Hip Fracture Surgery in Elderly Patients

NCT01199276 | Completed Phase 2

• 1 other identifier: ALMED-08-C2-020
• Study Type: interventional
• Target: 256
• Locations: 6 countries
• Sites: 13

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.

Conditions

Delirium

Keywords

Delirium; Hip Fracture; Elderly

Outcome Measures

Primary Outcomes (1)

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

  Four days

Secondary Outcomes (5)

• 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

Study Arms (2)

Xenon

EXPERIMENTAL

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

Drug: Xenon

Sevoflurane

ACTIVE COMPARATOR

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

Drug: Sevoflurane

Interventions

Xenon DRUG

Group A: xenon 60% (55%-65%)(1 MAC) in oxygen (FiO2 = 0.35-0.45)

Also known as: LENOXe

Xenon

Sevoflurane DRUG

Group B: sevoflurane 1.1-1.4%(1 MAC) in oxygen (FiO2 = 0.35-0.45) and Medical air

Sevoflurane

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Air Liquide Santé International: lead
• OptumInsight: collaborator

Study Sites (13)

UZ Leuven

Leuven, 3000, Belgium

Location

Centre Hospitalier Universitaire de Grenoble

La Tronche, 38700, France

Location

Centre Hospitalier Régional Universitaire de Montpellier

Montpellier, 34295, France

Location

Groupe Hospitalier La Pitié-Salpêtriere

Paris, 75651, France

Location

Groupe Hospitalier COCHIN

Paris, 75979, France

Location

CHU Pontchaillou - Université de Rennes 1

Rennes, 35033, France

Location

Centre Hospitalier Universitaire de Toulouse

Toulouse, 31059, France

Location

University Hospital Aachen

Aachen, 52074, Germany

Location

. Klinik für Anästhesiologie - Universitätsklinikum Düsseldorf

Düsseldorf, 40225, Germany

Location

Klinikum Mutterhaus Der Borromaerinnen

Trier, 54290, Germany

Location

IRCCS Rizzoli Orthopaedic Institute

Bologna, 40136, Italy

Location

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

Location

Imperial College NHS Trust

London, W2 1NY, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 29397119 DERIVED

• 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.

  PMID: 23016882 DERIVED

MeSH Terms

Conditions

Delirium; Hip Fractures

Interventions

Xenon; Sevoflurane

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Noble Gases; Elements; Inorganic Chemicals; Gases; Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2010
• First Posted: September 10, 2010
• Study Start: September 1, 2010
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: July 27, 2015

Record last verified: 2015-07

Locations

DE (3); GB (1); FR (6); BE (1); IT (1); ES (1)