Hip Fracture Surgery in Elderly Patients (HIPELD)
This study is currently recruiting participants.
Verified May 2013 by Air Liquide Santé International
Sponsor:
Air Liquide Santé International
Collaborator:
OptumInsight
Information provided by (Responsible Party):
Air Liquide Santé International
ClinicalTrials.gov Identifier:
NCT01199276
First received: September 9, 2010
Last updated: May 15, 2013
Last verified: May 2013
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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: | February 2014 |
| Estimated Primary Completion Date: | December 2013 (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
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 | Active, not recruiting |
| Paris, France, 75651 | |
| 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 | Active, not recruiting |
| Rennes, France, 35033 | |
| 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 | Recruiting |
| Valencia, Spain, 46010 | |
| Contact: Javier BELDA, MD fjbelda@uv.es | |
| Contact: Beatriz GARRIGUES, MD | |
| Principal Investigator: Javier BELDA, MD | |
| 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: | May 15, 2013 |
| 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 May 19, 2013