Hip Fracture Surgery in Elderly Patients (HIPELD)

This study has been completed.
Information provided by (Responsible Party):
Air Liquide Santé International
ClinicalTrials.gov Identifier:
First received: September 9, 2010
Last updated: July 24, 2015
Last verified: July 2015
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 Intervention Phase
Drug: Xenon
Drug: Sevoflurane
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Further study details as provided by Air Liquide Santé International:

Primary Outcome Measures:
  • Post Operative Delirium diagnosed with the Confusion Assessment Method within four days post-surgery [ Time Frame: Four days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Post Operative Delirium diagnosed with the Confusion Assessment Method from day 5 post surgery to discharge from hospital [ Time Frame: About 7 days ] [ Designated as safety issue: No ]
  • Sequential Organ Failure Assessment from day 1 to day 4 post-surgery [ Time Frame: four days ] [ Designated as safety issue: No ]
  • Recovery Parameters [ Time Frame: fifteen minutes ] [ Designated as safety issue: No ]
  • economic parameters [ Time Frame: up to thirty days ] [ Designated as safety issue: No ]
  • Safety Parameters [ Time Frame: Up to thirty days ] [ Designated as safety issue: Yes ]
    Serious Adverse Events, Adverse Events, laboratory parameters

Enrollment: 256
Study Start Date: September 2010
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01199276

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Air Liquide Santé International
ClinicalTrials.gov Identifier: NCT01199276     History of Changes
Other Study ID Numbers: ALMED-08-C2-020 
Study First Received: September 9, 2010
Last Updated: July 24, 2015
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Italy: The Italian Medicines Agency
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Air Liquide Santé International:
Hip Fracture

Additional relevant MeSH terms:
Hip Fractures
Femoral Fractures
Fractures, Bone
Hip Injuries
Leg Injuries
Mental Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurocognitive Disorders
Neurologic Manifestations
Signs and Symptoms
Wounds and Injuries
Anesthetics, General
Anesthetics, Inhalation
Central Nervous System Depressants
Physiological Effects of Drugs
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on May 22, 2016