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

Institute of Liver and Biliary Sciences, India

Status: Completed

Conditions: Ischemic Hepatitis

Treatments: Drug: Standard Care + NAC (N -ACETYLCYSTEINE); Drug: Standard Care (in control arm)

Study type: Interventional

Funder types: Other

Identifiers

NCT02015403

ILBS-IH-01

Details and patient eligibility

About

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

Enrollment: 220 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

220 participants in 2 patient groups

Standard Care + NAC (N-ACETYLCYSTEINE) infusion

Experimental group

Treatment:

Drug: Standard Care (in control arm)

Drug: Standard Care + NAC (N -ACETYLCYSTEINE)

Standard Care

Active Comparator group

Treatment:

Drug: Standard Care (in control arm)