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Record W4416217551 · doi:10.1016/s0140-6736(25)01717-9

A preventive care strategy to reduce moderate or severe acute kidney injury after major surgery (BigpAK-2); a multinational, randomised clinical trial

2025· article· en· W4416217551 on OpenAlexfundno aff
Alexander Zarbock, Marlies Ostermann, Lui G. Forni, Christian Bode, Lennart Wild, Christian Putensen, Diego Parise Roux, E Martin, Christian Arndt, Tim Rahmel, Silvia De Rosa, Céline Monard, Antoine Schneider, Adam Glass, Mona Jung-König, Stefano Romagnoli, James Gossage, Nuttha Lumlertgul, Jan Gerrit Haaker, Javier Ripollés‐Melchor, Savino Spadaro, Antonio Daniele Pinna, Emmanuel Futier, Lucie Aupetitgendre, Irene Romero Bhathal, Raquel García-Álvarez, Alice Bernard, Peter Rosenberger, Carola Wempe, Mahan Sadjadi, Melanie Meersch, Karen Fischhuber, John A. Kellum, Thilo von Groote

Bibliographic record

VenueThe Lancet · 2025
Typearticle
Languageen
FieldMedicine
TopicAcute Kidney Injury Research
Canadian institutionsnot available
FundersCanadian Institutes of Health ResearchNational Institutes of HealthbioMérieuxHealth Research Council of New ZealandWestfälische Wilhelms-Universität Münster
KeywordsAcute kidney injuryClinical trialPreventive careMEDLINERandomized controlled trial

Abstract

fetched live from OpenAlex

BACKGROUND: Acute kidney injury (AKI) is a common and important complication of major surgery, yet recommended preventive care is rarely administered. We used urinary biomarkers to identify patients at high risk of AKI and implemented a preventive care strategy to reduce AKI within 72 h after major surgery. METHODS: BigpAK-2 was a multicentre randomised clinical trial done in 34 hospitals in Europe. Patients (aged ≥18 years) undergoing major surgery at high risk for AKI identified by predefined clinical risk factors and tubular stress biomarkers were randomly assigned to usual care or a preventive care strategy as per recommendations by the Kidney Disease Improving Global Outcome guidelines: advanced hemodynamic monitoring, optimisation of volume status and haemodynamics, avoidance of nephrotoxic drugs and radiocontrast agents, and prevention of hyperglycaemia. The primary outcome was the occurrence of moderate or severe AKI within 72 h after surgery, assessed in the intention-to-treat population. Safety was assessed by comparing rates of adverse events between groups. This trial is registered with ClinicalTrials.gov, NCT04647396. FINDINGS: From Nov 25, 2020, to June 21, 2024, 7873 patients were screened and 1180 (15·0%) were randomly assigned (589 [49·9%] to the intervention group and 591 [50·1%] to the control group). Among the 1176 patients available for the primary endpoint analysis, moderate or severe AKI occurred in 84 (14·4%) patients in the intervention group and in 131 (22·3%) patients in the control group (odds ratio 0·57 [95% CI 0·40-0·79; p=0·0002; number needed to treat 12 [7-33]). There were no differences in adverse events. The most common adverse events were atrial fibrillation (50 [8·8%] in the intervention group vs 56 (9·7%) in the control group), hemodynamically relevant arrhythmias (41 [7·2%] in the intervention group vs 50 [8·6%] in the control group), significant bleeding or haemorrhage (34 [6·0%] in the intervention group vs 31 [5·3%] in the control group), and unplanned return to the operating room (29 [5·1%] in the intervention vs 38 [6·5%] in the control group). INTERPRETATION: Among adults at high risk for AKI undergoing major surgery, a preventive care strategy consisting of supportive measures and avoidance of nephrotoxins significantly reduced the occurrence of moderate or severe AKI without increasing adverse events. FUNDING: BioMérieux.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame distilled prediction

Teacher imitation

Not 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.

metaresearch head score (Codex)0.002
metaresearch head score (Gemma)0.005
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Randomized trial · Consensus signal: Randomized trial
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.316
Threshold uncertainty score0.924

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0020.005
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0010.000
Bibliometrics0.0000.001
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.001
Insufficient payload (model declined to judge)0.0010.000

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.

Opus teacher head0.088
GPT teacher head0.442
Teacher spread0.355 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one teacher head, not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designRandomized trial
Domainnot available
GenreEmpirical

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".

Quick stats

Citations27
Published2025
Admission routes1
Has abstractyes

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