Infections in Standard or Tapered Dose of Prednisolone for Alcohol-Associated Hepatitis: A Randomized Trial (STASH Trial)
Bibliographic record
Abstract
INTRODUCTION: Current guidance recommends a 40-mg dose of prednisolone (or equivalent) for severe alcohol-associated hepatitis (AAH), while infections are not uncommon in them. The benefits of a rapid prednisolone tapering regimen in mitigating infection in patients with AAH are unknown. The primary objective was to assess the incidence of infection by day 90. The key secondary objectives were the incidence of mortality, acute kidney injury, readmissions rate, and adverse events. METHODS: In this multicenter randomized clinical trial, patients with severe AAH were included from March 15, 2023, to August 28, 2024. Patients were randomly assigned to receive a standard fixed prednisolone dose (40 mg/d) for 4 weeks or 40 mg/d tapered by 10 mg/d every week over 4 weeks. RESULTS: Two hundred fifty-four patients were enrolled (age: 41.16 ± 8.2 years, 98% men). The incidence of infection on day 90 was 33.1% (42 of 127; 95% confidence interval [CI] 23.8-44.7) in the fixed-dose group compared with 19.7% (25 of 127; 95% CI 16.1-37) in the tapered dose group, with a hazard ratio of 0.57 (95% CI 0.35-0.94; P = 0.03). On competing risk regression analysis after adjustment for relevant covariates, tapered dose of prednisolone was associated with a lower incidence of infection by day 90 (subdistribution hazard ratio 0.34; 95% CI 0.15-0.78; P = 0.01). Nineteen percent (24/127; 95% CI 12.5-26.8) in the fixed-dose group and 8.6% (11/127; 95% CI 4.4-14.9; P = 0.02) in the tapered-dose group had microbiologically proven infections. There were no differences in mortality, acute kidney injury incidence, hospitalizations, or all-cause adverse events. DISCUSSION: In patients with severe AAH, a tapered prednisolone regimen may mitigate the frequency of infections (CTRI/2023/03/050521).
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.003 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".