Hip Fracture Surgery in Elderly Patients (HIPELD)

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Delirium	Drug: Xenon; Drug: Sevoflurane	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	256 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
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 Start Date :	September 2010
Actual Primary Completion Date :	October 2014
Actual Study Completion Date :	October 2014

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Xenon; 60%(1MAC)in oxygen (FiO2 = 0.35-0.45)	Drug: Xenon; Group A: xenon 60% (55%-65%)(1 MAC) in oxygen (FiO2 = 0.35-0.45); Other Name: LENOXe
Active Comparator: Sevoflurane; 1.1-1.4% (1 MAC) in oxygen (FiO2 = 0.35-0.45) and medical air	Drug: Sevoflurane; Group B: sevoflurane 1.1-1.4%(1 MAC) in oxygen (FiO2 = 0.35-0.45) and Medical air

Outcome Measures

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Primary Outcome Measures :

1. Post Operative Delirium diagnosed with the Confusion Assessment Method within four days post-surgery [ Time Frame: Four days ]

Secondary Outcome Measures :

1. Post Operative Delirium diagnosed with the Confusion Assessment Method from day 5 post surgery to discharge from hospital [ Time Frame: About 7 days ]
2. Sequential Organ Failure Assessment from day 1 to day 4 post-surgery [ Time Frame: four days ]
3. Recovery Parameters [ Time Frame: fifteen minutes ]
4. economic parameters [ Time Frame: up to thirty days ]
5. Safety Parameters [ Time Frame: Up to thirty days ]
   Serious Adverse Events, Adverse Events, laboratory parameters

Eligibility Criteria

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Ages Eligible for Study:	75 Years and older (Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

Belgium
UZ Leuven
Leuven, Belgium, 3000
France
Centre Hospitalier Universitaire de Grenoble
La Tronche, France, 38700
Centre Hospitalier Régional Universitaire de Montpellier
Montpellier, France, 34295
Groupe Hospitalier COCHIN
Paris cedex 14, France, 75979
Groupe Hospitalier La Pitié-Salpêtriere
Paris, France, 75651
CHU Pontchaillou - Université de Rennes 1
Rennes, France, 35033
Centre Hospitalier Universitaire de Toulouse
Toulouse, France, 31059
Germany
University Hospital Aachen
Aachen, Germany, 52074
. Klinik für Anästhesiologie - Universitätsklinikum Düsseldorf
Düsseldorf, Germany, 40225
Klinikum Mutterhaus Der Borromaerinnen
Trier, Germany, 54290
Italy
IRCCS Rizzoli Orthopaedic Institute
Bologna, Italy, 40136
Spain
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
United Kingdom
Imperial College NHS Trust
London, United Kingdom, W2 1NY

Sponsors and Collaborators

Air Liquide Santé International

OptumInsight

Investigators

Study Chair:	Mark COBURN, MD	University Hospital Aachen - Germany
Study Chair:	Robert SANDERS, MD	Imperial College London - UK
Study Chair:	Rolf ROSSAINT, MD	University Hospital Aachen - Germany

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Coburn M, Sanders RD, Maze M, Nguyên-Pascal ML, Rex S, Garrigues B, Carbonell JA, Garcia-Perez ML, Stevanovic A, Kienbaum P, Neukirchen M, Schaefer MS, Borghi B, van Oven H, Tognù 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.

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.

Responsible Party:	Air Liquide Santé International
ClinicalTrials.gov Identifier:	NCT01199276 History of Changes
Other Study ID Numbers:	ALMED-08-C2-020
First Posted:	September 10, 2010
Last Update Posted:	July 27, 2015
Last Verified:	July 2015

Keywords provided by Air Liquide Santé International:

Delirium; Hip Fracture; Elderly

Additional relevant MeSH terms:

Delirium; Hip Fractures; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Femoral Fractures; Fractures, Bone	Wounds and Injuries; Hip Injuries; Leg Injuries; Sevoflurane; Xenon; Platelet Aggregation Inhibitors; Anesthetics, Inhalation; Anesthetics, General; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs