Hip Fracture Surgery in Elderly Patients (HIPELD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Air Liquide Santé International
Sponsor:
Collaborator:
OptumInsight
Information provided by (Responsible Party):
Air Liquide Santé International
ClinicalTrials.gov Identifier:
NCT01199276
First received: September 9, 2010
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

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
Delirium
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


Estimated Enrollment: 256
Study Start Date: September 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: May 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

  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Joel GUITTET +33 1 39 07 20 68 joel.guittet@airliquide.com

Locations
Belgium
UZ Leuven Recruiting
Leuven, Belgium, 3000
Contact: Steffen REX, MD    +32 16 34 13 74    steffen.rex@uzleuven.be   
Principal Investigator: Steffen REX, MD         
France
Centre Hospitalier Universitaire de Grenoble Recruiting
La Tronche, France, 38700
Contact: Pierre ALBALADEJO, MD         
Principal Investigator: Pierre ALBALADEJO, MD         
Centre Hospitalier Régional Universitaire de Montpellier Recruiting
Montpellier, France, 34295
Contact: Xavier CAPDEVILA, Professeur         
Principal Investigator: Xavier CAPDEVILA, MD         
Groupe Hospitalier La Pitié-Salpêtriere Recruiting
Paris, France, 75651
Contact: Olivier LANGERON, MD    +33 1 42 17 73 29    olivier.langeron@psl.aphp.fr   
Principal Investigator: Olivier LANGERON, MD         
Groupe Hospitalier COCHIN Recruiting
Paris cedex 14, France, 75979
Contact: Nadia ROSENCHER, MD       nadia.rosencher@cch.aphp.fr   
Contact: Hadrien REYRE, MD         
Principal Investigator: Nadia ROSENCHER, MD         
CHU Pontchaillou - Université de Rennes 1 Recruiting
Rennes, France, 35033
Contact: Hélène BELOEIL, MD    +33 2 99 28 42 00    helene.beloeil@chu-rennes.fr   
Principal Investigator: Hélène BELOEIL, MD         
Centre Hospitalier Universitaire de Toulouse Recruiting
Toulouse, France, 31059
Contact: Vincent MINVILLE, MD         
Principal Investigator: Vincent MINVILLE, MD         
Germany
University Hospital Aachen Recruiting
Aachen, Germany, 52074
Contact: Rolf ROSSAINT, MD    +49 241 80 88179    anaesthesiologie@ukaachen.de   
Contact: Mark COBURN, MD    +49 (241) 8035394    mcoburn@ukaachen.de   
Principal Investigator: Rolf ROSSAINT, MD         
. Klinik für Anästhesiologie - Universitätsklinikum Düsseldorf Recruiting
Düsseldorf, Germany, 40225
Contact: Peter KIENBAUM, Prof.Dr.med         
Principal Investigator: Peter KIENBAUM, Prof.med.Dr         
Klinikum Mutterhaus Der Borromaerinnen Recruiting
Trier, Germany, 54290
Contact: Oliver KUNITZ, Dr         
Principal Investigator: Oliver KUNITZ, Dr         
Italy
IRCCS Rizzoli Orthopaedic Institute Recruiting
Bologna, Italy, 40136
Contact: Battista BORGHI, MD       battista.borghi@ior.it   
Principal Investigator: Battista BORGHI, MD         
Spain
Hospital Clinico Universitario de Valencia Active, not recruiting
Valencia, Spain, 46010
United Kingdom
Imperial College NHS Trust Recruiting
London, United Kingdom, W2 1NY
Contact: Glenn ARNOLD, MD       g.arnold@nhs.net   
Principal Investigator: Glenn ARNOLD, MD         
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

No publications provided by Air Liquide Santé International

Additional 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: January 27, 2014
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:
Delirium
Hip Fracture
Elderly

Additional relevant MeSH terms:
Delirium
Hip Fractures
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries
Xenon
Sevoflurane
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Platelet Aggregation Inhibitors
Hematologic Agents

ClinicalTrials.gov processed this record on July 20, 2014