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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

NCT02015403 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2019-09-13

No results posted yet for this study

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

Conditions

  • Ischemic Hepatitis

Interventions

DRUG

Standard Care + NAC (N -ACETYLCYSTEINE)

DRUG

Standard Care (in control arm)

Sponsors & Collaborators

  • Institute of Liver and Biliary Sciences, India

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • India

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02015403 on ClinicalTrials.gov