).
day 5
Study Arms (2)
Standard Care + NAC (N-ACETYLCYSTEINE) infusion
EXPERIMENTALStandard Care
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Age \> 18 and \< 75
- Cirrhotics with UGIE (Upper Gastrointestinal Endoscopy ) within last 24 hours.
You may not qualify if:
- Non cirrhotic
- Hepatocellular carcinoma
- Advanced cardiopulmonary disease
- Pregnancy
- Extrahepatic malignancy
- Patient on anticoagulation therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070, India
Related Publications (1)
Maiwall R, Kumar A, Bhadoria AS, Jindal A, Kumar G, Bhardwaj A, Maras JS, Sharma MK, Sharma BC, Sarin SK. Utility of N-acetylcysteine in ischemic hepatitis in cirrhotics with acute variceal bleed: a randomized controlled trial. Hepatol Int. 2020 Jul;14(4):577-586. doi: 10.1007/s12072-020-10013-5. Epub 2020 Feb 11.
PMID: 32048131DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2013
First Posted
December 19, 2013
Study Start
December 1, 2013
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
September 13, 2019
Record last verified: 2015-03