Effects of RBT‐1 on the Occurrence of Postoperative Complications in Patients Undergoing Cardiac Surgery
Bibliographic record
Abstract
Objectives Approximately two‐thirds of patients undergoing cardiac surgery experience postoperative complications, which may lead to significant clinical consequences. RBT‐1, an investigational drug with anti‐inflammatory and antioxidant properties, elicits a preconditioning response and was shown to improve clinical outcomes when administered within 24–48 hours prior to surgery (modified intention‐to‐treat population). The current post hoc analysis evaluated the efficacy of RBT‐1 in reducing postoperative complications in the entire study population without excluding patients based on when surgery occurred relative to study drug administration. Methods A total of 135 patients were randomized to receive a single infusion of RBT‐1 ( n = 91) or placebo ( n = 44) at least 1 day before undergoing nonemergent coronary artery bypass graft (CABG) and/or heart valve surgery on cardiopulmonary bypass (CPB) and were followed for 90 days postsurgery. Clinical outcomes assessed included ventilator time, intensive care unit (ICU) and hospital length of stay (LOS), cardiopulmonary readmission, and other clinical events of interest. Results In this analysis, RBT‐1 reduced ventilator time, ICU, and hospital LOS by 0.98 days (NS), 2.59 days ( p = 0.026), and 1.35 days (NS), respectively, compared with placebo. The incidence of 30‐day cardiopulmonary readmission was significantly reduced by RBT‐1 (4.6% vs. 17.5%, placebo; p = 0.035). Additionally, RBT‐1 showed a trend in reductions in several clinical events of interest, including anemia, atrial fibrillation, and fluid overload. Conclusions Trends in improved clinical outcomes were seen with RBT‐1 treatment in this post hoc analysis that included all patients enrolled in a Phase 2 clinical study regardless of surgery delay beyond 2 days posttreatment. A Phase 3 study is underway to confirm these improved clinical outcomes in a larger study population. Trial Registration: ClinicalTrials.gov identifier: NCT06021457
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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 | 0.001 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| 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".