COMMENCE Trial – Comparing hypOtherMic teMperaturEs duriNg hemiarCh surgEry A Randomized Controlled Trial of Mild vs Moderate Hypothermia on Patient Outcomes in Aortic Hemiarch Surgery with Anterograde Cerebral Perfusion
Bibliographic record
Abstract
Abstract Background Aortic arch surgery remains the only viable life-saving treatment for aortic arch disease. However, the necessity for cessation of systemic blood flow with hypothermic cardiac arrest carries substantial risk of morbidity and mortality, including poor neurological outcomes and kidney failure. While uncontrolled studies have suggested the safety of operating at warmer temperatures, significant variables remain un-investigated supporting the need for a randomized clinical trial to produce evidence-based guidelines for perfusion strategies in aortic surgery. This study proposes a multi-centre RCT, in order to compare outcomes of warmer hypothermic strategies during hemiarch surgery on a composite endpoint of neurologic and acute kidney injury. Methods This is a prospective multi-centre, single-blind two-arm RCT comparing mild (32°C) versus moderate (26°C) hypothermic cardiac arrest in patients (n=282) undergoing aortic hemiarch surgery with antegrade cerebral perfusion. The primary endpoint is a composite of neurological injury (incidence of TIA and/or stroke) and acute kidney injury (1 or higher). Secondary outcomes include death, cardiopulmonary bypass time, bleeding, transfusion rates, prolonged mechanical ventilation, myocardial infarction, length of stay, and quality of life measures. Patients will undergo 1:1 block randomization to each treatment arm on day of surgery. Sequence of operation will be at the surgeon's discretion with mandatory guidelines for temperature and antegrade cerebral perfusion administration. Perioperative management will occur as per enrolling centre standard of care. Neurocognitive function will be assessed using validated neurological screening tests: NIHSS, MOCA, BI, and MRS. Diagnosis and classification of acute kidney injury will be assessed using creatinine measurements. Study duration for each patient will be 60±30 days. Discussion It is hoped that performing hemiarch surgery using mild hypothermia (32°C) and selective anterograde cerebral perfusion will result in a 15% absolute risk reduction in the composite outcomes. The potential of this risk reduction will translate into improved patient outcomes, survival, and long-term financial savings to the Health Care system. In addition to this, the results of this trial will be used to create the first-ever guidelines for temperature management strategy during aortic surgery.
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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 | 0.006 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.004 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.007 | 0.001 |
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".