Hip Fracture Surgery in Elderly Patients | Completed
Hip Fracture Surgery in Elderly Patients
HIPELD
Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Delirium
Unfortunately contact details are not available for this trial.
Primary Contact Details
Completed
Recruitment Status
NCT01199276
Primary Trial ID Number
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.
Research Details
    Sorry, this information is not available
Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Study Type
Interventional
Intervention
Drug : Xenon, Drug : Sevoflurane

Study Arm Groups : Xenon, Sevoflurane

Intervention Type
See Interventions above
Primary Outcome Measures
  • Post Operative Delirium diagnosed with the Confusion Assessment Method within four days post-surgery; Four days
Secondary Outcome Measures
  • Post Operative Delirium diagnosed with the Confusion Assessment Method from day 5 post surgery to discharge from hospital; About 7 days; Sequential Organ Failure Assessment from day 1 to day 4 post-surgery; four days; Recovery Parameters; fifteen minutes; economic parameters; up to thirty days; Safety Parameters; Up to thirty days
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
75 Years - N/A
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion 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
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
GSK Investigational Site
London
W2 1NY
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Belgium, France, Germany, Italy, Spain, United Kingdom
Scientific Title
An International, Multi-center, Randomized, Controlled Trial Evaluating The Effect of Xenon on Post-operative Delirium in Elderly Patients Undergoing Hip Fracture Surgery
EudraCT Number
Not available for this trial
Funder(s)
  • OptumInsight
Other Study ID Numbers
ALMED-08-C2-020
Sponsor(s)
Air Liquide Santé International
Key Dates

Recruitment Start Date

Sep 2010

Recruitment End Date

Oct 2014

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

09 Sep 2010

Last Updated

24 Jul 2015