Hip Fracture Surgery in Elderly Patients (HIPELD)
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| ClinicalTrials.gov Identifier: NCT01199276 |
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Recruitment Status :
Completed
First Posted : September 10, 2010
Last Update Posted : July 27, 2015
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Sponsor:
Air Liquide Santé International
Collaborator:
OptumInsight
Information provided by (Responsible Party):
Air Liquide Santé International
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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 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
| Arm | Intervention/treatment |
|---|---|
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Experimental: Xenon
60%(1MAC)in oxygen (FiO2 = 0.35-0.45)
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Drug: Xenon
Group A: xenon 60% (55%-65%)(1 MAC) in oxygen (FiO2 = 0.35-0.45)
Other Name: LENOXe |
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Active Comparator: Sevoflurane
1.1-1.4% (1 MAC) in oxygen (FiO2 = 0.35-0.45) and medical air
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Drug: Sevoflurane
Group B: sevoflurane 1.1-1.4%(1 MAC) in oxygen (FiO2 = 0.35-0.45) and Medical air |
Primary Outcome Measures :
- Post Operative Delirium diagnosed with the Confusion Assessment Method within four days post-surgery [ Time Frame: Four days ]
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 ]
- Sequential Organ Failure Assessment from day 1 to day 4 post-surgery [ Time Frame: four days ]
- Recovery Parameters [ Time Frame: fifteen minutes ]
- economic parameters [ Time Frame: up to thirty days ]
- Safety Parameters [ Time Frame: Up to thirty days ]Serious Adverse Events, Adverse Events, laboratory parameters
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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
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
| 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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |