Status:
COMPLETED
Hip Fracture Surgery in Elderly Patients
Lead Sponsor:
Air Liquide Santé International
Collaborating Sponsors:
OptumInsight
Conditions:
Delirium
Eligibility:
All Genders
75+ years
Phase:
PHASE2
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 und...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
256 Patients enrolled
Trial Details
Trial ID
NCT01199276
Start Date
September 1 2010
End Date
October 1 2014
Last Update
July 27 2015
Active Locations (13)
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1
UZ Leuven
Leuven, Belgium, 3000
2
Centre Hospitalier Universitaire de Grenoble
La Tronche, France, 38700
3
Centre Hospitalier Régional Universitaire de Montpellier
Montpellier, France, 34295
4
Groupe Hospitalier La Pitié-Salpêtriere
Paris, France, 75651