Protocol of the exploratory prospective observational PEAK study: PrEcision medicine in the management of cardiovascular surgery associated Acute Kidney Injury (AKI)
Bibliographic record
Abstract
INTRODUCTION: Acute kidney injury (AKI) due to temporary renal ischaemia is a common, life-threatening complication of many invasive surgical procedures, particularly among the critically ill, frail and elderly. Since no targeted interventions are currently available, innovative strategies for prediction, early detection and personalised treatment of AKI are urgently needed. Based on our results from preclinical renal ischaemia-reperfusion injury models, we postulate that the excess release of cytotoxic calcium phosphate-loaded particles from dying cells and their reuptake by neighbouring cells drive a self-perpetuating necroinflammatory process causing AKI. Furthermore, replenishing the hepatokine fetuin-A, which is rapidly consumed in this process by binding and rendering inert the cellular calcium phosphate debris, can disrupt this vicious cycle. We hypothesise that low plasma levels of fetuin-A are an important patient-specific biomarker associated with AKI and worse clinical outcome after cardiovascular surgery (CVS). METHODS AND ANALYSIS: This is a monocentric, prospective, observational study in which the behaviour of fetuin-A in association with frailty and AKI is assessed in 100 patients undergoing elective CVS. The primary objective is to describe the difference between serum fetuin-A at baseline and the day after surgery. Secondary objectives include the description of the course of fetuin-A and a panel of biomarkers with high temporal granularity measured before and during surgery (five time points), and at days 1, 2 and 3 after operation. A potential association of fetuin-A with the occurrence of AKI (at day 7 or discharge) or with chronic kidney disease (at day 90) is investigated. In addition, the Edmonton Frailty Scale (recorded as patient reported outcome measure at baseline and day 90) is used to determine how the degree of frailty affects surgical outcomes. An interim analysis will be conducted after 30 patients have been included. ETHICS AND DISSEMINATION: This study was approved by the cantonal ethics committee (Kantonale Ethikkommission) Bern (ID: 2023-02024) and is conducted in accordance with the ethical principles of the Declaration of Helsinki. Results of the study, which will be published in a peer-review journal, will determine whether our aforementioned hypothesis is correct. If so, an established correlation between fetuin-A levels and CVS-associated AKI would facilitate the transitioning of our preclinical work to patient-centred research. TRIAL REGISTRATION NUMBER: NCT06471621.
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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 | 0.023 | 0.024 |
| Meta-epidemiology (narrow) | 0.003 | 0.002 |
| Meta-epidemiology (broad) | 0.004 | 0.002 |
| Bibliometrics | 0.002 | 0.003 |
| Science and technology studies | 0.002 | 0.002 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.003 | 0.002 |
| Research integrity | 0.003 | 0.002 |
| Insufficient payload (model declined to judge) | 0.022 | 0.006 |
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".