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Hip Fracture Surgery in Elderly Patients (HIPELD)

Primary Purpose

Delirium

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Xenon
Sevoflurane
Sponsored by
Air Liquide Santé International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Delirium focused on measuring Delirium, Hip Fracture, Elderly

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UZ Leuven
  • Centre Hospitalier Universitaire de Grenoble
  • Centre Hospitalier Régional Universitaire de Montpellier
  • Groupe Hospitalier COCHIN
  • Groupe Hospitalier La Pitié-Salpêtriere
  • CHU Pontchaillou - Université de Rennes 1
  • Centre Hospitalier Universitaire de Toulouse
  • University Hospital Aachen
  • . Klinik für Anästhesiologie - Universitätsklinikum Düsseldorf
  • Klinikum Mutterhaus Der Borromaerinnen
  • IRCCS Rizzoli Orthopaedic Institute
  • Hospital Clinico Universitario de Valencia
  • Imperial College NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Xenon

Sevoflurane

Arm Description

60%(1MAC)in oxygen (FiO2 = 0.35-0.45)

1.1-1.4% (1 MAC) in oxygen (FiO2 = 0.35-0.45) and medical air

Outcomes

Primary Outcome Measures

Post Operative Delirium diagnosed with the Confusion Assessment Method within four days post-surgery

Secondary Outcome Measures

Post Operative Delirium diagnosed with the Confusion Assessment Method from day 5 post surgery to discharge from hospital
Sequential Organ Failure Assessment from day 1 to day 4 post-surgery
Recovery Parameters
economic parameters
Safety Parameters
Serious Adverse Events, Adverse Events, laboratory parameters

Full Information

First Posted
September 9, 2010
Last Updated
July 24, 2015
Sponsor
Air Liquide Santé International
Collaborators
OptumInsight
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1. Study Identification

Unique Protocol Identification Number
NCT01199276
Brief Title
Hip Fracture Surgery in Elderly Patients
Acronym
HIPELD
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 Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Air Liquide Santé International
Collaborators
OptumInsight

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium
Keywords
Delirium, Hip Fracture, Elderly

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
256 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Xenon
Arm Type
Experimental
Arm Description
60%(1MAC)in oxygen (FiO2 = 0.35-0.45)
Arm Title
Sevoflurane
Arm Type
Active Comparator
Arm Description
1.1-1.4% (1 MAC) in oxygen (FiO2 = 0.35-0.45) and medical air
Intervention Type
Drug
Intervention Name(s)
Xenon
Other Intervention Name(s)
LENOXe
Intervention Description
Group A: xenon 60% (55%-65%)(1 MAC) in oxygen (FiO2 = 0.35-0.45)
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Intervention Description
Group B: sevoflurane 1.1-1.4%(1 MAC) in oxygen (FiO2 = 0.35-0.45) and Medical air
Primary Outcome Measure Information:
Title
Post Operative Delirium diagnosed with the Confusion Assessment Method within four days post-surgery
Time Frame
Four days
Secondary Outcome Measure Information:
Title
Post Operative Delirium diagnosed with the Confusion Assessment Method from day 5 post surgery to discharge from hospital
Time Frame
About 7 days
Title
Sequential Organ Failure Assessment from day 1 to day 4 post-surgery
Time Frame
four days
Title
Recovery Parameters
Time Frame
fifteen minutes
Title
economic parameters
Time Frame
up to thirty days
Title
Safety Parameters
Description
Serious Adverse Events, Adverse Events, laboratory parameters
Time Frame
Up to thirty days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark COBURN, MD
Organizational Affiliation
University Hospital Aachen - Germany
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Robert SANDERS, MD
Organizational Affiliation
Imperial College London - UK
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Rolf ROSSAINT, MD
Organizational Affiliation
University Hospital Aachen - Germany
Official's Role
Study Chair
Facility Information:
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Centre Hospitalier Universitaire de Grenoble
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
Centre Hospitalier Régional Universitaire de Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Groupe Hospitalier COCHIN
City
Paris cedex 14
ZIP/Postal Code
75979
Country
France
Facility Name
Groupe Hospitalier La Pitié-Salpêtriere
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
CHU Pontchaillou - Université de Rennes 1
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Centre Hospitalier Universitaire de Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
University Hospital Aachen
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
. Klinik für Anästhesiologie - Universitätsklinikum Düsseldorf
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Klinikum Mutterhaus Der Borromaerinnen
City
Trier
ZIP/Postal Code
54290
Country
Germany
Facility Name
IRCCS Rizzoli Orthopaedic Institute
City
Bologna
ZIP/Postal Code
40136
Country
Italy
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Imperial College NHS Trust
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
29397119
Citation
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.
Results Reference
derived
PubMed Identifier
23016882
Citation
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.
Results Reference
derived

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Hip Fracture Surgery in Elderly Patients

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