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Hip Fracture Surgery in Elderly Patients (HIPELD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01199276
Recruitment Status : Completed
First Posted : September 10, 2010
Last Update Posted : July 27, 2015
Sponsor:
Collaborator:
OptumInsight
Information provided by (Responsible Party):
Air Liquide Santé International

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

Resource links provided by the National Library of Medicine


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   (Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01199276


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

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Responsible Party: Air Liquide Santé International
ClinicalTrials.gov Identifier: NCT01199276    
Other Study ID Numbers: ALMED-08-C2-020
First Posted: September 10, 2010    Key Record Dates
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:
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Delirium
Hip Fractures
Fractures, Bone
Wounds and Injuries
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
 Femoral Fractures
Hip Injuries
Leg Injuries
Sevoflurane
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs