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Steroids were given for 2 patients who had biopsy proven Drug induced Liver Injury and both have them developed sepsis.
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Intervention - Subjects will be randomized to 2 groups
Group A - subjects will receive Prednisolone for 20 days with NAC (N-Acetylcysteine)
Group B - will receive NAC (N-Acetylcysteine) only NAC (N-acetylcysteine) dosing
Loading dose: 150 mg/kg IV; mix in 200 mL of 5% dextrose in water (D5W) and infuse over 1 hour
Dose 2: 50 mg/kg IV in 500 mL D5W over 4 h
Dose 3: 100 mg/kg IV in 1000 mL D5W over 16 h
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prednisolone + N-Acetylcysteine | Experimental | Prednisolone for 20 days with NAC (N-Acetylcysteine) NAC (N-Acetylcysteine) dosing-Loading dose: 150 mg/kg IV; mix in 200 mL of 5% dextrose in water (D5W) and infuse over 1 h Dose 2: 50 mg/kg IV in 500 mL D5W over 4 h Dose 3: 100 mg/kg IV in 1000 mL D5W over 16 h |
|
| N-Acetylcysteine | Active Comparator | NAC (N-Acetylcysteine) dosing-Loading dose: 150 mg/kg IV; mix in 200 mL of 5% dextrose in water (D5W) and infuse over 1 h Dose 2: 50 mg/kg IV in 500 mL D5W over 4 h Dose 3: 100 mg/kg IV in 1000 mL D5W over 16 h |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisolone | Drug |
| ||
| N-Acetylcysteine |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with normalization of LFT (Liver Function Test) in both groups. | Normalization of LFT (Liver Function Test) which is defined as Total bilirubin within normal limits. | 20 days |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in of Histology. | Improvement is defined as decrease in inflammation, decrease in cholestasis. | 20 days |
| Improvement in CBC profile | Improvement is defined normalization of CBC profile. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Anand Kulkarni V, MD | Institute of Liver and Biliary Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of liver and Biliary Sciences | New Delhi | National Capital Territory of Delhi | 110070 | India |
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| ID | Term |
|---|---|
| D056486 | Chemical and Drug Induced Liver Injury |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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NAC (N-Acetylcysteine) dosing-Loading dose: 150 mg/kg IV; mix in 200 mL of 5% dextrose in water (D5W) and infuse over 1 h Dose 2: 50 mg/kg IV in 500 mL D5W over 4 h Dose 3: 100 mg/kg IV in 1000 mL D5W over 16 h |
|
| 20 days |
| Improvement in coagulation profile | Improvement is defined normalization of Coagulation profile. | 20 days |
| Improvement in KFT profile | Improvement is defined normalization of KFT profile. | 20 days |
| Proportion of patients develop adverse effects in both groups. | 20 days |
| D011041 | Poisoning |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |