Hip Fracture Surgery in Elderly Patients

Delirium Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01199276
• Other study ID #: ALMED-08-C2-020
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2010
• Last updated: July 24, 2015
• Start date: September 2010
• Est. completion date: October 2014

Study information

• Verified date: July 2015
• Source: Air Liquide Santé International
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesItaly: The Italian Medicines AgencySpain: Spanish Agency of MedicinesUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 75 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Delirium
• Hip Fractures

Intervention

Drug:
• Xenon
Group A: xenon 60% (55%-65%)(1 MAC) in oxygen (FiO2 = 0.35-0.45)
• Sevoflurane
Group B: sevoflurane 1.1-1.4%(1 MAC) in oxygen (FiO2 = 0.35-0.45) and Medical air

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven
France	Centre Hospitalier Universitaire de Grenoble	La Tronche
France	Centre Hospitalier Régional Universitaire de Montpellier	Montpellier
France	Groupe Hospitalier La Pitié-Salpêtriere	Paris
France	Groupe Hospitalier COCHIN	Paris cedex 14
France	CHU Pontchaillou - Université de Rennes 1	Rennes
France	Centre Hospitalier Universitaire de Toulouse	Toulouse
Germany	University Hospital Aachen	Aachen
Germany	. Klinik für Anästhesiologie - Universitätsklinikum Düsseldorf	Düsseldorf
Germany	Klinikum Mutterhaus Der Borromaerinnen	Trier
Italy	IRCCS Rizzoli Orthopaedic Institute	Bologna
Spain	Hospital Clinico Universitario de Valencia	Valencia
United Kingdom	Imperial College NHS Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Air Liquide Santé International	OptumInsight

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post Operative Delirium diagnosed with the Confusion Assessment Method within four days post-surgery		Four days	No
Secondary	Post Operative Delirium diagnosed with the Confusion Assessment Method from day 5 post surgery to discharge from hospital		About 7 days	No
Secondary	Sequential Organ Failure Assessment from day 1 to day 4 post-surgery		four days	No
Secondary	Recovery Parameters		fifteen minutes	No
Secondary	economic parameters		up to thirty days	No
Secondary	Safety Parameters	Serious Adverse Events, Adverse Events, laboratory parameters	Up to thirty days	Yes