EUCTR2009-017153-35-BE进行中（未招募）不适用
An international, multi-center, randomized, controlled trial evaluating the effect of xenon on post-operative delirium in elderly patients undergoing hip fracture surgery. - Hip fracture surgery in elderly patients - HIPELD
AIR LIQUIDE SANTE INTERNATIONA0 个研究点目标入组 256 人开始时间: 2012年12月13日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 256
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Elderly patient (= 75 years).
- •- Patients with planned hip fracture surgery within 48 hours after the hip fracture.
- •- Patient willing and able to complete the requirements of this study including the signature of the written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 256
排除标准
- •- Patient suffering of multiple fractures, pelvic fractures proximal, pathological fractures, femur fractures (ie fracture of the middle and distal femur).
- •- Disabling neuropsychiatric disorders (severe dementia, Alzheimer’s disease, schizophrenia, depression).
- •- Brain trauma within 12 months prior to selection, history of stroke with residuals.
- •- Patient suffering from delirium (CAM diagnosis) at selection.
- •- Patients who cannot complete the pre-operative mental tests of this current clinical trial
- •- Patients with Mini-Mental State Examination (MMSE) score < 24 at selection.
- •- Contra-indication (serious illness or medical conditions) for general anaesthesia .
- •- Known allergy or hypersensitivity to any drugs administered during the current clinical trial.
- •- Previous participation in this current clinical trial.
- •- Participation in another clinical trial within 4 weeks prior to selection.
- •- History of alcohol or drug abuse or psychiatric disorders which would impair the understanding of the necessary information or render medically or legally unable to give written informed consent.
- •- Patient known to susceptible to malignant hyperthermia.
- •- Patient with elevated intra-cranial pressure.
- •- Patient with a risk of high oxygen demand.
- •- Patient with recent or ongoing myocardial infarction / damage.
- •- Patient with severe cardiac failure, or patient with severe impaired left ventricular systolic function.
- •- Patient with known severe lung and/or airway disease, or severe chronic respiratory insufficiency, or a sustained homecare oxygen therapy.
研究者
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