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The Hip Fracture Surgery in Elderly Patients (HIPELD) study: protocol for a randomized, multicenter controlled trial evaluating the effect of xenon on postoperative delirium in older patients undergoing hip fracture surgery.

ABSTRACT: Strategies to protect the brain from postoperative delirium (POD) after hip fracture are urgently needed. The development of delirium often is associated with the loss of independence, poor functional recovery, and increased morbidity, as well as increases in length of hospital stay, discharges to nursing facilities, and healthcare costs. We hypothesize that xenon may reduce the burden of POD, (i) by avoiding the need to provide anesthesia with a drug that targets the ?-amino-butyric acid (GABA)A receptor and (ii) through beneficial anesthetic and organ-protective effects.An international, multicenter, phase 2, prospective, randomized, blinded, parallel group and controlled trial to evaluate the incidence of POD, diagnosed with the Confusion Assessment Method (CAM), in older patients undergoing hip fracture surgery under general anesthesia with xenon or sevoflurane, for a period of 4 days post surgery (primary outcome) is planned. Secondary objectives are to compare the incidence of POD between xenon and sevoflurane, to evaluate the incidence of POD from day 5 post surgery until discharge from hospital, to determine the time to first POD diagnosis, to evaluate the duration of POD, to evaluate the evolution of the physiological status of the patients in the postoperative period, to evaluate the recovery parameters, to collect preliminary data to evaluate the economical impact of POD in the postoperative period and to collect safety data. Patients are eligible if they are older aged (? 75 years) and assigned to a planned hip fracture surgery within 48 h after the hip fracture. Furthermore, patients need to be willing and able to complete the requirements of this study including the signature of the written informed consent. A total of 256 randomized patients in the 10 participating centers will be recruited, that is, 128 randomized patients in each of the 2 study groups (receiving either xenon or sevoflurane).EudraCT Identifier: 2009-017153-35; ClinicalTrials.gov Identifier: NCT01199276.

SUBMITTER: Coburn M

PROVIDER: S-EPMC3488510 | biostudies-literature | 2012 Sep

REPOSITORIES: biostudies-literature

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The Hip Fracture Surgery in Elderly Patients (HIPELD) study: protocol for a randomized, multicenter controlled trial evaluating the effect of xenon on postoperative delirium in older patients undergoing hip fracture surgery.

Coburn Mark M Sanders Robert D RD Maze Mervyn M Rossaint Rolf R

Trials 20120927

<h4>Background</h4>Strategies to protect the brain from postoperative delirium (POD) after hip fracture are urgently needed. The development of delirium often is associated with the loss of independence, poor functional recovery, and increased morbidity, as well as increases in length of hospital stay, discharges to nursing facilities, and healthcare costs. We hypothesize that xenon may reduce the burden of POD, (i) by avoiding the need to provide anesthesia with a drug that targets the γ-amino- ...[more]

PMID: 23016882

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Project description:ObjectiveOlder patients with hip fractures who are undergoing surgery are at high risk of significant mortality and morbidity including postoperative delirium. It is unclear whether different types of anaesthesia may reduce the incidence of postoperative delirium. This systematic review will investigate the impact of anaesthetic technique on postoperative delirium. Other outcomes included mortality, length of stay, complications and functional outcomes.DesignSystematic review of randomised controlled trials and non-randomised controlled studies.Data sourcesBibliographic databases were searched from inception to June 2018. Web of Science and ZETOC databases were searched for conference proceedings. Reference lists of relevant articles were checked, and clinical trial registers were searched to identify ongoing trials.Eligibility criteriaStudies were eligible if general and regional anaesthesia were compared in patients (aged 60 and over) undergoing hip fracture surgery, reporting primary outcome of postoperative delirium and secondary outcomes of mortality, length of hospital stay, adverse events, functional outcomes, discharge location and quality of life. Exclusion criteria were anaesthetic technique or drug not considered current standard practice; patients undergoing hip fracture surgery alongside other surgery and uncontrolled studies.ResultsOne hundred and four studies were included. There was no evidence to suggest that anaesthesia type influences postoperative delirium or mortality. Some studies suggested a small reduction in length of hospital stay with regional anaesthesia. There was some evidence to suggest that respiratory complications and intraoperative hypotension were more common with general anaesthesia. Heterogeneity precluded meta-analysis. All findings were described narratively and data were presented where possible in forest plots for illustrative purposes.ConclusionsWhile there was no evidence to suggest that anaesthesia types influence postoperative delirium, the evidence base is lacking. There is a need to ascertain the impact of type of anaesthesia on outcomes with an adequately powered, methodologically rigorous study.Prospero registration numberCRD42015020166.

Project description:IntroductionPostoperative delirium is a common complication of patients undergoing hip fracture surgery or arthroplasty and is related to decreased survival time and physical function. In this study, we aim to build and validate a prediction score of postoperative delirium in geriatric patients undergoing hip fracture surgery or hip arthroplasty.MethodsA retrospective cohort of geriatric patients undergoing hip fracture surgery or hip arthroplasty was established. Variables of included patients were collected as candidate predictors of postoperative delirium. The least absolute shrinkage and selection operator (LASSO) regression and logistic regression were used to derive a predictive score for postoperative delirium. The accuracy of the score was evaluated by the area under the curve (AUC) of the receiver operating curve (ROC). We used bootstrapping resamples for model calibration. The prediction score was validated in an extra cohort.ResultsThere were 1,312 patients in the derivation cohort, and the incidence of postoperative delirium was 14.33%. Of 40 variables, 9 were identified as predictors, including preoperative delirium, cerebrovascular accident (CVA) with the modified Rankin scale, diabetes with a random glucose level, Charlson comorbidity index (CCI), age, application of benzodiazepines in surgery, surgical delay ≥2 days, creatine ≥90 μmol/L, and active smoker. The prediction score achieved a mean AUC of 0.848 in the derivation cohort. In the validation cohort, the mean AUC was 0.833. The prediction model was well-calibrated in the two cohorts.ConclusionBased on retrospective data, a prediction score for postoperative delirium in geriatric patients undergoing hip fracture surgery or hip arthroplasty was derived and validated. The performance of the scoring system outperformed the models from previous studies. Although the generalization ability of the score needs to be tested in similar populations, the scoring system will enable delirium risk stratification for hip fracture patients and facilitate the development of strategies for delirium prevention.

Project description:BackgroundCircadian rhythm disturbance is common postoperatively in older patients with hip fractures, which may contribute to the development of postoperative delirium (POD). As a reliable biomarker of endogenous circadian rhythms, melatonin regulates the sleep-wake cycle and environmental adaptation, and its secretory rhythm may be modified by anaesthesia and surgery. This study compared the impact of subarachnoid anaesthesia (SA) and general anaesthesia (GA), on the peak of melatonin secretion (primary outcome), the circadian rhythm of melatonin, cortisol and sleep, and the POD incidence (secondary outcome).MethodsIn this prospective cohort observational study, hip fracture surgery patients were enrolled and assigned to receive either SA or GA. Postoperative plasma melatonin and cortisol levels were dynamically measured every six hours on seven time-points, and the circadian rhythm parameters including mesor, amplitude, and acrophase were calculated. Subjective and objective sleep assessments were performed by sleep diaries and sleep trackers, respectively. The Confusion Assessment Method was used twice daily by a specific geriatrician to screen for POD occurrence.FindingsIn a cohort of 138 patients who underwent hip fracture surgery, the circadian rhythm disruption of the patients in the GA group (n=69) was greater than the SA group (n=69). Compared with SA, GA provided the lower peak concentration, mesor, and amplitude of melatonin secretion on postoperative day 1 (p < 0.05). Patients in the GA group experienced higher awakenings, more sleep deprivation, and poor sleep quality on surgery day (p < 0.05). A proportion of 12 patients in the SA group (17.4%) and 24 patients in the GA group (34.8%) experienced POD (p = 0.020).InterpretationThese results suggest that SA may be superior to GA in elderly patients undergoing hip fracture surgery as SA is associated with less impairment of the melatonin rhythm and sleep patterns, and fewer POD occurrences.FundingThe study was supported by the National Natural Science Foundation of China (81971012, 81873726, 81901095, 81701052, and 81801070), Key Clinical Projects of Peking University Third Hospital (BYSYZD2019027), and Peking University "Clinical Medicine plus X" Youth Project (PKU2020LCXQ016).

Project description:ObjectiveTo investigate dysregulated molecules in preoperative cerebrospinal fluid (CSF) of elderly hip fracture patients with postoperative delirium (POD), in order to identify potential pathological mechanisms and biomarkers for pre-stage POD.Materials and methodsThis nested case control study used untargeted metabolomic and lipidomic analysis to profile the preoperative CSF of patients (n = 40) who developed POD undergone hip fracture surgery (n = 10) and those who did not (n = 30). Thirty Non-POD patients were matched to 10 POD patients by age (± 2 years) and Mini Mental State Examination score (± 2 points). CSF was collected after successful spinal anesthesia and banked for subsequent analysis. On the first two postoperative days, patients were assessed twice daily using the Confusion Assessment Method-Chinese Revision. CSF samples from the two groups were analyzed to investigate possible relevant pathological mechanisms and identify candidate biomarkers.ResultsDemographic characteristics of the groups were matched. Eighteen metabolites and thirty-three lipids were dysregulated in the preoperative CSF of POD patients. Pathway enrichment analysis revealed perturbations in D-glutamine and D-glutamate metabolism; glycerophospholipid metabolism; alanine, aspartate and glutamate metabolism; sphingolipid metabolism; histidine metabolism; and arginine biosynthesis at the pre-delirium stage. Receiver operating characteristic curve analysis indicated that phosphatidylethanolamine (PE, 40:7e), with an area under the curve value of 0.92, is a potential biomarker for POD.ConclusionMultiple pathological mechanisms in the POD group were involved before surgery, including neuroinflammation, oxidative stress, and energy metabolism disorders induced by hypoxia, as well as neurotransmitter imbalances such as increased dopamine and glutamate, and decreased glutamine. These metabolic abnormalities potentially increase the fragility of the brain, thus contributing to POD. PE (40:7e) might be a potential biomarker for POD. Not only do our results provide potential biomarkers for POD, but also provide information for deep pathological research.Clinical trial registrationwww.ClinicalTrials.gov, identifier ChiCTR1900021533.

Project description:This study aimed to determine the relationship between hemoglobin (Hb) concentration and post-operative delirium (POD) in elderly patients undergoing femoral neck fracture (FNF) surgery and to investigate whether the change in Hb concentration is associated with POD and the risk factors for POD. A total of 889 patients admitted with FNF between January 2016 and December 2020 were enrolled in this single-center, retrospective, case-control study. Hb concentrations were determined at admission and post-operative day 1 and the change in Hb concentration was defined as the absolute value of difference in pre-operative and post-operative Hb concentration. POD was assessed using the Confusion Assessment Method for the Intensive Care Unit (ICU) or the Confusion Assessment Method once a daily after surgery. The logistic regression analysis was performed for statistical analysis. In total, 172 (19.3%) patients developed POD and 151 (87.8%) patients developed POD within post-operative 3 days. Low pre-operative Hb concentration [p = 0.026, odds ratio (OR) = 0.978] and significant change in Hb concentration (p = 0.006, OR = 1.033) were significantly associated with POD. After excluding change in Hb concentration or pre-operative Hb concentration, neither of them was significantly associated with POD (p > 0.05). The interaction analysis of change in Hb concentration and pre-operative Hb concentration in the logistic regression model was negative. There was no significant relationship between post-operative Hb concentration and POD. Age (p < 0.001, OR = 1.072), stroke history (p = 0.003, OR = 2.489), post-operative ICU transfer (p = 0.007, OR = 1.981), and visual analog scale score within post-operative 2 days (p 1 = 0.016 and p 2 = 0.006) were independently associated with POD in the logistic regression analysis. Patients with low pre-operative Hb concentrations and high changes in Hb concentration seem to have an increased risk of POD and should receive more attention. Old age, stroke history, post-operative ICU transfer, and pain within post-operative 2 days were significantly associated with POD.

Dataset Information

The Hip Fracture Surgery in Elderly Patients (HIPELD) study: protocol for a randomized, multicenter controlled trial evaluating the effect of xenon on postoperative delirium in older patients undergoing hip fracture surgery.

Publications

The Hip Fracture Surgery in Elderly Patients (HIPELD) study: protocol for a randomized, multicenter controlled trial evaluating the effect of xenon on postoperative delirium in older patients undergoing hip fracture surgery.

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