Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care + NAC (N-ACETYLCYSTEINE) infusion | Experimental |
| |
| Standard Care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Care + NAC (N -ACETYLCYSTEINE) | Drug |
| ||
| Standard Care (in control arm) |
| Measure | Description | Time Frame |
|---|---|---|
| To study the efficacy of NAC (N -ACETYLCYSTEINE) in preventing ischemic hepatitis in cirrhotics with upper Gastrointestinal bleed. | Day 5 |
| Measure | Description | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Liver & Biliary Sciences | New Delhi | National Capital Territory of Delhi | 110070 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32048131 | Derived | Maiwall R, Kumar A, Bhadoria AS, Jindal A, Kumar G, Bhardwaj A, Maras JS, Sharma MK, Sharma BC, Sarin SK. Utility of N-acetylcysteine in ischemic hepatitis in cirrhotics with acute variceal bleed: a randomized controlled trial. Hepatol Int. 2020 Jul;14(4):577-586. doi: 10.1007/s12072-020-10013-5. Epub 2020 Feb 11. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided