Positività 0,97% e 2,8%, ma va confermata. Verso test nazionale
Risultati per: Il delirium nel paziente anziano assistito al domicilio: uno studio pilota nella Medicina Generale
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Positività 0,97% e 2,8%, ma va confermata. Verso test nazionale
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Efficacy of subanaesthetic esketamine on the prevention of postoperative delirium in older adult patients after cardiovascular surgery: protocol for a single-centre, randomised, double-blind, placebo-controlled trial (SEPDOC trial) in China
Introduction
Postoperative delirium (POD) is a common and serious complication in older adult patients undergoing cardiovascular surgery. Esketamine is known for its anti-inflammatory and neuroprotective properties. While it has shown preventive effects on POD in those not undergoing cardiovascular surgery, its efficacy in older adult patients undergoing cardiovascular surgery remains uncertain. Therefore, we herein aimed to evaluate the preventive effect of intraoperative subanaesthetic esketamine on POD in this specific population.
Methods and analysis
This single-centre, randomised, double-blind, placebo-controlled trial will enrol 778 patients aged 60–80 years undergoing open-heart cardiovascular surgery in China, from September 2023 to December 2025. The participants will be randomly assigned in a 1:1 ratio to the following groups: the esketamine group and the control group. In the esketamine group, esketamine (2 mg/mL) will be administered intravenously at a dosage of 0.3 mg/kg over 10 min following tracheal intubation, followed by a continuous infusion at 0.15 mg/kg/h until the end of the surgery. Patients in the control group will receive a placebo following the same dosage and regimen. The incidence of POD will be the primary outcome and will be assessed twice daily from the first to the seventh postoperative day. The postoperative sleep quality, duration of postoperative mechanical ventilation, and length of hospital and intensive care unit stay will be the secondary outcomes.
Ethics and dissemination
Ethical approval was obtained from the Institutional Review Board of Fuwai Central China Cardiovascular Hospital (No. 2023068). Public disclosure is guaranteed post-trial, and the results will be published in a peer-reviewed scientific journal.
Trial registration number
ChiCTR2300074395.
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Protocol for a prospective cohort study to determine the multimodal biomarkers of delirium and new dementia after acute illness in older adults: ORCHARD-PS
Introduction
Delirium is common in the older hospital population and is often precipitated by acute illness. Delirium is associated with poor outcomes including subsequent cognitive decline and dementia and may therefore be a modifiable risk factor for dementia. However, the mechanisms underpinning the delirium–dementia relationship and the role of coexisting acute illness factors remain uncertain. Current biomarker studies of delirium have limitations including lack of detailed delirium characterisation with few studies on neurodegenerative or neuroimaging biomarkers especially in the acute setting. The Oxford and Reading Cognitive Health After Recovery from acute illness and Delirium—Prospective Study (ORCHARD-PS) aims to elucidate the pathophysiology of delirium and subsequent cognitive decline after acute illness in older adults, through acquisition of multimodal biomarkers for deep phenotyping of delirium and acute illness, and follow-up for incident dementia.
Methods and analysis
ORCHARD-PS is a bi-centre, prospective cohort study. Consecutive eligible patients requiring acute hospital admission or assessment are identified by the relevant acute clinical care team. All patients age >65 years without advanced dementia, nursing home residence, end-stage frailty or terminal illness are eligible. Details of potential participants are communicated to the research team and written informed consent or consultee agreement is obtained. Participants are interviewed as soon as possible after admission/assessment using a structured proforma.
Data are collected on demographics, diagnosis and comorbidities, social and functional background. Delirium is assessed using the 4A’s test, Confusion Assessment Method (long-form), Observational Scale of Level of Arousal, Richmond Agitation-Sedation Scale and Memorial Delirium Assessment Scale and diagnosed using the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria. Delirium is categorised by time of onset (prevalent vs incident), dementia status, motoric subtype, severity and duration. Cognitive tests include the 10-point Abbreviated Mental Test and Montreal Cognitive Assessment. Participants are reassessed every 48–72 hours if remaining in hospital. Informant questionnaire data and interview are supplemented by hand searching of medical records and linkage to electronic patient records for nursing risk assessments, vital observations, laboratory results and International Classification of Diseases, Tenth Revision diagnostic and procedure codes.
In-person follow-up with more detailed cognitive testing and informant interview is undertaken at 3 months, and 1 and 3 years supplemented with indirect follow-up using medical records. Blood banking is performed at baseline and all follow-ups for future biomarker analyses. CT-brain and MRI-brain imaging acquired as part of standard care is obtained for quantification of brain atrophy and white matter disease/stroke supplemented by research CT-brain imaging. Outcomes include length of hospitalisation, change in care needs, institutionalisation, mortality, readmission, longitudinal changes in cognitive and functional status and incident dementia. Biomarker associations with delirium, and with incident dementia on follow-up, will be determined using logistic or Cox regression as appropriate, unadjusted and adjusted for covariates including demographics, baseline cognition, frailty, comorbidity and apolipoprotein E genotype.
Ethics and dissemination
ORCHARD-PS is approved by the South Central—Berkshire Research Ethics Committee (REC Reference: 23/SC/0199). Results will be disseminated through peer-reviewed publications and conference presentations.
Trial registration number
ISRCTN24171810.
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