ArticleBMJ open2025
Hydrocortisone for the prevention of postoperative delirium in digestive surgery (HyPOD): study protocol for a multicentre randomised, blinded, placebo-controlled trial.
Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Corrections and comments
- Erratum issued
Authors and funding
8 authors.
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No grant is acknowledged in the PubMed record.
Abstract
introductionPostoperative delirium (POD) is a significant complication in digestive surgery, potentially increasing hospital stays, costs and mortality. Corticoids, such as dexamethasone and methylprednisolone, have been reported to reduce POD. However, the efficacy of hydrocortisone (HC) remains unexplored. This trial aims to evaluate HC's effectiveness in preventing POD in surgical patients. METHODS AND ANALYSIS: A multicentre (three hospitals), randomised, blinded (patient-blinded, surgeon-blinded, anaesthesiologist-blinded and monitor-blinded), placebo-controlled trial of HC for the prevention of POD in patients undergoing digestive surgery was started in June 2024. Patients undergoing digestive surgery are randomly assigned to the HC or placebo group. The stratification factors are age, sex, disease stage and procedure type. Before skin incision, the participants in the HC group are administered 500 mg HC intravenously. The participants in the placebo group are administered the same volume of saline that is indistinguishable from the HC. The primary outcome is the presence of POD from postoperative days 1 to 3, which is assessed using the Confusion Assessment Method-ICU (CAM-ICU). The secondary outcomes are changes in serum sodium levels, postoperative mortality, length of hospital stay, functional independence measures and complications within 28 days. To date, 61 patients of a planned 180 have been enrolled in the study. ETHICS AND DISSEMINATION: This protocol was approved by the Nagoya University Clinical Research Review Board and was registered with the Japan Registry of Clinical Trials on 24 May 2024. The results of this trial will be disseminated through peer-reviewed journals. TRIAL REGISTRATION NUMBER: jRCTs041240032.
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