Custodiol versus Plegisol: A phase 3 multicentre myocardial protection study
Why this work is in the frame
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Bibliographic record
Abstract
BACKGROUND: While considered simple and effective, crystalloid antegrade cardioplegia solutions have had few prospective multicentre comparison trials. METHODS: A commercial intracellular-type histidine-tryptophan-ketoglutarate (HTK) cardioplegia solution (Custodiol HTK; Köhler Chemie GmbH, Germany) designed for 4 h of protection after a single administration was compared with a standard extracellular multidose product (Plegisol [PL]; Hospira Inc, USA) in an open-label, randomized, prospective seven-institution trial. A total of 136 isolated coronary bypass patients were randomly assigned into two groups and stratified by ejection fraction into categories of 40% or greater (n=118) and 20% to 39% (n=18). RESULTS: The mean age of the study cohort was 62 years, of which 94% were men. Seventy per cent of patients had Canadian Cardiovascular Society class III angina and 75% had three-vessel disease anatomy. Cross-clamp times were nearly identical for patients in both cardioplegia groups; however, defibrillation was needed less often for patients who were treated with HTK (64% versus 91%, P<0.01). Hospital and intensive care unit stays, creatine kinase isoenzyme MB curves, cardiac outputs, inotrope levels, and deaths or serious adverse events (PL=13, HTK=14) were very similar between groups. Logistic regression showed that myocardial infarction or possible treatment-related adverse events were associated with high cardiac troponin I (cTn-I) levels 6 h after the procedure (P=0.001), and HTK treatment (OR 3.5, P=0.01). The primary study end point (6 h post-ischemia cTn-I) favoured PL (16.7±13.2 μg/L versus 20.3±13.5 μg/L, P=0.01). Patients who underwent circumflex grafting had higher cTn-I levels with HTK (P<0.001) and 48% required reinfusions due to cardiac warming. Longer intervals between doses correlated with high cTn-I levels (P=0.02). HTK provided prolonged protection with low cTn-I release (10 μg/L or less), although this occurred less frequently than with PL (17 versus 27 patients, P=0.06). CONCLUSIONS: HTK caused more structural protein release and adverse events than PL, even when reinfusion was implemented.
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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 | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| 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 it