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

Ischemic Hepatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02015403
• Other study ID #: ILBS-IH-01
• Status: Completed
• Phase: N/A
• Start date: December 2013
• Est. completion date: May 2015

Study information

• Verified date: March 2015
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Ischemia
• Ischemic Hepatitis

Intervention

Drug:
• Standard Care + NAC (N -ACETYLCYSTEINE)

• Standard Care (in control arm)

Locations

Country	Name	City	State
India	Institute of Liver & Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To study the efficacy of NAC (N -ACETYLCYSTEINE) in preventing ischemic hepatitis in cirrhotics with upper Gastrointestinal bleed.		Day 5
Secondary	To study effect of NAC (N -ACETYLCYSTEINE) infusion on 5 day survival post bleed.		6 weeks
Secondary	To study incidence of complication like AKI (Acute Kidney Injury), HE(Hepatic Encepahlopathy) and SBP(Spontaneous Bacterial Peritonitis).		day 5