Trial · NCT04072822
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Survival at 90 Days | 90 days | The primary analysis will be comparisons of 90-day mortality of Prednisone and Anakinra plus zinc vs Prednisone. |
| Secondary | To Measure the Changes in Lille Score | Day 7 | Change in Lille score is represented as the percentage of participants who achieved a Lille score \< 0.45 on day 7. The Lille score will be calculated using the following website: https://www.mdcalc.com/lille-model-alcoholic-hepatitis Lille score = (exp(-R))/(1 + exp(-R)) where the variables are as follows: R = 3.19 - 0.101\*(age, years) + 0.147\*(albumin day 0, g/L) + 0.0165\* (evolution in bilirubin level, µmol/L) - 0.206\*(renal insufficiency) - 0.0065\*(bilirubin day 0, µmol/L) - 0.0096\*(prothrombin time, sec) Renal insufficiency = 1 (if creatinine \>1.3 mg/dL (115 µmol/L)) or 0 (if ≤1.3 mg/dL (115 µmol/L)) The Lille score was developed to provide early recognition of patients with severe alcoholic hepatitis not responding to corticosteroids. Lower scores indicate more improvement in response to corticosteroids. A Lille score \> 0.45 predicts worse 6-month survival. A Lille score \< 0.45 predicts better 6-month survival. |
| Secondary | Changes in MELD Score | 7, 30, and 90 days | The Model for End-Stage Liver Disease (MELD) is a numerical scale, ranging from 6 (less ill) to 40 (gravely ill), used for liver transplant candidates age 12 and older. It gives each person a 'score' (number) based on how urgently he or she needs a liver transplant within the next three months. |
| Secondary | Number of Participants With AKI (Acute Kidney Injury) | 7, 30, and 90 days | * Increase in creatinine of 50% above baseline over a period of 7 days * Increase in creatinine of 0.3 mg/dl within a period of 48 hrs * Onset of renal failure requiring dialysis |
| Secondary | Development of Multi-organ Failure | 7, 30, and 90 days | Defined as failure ≥2 organs |
| Secondary | Development of SIRS (Systemic Inflammatory Response Syndrome) | 7, 30, and 90 days | Defined as two or more abnormalities in temperature, increased heart rate, respiration, or white blood cell count with increase in SOFA score ≥2 points |
| Secondary | Number of Transfers to ICU | 7, 30, and 90 days | Recording the change of hospital word from regular floor to ICU floor as a marker for worsening illness and care escalation |
| Secondary | Changes in Liver Function | 7, 30, and 90 days | Changes in liver function were evaluated by changes in the Child Pugh Score at days 7, 30, and 90. The Child Pugh Score is a scoring system used to assess the severity of chronic liver disease. Scores range from 5 to 15, with higher scores indicating more severe disease. Points are assigned as follows: Hepatic encephalopathy: None = 1 point, Grade 1 and 2 = 2 points, Grade 3 and 4 = 3 points Ascites: None = 1 point, mild = 2 points, moderate to severe = 3 points Total Bilirubin: under 2 mg/dl = 1 point, 2 to 3 mg/dl = 2 points, over 3 mg/dl = 3 points Albumin: greater than 3.5g/dl = 1 point, 2.8 to 3.5g/dl = 2 points, less than 2.8g/dl = 3 points International normalised ratio (INR): under 1.7 = 1 point, 1.7 to 2.3 = 2 points, above 2.3 = 3 points Assigned points for each category are summed to calculate the Child Pugh Score. |
| Secondary | Number of Participants With Changes in Sequential Organ Failure Assessment (SOFA) Scores and Proportions Requiring Hemodynamic Support for MAP < 65 mm Hg and Lactate > 2 mmol/l, Renal Replacement Therapy or Mechanical Ventilation. | 180 days | The SOFA score will be calculated at the following website https://www.mdcalc.com/sequential-organ-failure-assessment-sofa-score Scores can be from 0 - \>14 (favorable to less favorable) |
| Secondary | Number of Participants With Infections | 180 days | |
| Secondary | Number of Participants With Progression of Sepsis | 180 days | * Life-threatening organ dysfunction caused by a dysregulated host response to infection * An increase in SOFA score of 2 points of more * Note: most participants with severe AH have 4 points based on bilirubin only |
| Secondary | Percentage of Participants With Renal Dysfunction | 180 days | Defined by a creatinine \> 2 mg/dl |
| Secondary | Number of Participants Requiring Transfer to ICU for Care, Intubation for Airway Control, Need for Ventilator Support or RRT. | 180 days | |
| Secondary | Indicators of Gut Permeability | 180 days | |
| Secondary | Survival | 30 days and 180 days | |
| Secondary | Transplant Free Survival Rate | 90 Days |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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