Clinical trial NCT01199276: Hip Fracture Surgery in Elderly Patients
Official title: An International, Multi-center, Randomized, Controlled Trial Evaluating The Effect of Xenon on Post-operative Delirium in Elderly Patients Undergoing Hip Fracture Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Delirium
Keywords: Delirium
Hip Fracture
Elderly
Lead sponsor: Air Liquide Santé International
Sponsor class: INDUSTRY
Collaborators: name: OptumInsight
First posted: 2010-09-10
Enrollment: 256
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the incidence of Post-Operative Delirium (POD), diagnosed with the Confusion Assessment Method (CAM), in elderly patients undergoing hip fracture surgery under general anaesthesia with xenon or sevoflurane, for a period of four days post-surgery.


Eligibility criteria: Inclusion Criteria:

* Elderly patient (≥ 75 years)
* Patient 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

Exclusion Criteria:

* Patient suffering from multiple fractures, pelvic fractures proximal, pathological fractures, femur fractures (i.e., fractures of the middle or 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
* Patient who cannot complete the pre-operative mental tests (CAM and/or MMSE) of this clinical trial
* Patient with Mini-Mental State Examination (MMSE) score \< 24 at selection
* 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
* Contra-indication (serious illness or medical conditions) for general anaesthesia
* Known allergy or hypersensitivity to any drugs administered during this clinical trial
* Previous participation in this 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

Primary outcomes:
measure: Post Operative Delirium diagnosed with the Confusion Assessment Method within four days post-surgery
timeFrame: Four days
Secondary outcomes:
measure: Post Operative Delirium diagnosed with the Confusion Assessment Method from day 5 post surgery to discharge from hospital
timeFrame: About 7 days
measure: Sequential Organ Failure Assessment from day 1 to day 4 post-surgery
timeFrame: four days
measure: Recovery Parameters
timeFrame: fifteen minutes
measure: economic parameters
timeFrame: up to thirty days
measure: Safety Parameters
timeFrame: Up to thirty days
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
city: La Tronche
country: France
facility: Centre Hospitalier Universitaire de Grenoble
city: Montpellier
country: France
facility: Centre Hospitalier Régional Universitaire de Montpellier
city: Paris cedex 14
country: France
facility: Groupe Hospitalier COCHIN
city: Paris
country: France
facility: Groupe Hospitalier La Pitié-Salpêtriere
city: Rennes
country: France
facility: CHU Pontchaillou - Université de Rennes 1
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire de Toulouse
city: Aachen
country: Germany
facility: University Hospital Aachen
city: Düsseldorf
country: Germany
facility: . Klinik für Anästhesiologie - Universitätsklinikum Düsseldorf
city: Trier
country: Germany
facility: Klinikum Mutterhaus Der Borromaerinnen
city: Bologna
country: Italy
facility: IRCCS Rizzoli Orthopaedic Institute
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: London
country: United Kingdom
facility: Imperial College NHS Trust
Study officials:
affiliation: University Hospital Aachen - Germany
name: Mark COBURN, MD
role: STUDY_CHAIR
affiliation: Imperial College London - UK
name: Robert SANDERS, MD
role: STUDY_CHAIR
affiliation: University Hospital Aachen - Germany
name: Rolf ROSSAINT, MD
role: STUDY_CHAIR
References:
citation: Coburn M, Sanders RD, Maze M, Nguyen-Pascal ML, Rex S, Garrigues B, Carbonell JA, Garcia-Perez ML, Stevanovic A, Kienbaum P, Neukirchen M, Schaefer MS, Borghi B, van Oven H, Tognu A, Al Tmimi L, Eyrolle L, Langeron O, Capdevila X, Arnold GM, Schaller M, Rossaint R; HIPELD Study Investigators. The hip fracture surgery in elderly patients (HIPELD) study to evaluate xenon anaesthesia for the prevention of postoperative delirium: a multicentre, randomized clinical trial. Br J Anaesth. 2018 Jan;120(1):127-137. doi: 10.1016/j.bja.2017.11.015. Epub 2017 Nov 21.
citation: Coburn M, Sanders RD, Maze M, Rossaint R; HIPELD Investigators. 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. Trials. 2012 Sep 27;13:180. doi: 10.1186/1745-6215-13-180.