Effect of Polymyxin B Hemoadsorption on Mortality in Patients with Endotoxic Septic Shock: The TIGRIS Trial
Bibliographic record
Abstract
Background: Despite multiple trials and years of clinical use, evidence for effectiveness of polymyxin B hemoadsorption (PMX) on mortality in endotoxic septic shock (ESS) is inconclusive. Methods: We sought to determine the probability that PMX reduces mortality at 28 and 90 days compared to standard of care for patients with ESS defined by endotoxin activity ≥0.6 but <0.9 units plus multiple organ failure. Tigris was a 19-center randomized trial in the US using a Bayesian analysis with an informative prior. Subjects were randomized 2:1 to receive PMX administered twice, for 2 hours each, using an extracorporeal veno-venous circuit at 100 ml/min, or standard of care. Mortality was assessed at 28 days (primary endpoint) and 90 days (key secondary endpoint). The treatment effect was estimated by the odds ratio (OR) comparing PMX to control, adjusting for the baseline APACHE II in a logistic regression model. The primary analysis used an informative normal prior distribution on the APACHE II-adjusted log-OR for PMX based on a discounted (down to 75%) estimate from logistic regression in a sample of 179 patients from the EUPHRATES trial with ESS. Results: The final analysis included 157 patients from Tigris. Mortality at 28 days was 41/106 (38.7%) with PMX compared to 23/51 (45.1%) with standard of care alone. We found a 95.3% posterior probability that PMX is beneficial at 28 days compared to standard of care alone (OR with 95% credible interval: 0.67 (0.39, 1.08)). At 90 days mortality was 46/106 (43.4%) with PMX compared to 31/51 (60.8%) with standard of care alone and a posterior probability of benefit of 99.4% (OR: 0.54 (0.32, 0.87)). The unadjusted absolute risk reduction (ARR) from the posterior distribution was 8.3% [-2.1%, 19.7%] at 28 days, posterior probability of ARR >0, 92.3%. At 90 days the ARR was 12.3% [0.76%, 23.7%], posterior probability of ARR >0, 98.3%. The resultant number needed to treat to save one life was 12 at 28 days and 8 at 90 days. Conclusion: A mortality benefit from PMX treatment was observed for patients with ESS. Funding: Commercial Support - Spectral Medical
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.004 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.002 | 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 source (direct Gemma or distilled Codex), 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".