Ischemic Hepatitis
Conditions
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
Interventions
DRUGStandard Care + NAC (N -ACETYLCYSTEINE)
DRUGStandard Care (in control arm)
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To study the efficacy of NAC (N -ACETYLCYSTEINE) in preventing ischemic hepatitis in cirrhotics with upper Gastrointestinal bleed. | Day 5 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
India
Outcome results
None listed