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

Not Applicable

Completed

• Conditions: Ischemic Hepatitis
• Interventions: Drug: Standard Care + NAC (N -ACETYLCYSTEINE); Drug: Standard Care (in control arm)

• Registration Number: NCT02015403
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-13
• Study First Submitted QC: 2013-12-18
• Study First Posted: 2013-12-19
• Status Verified: 2015-03
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Last Update Submitted: 2019-09-11
• Last Update Posted: 2019-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Care + NAC (N-ACETYLCYSTEINE) infusion	Standard Care + NAC (N -ACETYLCYSTEINE)	-
Standard Care + NAC (N-ACETYLCYSTEINE) infusion	Standard Care (in control arm)	-
Standard Care	Standard Care (in control arm)	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Institute of Liver & Biliary Sciences; 🇮🇳 New Delhi, Delhi, India