Hip Fracture Surgery in Elderly Patients (HIPELD)

An International, Multi-center, Randomized, Controlled Trial Evaluating The Effect of Xenon on Post-operative Delirium in Elderly Patients Undergoing Hip Fracture Surgery

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.

Study Overview

• Status: Completed
• Conditions: Delirium
• Intervention / Treatment: Drug: Xenon; Drug: Sevoflurane

• Study Type: Interventional
• Enrollment (Actual): 256
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • UZ Leuven
• France
  • La Tronche, France, 38700
    • Centre Hospitalier Universitaire de Grenoble
  • Montpellier, France, 34295
    • Centre Hospitalier Régional Universitaire de Montpellier
  • Paris, France, 75651
    • Groupe Hospitalier La Pitie-Salpetriere
  • Paris cedex 14, France, 75979
    • Groupe Hospitalier Cochin
  • Rennes, France, 35033
    • CHU Pontchaillou - Université de Rennes 1
  • Toulouse, France, 31059
    • Centre Hospitalier Universitaire de Toulouse
• Germany
  • Aachen, Germany, 52074
    • University Hospital Aachen
  • Düsseldorf, Germany, 40225
    • . Klinik für Anästhesiologie - Universitätsklinikum Düsseldorf
  • Trier, Germany, 54290
    • Klinikum Mutterhaus der Borromäerinnen
• Italy
  • Bologna, Italy, 40136
    • IRCCS Rizzoli Orthopaedic Institute
• Spain
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario de Valencia
• United Kingdom
  • London, United Kingdom, W2 1NY
    • Imperial College NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Post Operative Delirium diagnosed with the Confusion Assessment Method within four days post-surgery	Four days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Serious Adverse Events, Adverse Events, laboratory parameters	Up to thirty days

Collaborators and Investigators

• Sponsor: Air Liquide Santé International
• Collaborators: 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 and helpful links

General Publications

• Coburn M, Sanders RD, Maze M, Nguyen-Pascal ML, Rex S, Garrigues B, Carbonell JA, Garcia-Perez ML, Stevanovic A, Kienbaum P, Neukirchen M, Schaefer MS, Borghi B, van Oven H, Tognu A, Al Tmimi L, Eyrolle L, Langeron O, Capdevila X, Arnold GM, Schaller M, Rossaint R; HIPELD Study Investigators. The hip fracture surgery in elderly patients (HIPELD) study to evaluate xenon anaesthesia for the prevention of postoperative delirium: a multicentre, randomized clinical trial. Br J Anaesth. 2018 Jan;120(1):127-137. doi: 10.1016/j.bja.2017.11.015. Epub 2017 Nov 21.
• Coburn M, Sanders RD, Maze M, Rossaint R; HIPELD Investigators. The Hip Fracture Surgery in Elderly Patients (HIPELD) study: protocol for a randomized, multicenter controlled trial evaluating the effect of xenon on postoperative delirium in older patients undergoing hip fracture surgery. Trials. 2012 Sep 27;13:180. doi: 10.1186/1745-6215-13-180.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: September 9, 2010
• First Submitted That Met QC Criteria: September 9, 2010
• First Posted (Estimate): September 10, 2010

Study Record Updates

• Last Update Posted (Estimate): July 27, 2015
• Last Update Submitted That Met QC Criteria: July 24, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Elderly; Hip Fracture; Delirium
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Fractures, Bone; Wounds and Injuries; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Leg Injuries; Femoral Fractures; Hip Injuries; Delirium; Hip Fractures; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Anesthetics, Inhalation; Sevoflurane
• Other Study ID Numbers: ALMED-08-C2-020