Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2026-01-02 @ 7:42 AM
Study NCT ID:
NCT02015403
Status:
COMPLETED
Last Update Posted:
2019-09-13
First Post:
2013-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Institute of Liver and Biliary Sciences, India
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: