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.
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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老年患者（HIPELD）研究的髋部骨折手术：一项随机多中心对照试验的方案，该试验评估了氙气对髋部骨折手术的老年患者的术后del妄的影响。
DOI：
10.1186/1745-6215-13-180
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发表时间：
2012-09-27
期刊：
影响因子：
2.5
通讯作者：
HIPELD Investigators
中科院分区：
文献类型：
--
作者：
Coburn M;Sanders RD;Maze M;Rossaint R;HIPELD Investigators
目前迫切需要保护髋部骨折后大脑免受术后谵妄（POD）的策略。谵妄的发生通常与丧失独立性、功能恢复不良和发病率增加以及住院时间、出院到护理机构和医疗保健费用增加有关。我们假设氙可以减少POD的负担，（i）通过避免需要使用靶向γ-氨基丁酸（GABA）A受体的药物进行麻醉，（ii）通过有益的麻醉和器官保护作用。计划进行一项国际、多中心、II期、前瞻性、随机、设盲、平行组和对照试验，以评价在氙气或七氟烷全麻下接受髋部骨折手术的老年患者中术后4天（主要结局）经混淆评估方法（CAM）诊断的POD的发生率。次要目的是比较氙气和七氟烷之间的POD发生率，评价从术后第5天至出院的POD发生率，确定至首次POD诊断的时间，评价POD持续时间，评价术后患者生理状态的演变，评价恢复参数，收集初步数据，以评价术后POD的经济影响，并收集安全性数据。如果患者年龄较大（≥ 75岁），并且在髋部骨折后48小时内被分配接受计划的髋部骨折手术，则患者合格。此外，患者需要愿意并能够完成本研究的要求，包括签署书面知情同意书。将在10家参与研究中心共招募256例随机化患者，即2个研究组（接受氙气或七氟烷）各招募128例随机化患者。EudraCT标识符：2009-017153-35; ClinicalTrials.gov标识符：NCT 01199276
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-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
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影响因子：
6.3
作者：
Ma, DQ;Hossain, M;Maze, M
通讯作者：
Maze, M
影响因子：
4.7
作者：
Sanders, Robert D.
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Sanders, Robert D.
影响因子：
8.8
作者：
Pandharipande, Pratik P.;Shintani, Ayumi K.;Ely, E. Wesley
通讯作者：
Ely, E. Wesley
影响因子：
9.8
作者：
Coburn, M;Kunitz, O;Rossaint, R
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Rossaint, R
影响因子：
2.5
作者：
Rajakumaraswamy, Nishanthan;Ma, Daqing;Maze, Mervyn
通讯作者：
Maze, Mervyn