NCT02015403

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Institute of Liver and Biliary Sciences, India · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Standard Care + NAC (N -ACETYLCYSTEINE)
DRUG	Standard Care (in control arm)

Timeline

• Start date: 2013-12-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2013-12-19
• Last updated: 2019-09-13

Locations

1 site across 1 country: India