DeliriumPhase 2HIPELDNCT01199276
Hip Fracture Surgery in Elderly Patients
A Phase 2 study testing Xenon and Sevoflurane in people with Delirium, run by Air Liquide Santé International at 13 sites in 6 countries.
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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Delirium
- What is being tested?
- Xenon and Sevoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 13 sitesin 6 countries
- Study dates
- Sep 2010to Oct 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
13 sites in 6 countries.
13 sites in 6 countries
France6 sites
Centre Hospitalier Universitaire de Grenoble
La Tronche, 38700
Centre Hospitalier Régional Universitaire de Montpellier
Montpellier, 34295
Groupe Hospitalier La Pitié-Salpêtriere
Paris, 75651
Groupe Hospitalier COCHIN
Paris, 75979
CHU Pontchaillou - Université de Rennes 1
Rennes, 35033
Centre Hospitalier Universitaire de Toulouse
Toulouse, 31059
Germany3 sites
University Hospital Aachen
Aachen, 52074
. Klinik für Anästhesiologie - Universitätsklinikum Düsseldorf
Düsseldorf, 40225
Klinikum Mutterhaus Der Borromaerinnen
Trier, 54290
About this study
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
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
- Being tested
- Xenon, Sevoflurane
- Keywords
- Delirium, Hip Fracture, Elderly
- Medical subject headings
- Delirium, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XenonDrug
Also called LENOXe
Group A: xenon 60% (55%-65%)(1 MAC) in oxygen (FiO2 = 0.35-0.45)
SevofluraneDrug
Group B: sevoflurane 1.1-1.4%(1 MAC) in oxygen (FiO2 = 0.35-0.45) and Medical air
| Study group | Role | What they receive |
|---|---|---|
| Xenon | Experimental | 60%(1MAC)in oxygen (FiO2 = 0.35-0.45) Receives: Drug: Xenon |
| Sevoflurane | Active comparator | 1.1-1.4% (1 MAC) in oxygen (FiO2 = 0.35-0.45) and medical air Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Operative Delirium diagnosed with the Confusion Assessment Method within four days post-surgery
Measured: Four days
Secondary outcomes (5)
Post Operative Delirium diagnosed with the Confusion Assessment Method from day 5 post surgery to discharge from hospital
Measured: About 7 days
Sequential Organ Failure Assessment from day 1 to day 4 post-surgery
Measured: four days
Recovery Parameters
Measured: fifteen minutes
economic parameters
Measured: up to thirty days
Safety Parameters
Serious Adverse Events, Adverse Events, laboratory parameters
Measured: Up to thirty days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Liquide Santé International
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- OptumInsight
- Responsible party
- Sponsor
- Investigators
- Mark COBURN, MD, Study chair, University Hospital Aachen - GermanyRobert SANDERS, MD, Study chair, Imperial College London - UKRolf ROSSAINT, MD, Study chair, University Hospital Aachen - Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01199276
- Sponsor's protocol ID
- ALMED-08-C2-020
- Acronym
- HIPELD
- Status last verified
- Jul 2015
- First submitted
- 9 Sep 2010
- Last updated
- 27 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 29397119Coburn 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.
PubMed 23016882
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01199276
- Acronym / sponsor ID
- HIPELD / ALMED-08-C2-020
- Conditions
- Delirium
- Keywords
- Delirium, Hip Fracture, Elderly
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Air Liquide Santé InternationalIndustry (pharma, biotech, devices)
- Collaborators
- OptumInsight
- Study start
- Sep 2010
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 10 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xenon | Experimental | Drug: Xenon60%(1MAC)in oxygen (FiO2 = 0.35-0.45) |
| Sevoflurane | Active comparator | Drug: Sevoflurane1.1-1.4% (1 MAC) in oxygen (FiO2 = 0.35-0.45) and medical air |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XenonAlso: LENOXeGroup A: xenon 60% (55%-65%)(1 MAC) in oxygen (FiO2 = 0.35-0.45) | Drug | Xenon |
| SevofluraneGroup B: sevoflurane 1.1-1.4%(1 MAC) in oxygen (FiO2 = 0.35-0.45) and Medical air | Drug | Sevoflurane |
Primary outcome
Post Operative Delirium diagnosed with the Confusion Assessment Method within four days post-surgery
Time frame: Four days
5 secondary outcomes
Post Operative Delirium diagnosed with the Confusion Assessment Method from day 5 post surgery to discharge from hospital
Time frame: About 7 days
Sequential Organ Failure Assessment from day 1 to day 4 post-surgery
Time frame: four days
Recovery Parameters
Time frame: fifteen minutes
economic parameters
Time frame: up to thirty days
Safety Parameters
Time frame: Up to thirty days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2015.
- Derived from this study: PubMed 29397119Coburn 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.
- Derived from this study: PubMed 23016882Coburn 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark COBURN, MD study chair
University Hospital Aachen - Germany
Robert SANDERS, MD study chair
Imperial College London - UK
Rolf ROSSAINT, MD study chair
University Hospital Aachen - Germany
13 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Xenon and Sevoflurane in people with Delirium, run by Air Liquide Santé International at 13 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France, Germany, Belgium, Italy, Spain and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post Operative Delirium diagnosed with the Confusion Assessment Method within four days post-surgery (time frame: Four days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01199276, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2015.