Cardiovascular Safety of Xenon in General Anaesthesia, in Patient With Cardiovascular Risk in Non Cardiac Surgery (CARVASAXe)
This study has been completed.
Sponsor:
Air Liquide Santé International
Collaborators:
BIOMNIS Central laboratory
MONITORING FORCE GROUP CROs
Information provided by (Responsible Party):
Air Liquide Santé International
ClinicalTrials.gov Identifier:
NCT01120405
First received: May 4, 2010
Last updated: October 1, 2012
Last verified: October 2012
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Purpose
The Primary Objective is to show non inferiority in cardiac safety (i.e myocardial necrosis-MN- assessed by positive cardiac Troponin I -cTnI- ultrasensitive assay) of a Xenon based general anesthesia procedure in patients with elevated cardiac risk scheduled for atherosclerotic vascular surgery (i.e patient with Coronary Arteries Disease risk) when compared to sevoflurane based general anesthesia procedure, postoperatively up to 3 days.
| Condition | Intervention | Phase |
|---|---|---|
|
Elevated Cardiac Risk Coronary Arteries Disease Risk |
Drug: Xenon Drug: Sevoflurane |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Screening |
| Official Title: | Cardiovascular Safety of Xenon in General Anaesthesia, in Patient With Cardiovascular Risk in Non Cardiac Surgery: A Phase III Multicenter Randomized Controlled Study |
Resource links provided by NLM:
MedlinePlus related topics:
Coronary Artery Disease
Drug Information available for:
Sevoflurane
U.S. FDA Resources
Further study details as provided by Air Liquide Santé International:
Primary Outcome Measures:
- positive cardiac Troponin I (cTnI) ultra sensitive assay (above the 99th percentile), at any time during the 72 h post operatively [ Time Frame: postop up to 3 days ] [ Designated as safety issue: Yes ]
The primary efficacy criterion is a biological marker:Increase above the 99th percentile of highly sensitive cardiac Troponin I -cTnI- (threshold established by the producer- central laboratory) at any time during the 72 h post operatively.
Evaluations will be performed before surgery, in the morning of D1 and D3 following surgery and at any other time in case of suspicion of Myocardial necrosis (damage).
Increase above the 99th percentile of highly sensitive cardiac Troponin I (cTnI) will define Myocardial Necrosis.
Secondary Outcome Measures:
- Routine post operative cardiac safety [ Time Frame: Post operatively up to 3 days ] [ Designated as safety issue: Yes ]Routine (Local laboratory) dosage of standard cardiac Troponin I (cTnI) at D1 (24h) and D3 (72 h) post operatively, and also in case of any suspicion of Myocardial Infarction (MI), Routine post op cardiac safety monitoring from the D0 to D3(Blood pressure , 12-lead ECG recording, Chest pain , Heart rate ), 24h diuresis, Diagnosis of MI, Diagnosis of the composite endpoint including MI, Myocardial Necrosis (MN), cerebrovascular events, life threatening arrhythmia, and death from cardiac origin
| Enrollment: | 604 |
| Study Start Date: | May 2010 |
| Study Completion Date: | July 2012 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Xenon
0.8-1.1 minimum alveolar concentration (MAC) Xenon in 30 % oxygen (Group A)
|
Drug: Xenon
Xenon general anesthesia maintenance 0.8-1.1 minimum alveolar concentration (MAC) Xenon in 30 % oxygen
Other Name: LENOXe
|
|
Active Comparator: sevoflurane
0.8-1.1 MAC in 30 % oxygen (Group B)
|
Drug: Sevoflurane
0.8-1.1 MAC Sevoflurane in 30 % oxygen
|
Detailed Description:
The Primary endpoint is defined as an increase above the 99th percentile of highly sensitive cardiac Troponin I (cTnI) at any time during the 72 h post operatively. Time frame 3 days post-op;
Key secondary endpoint(s) are routine (Local laboratory) dosage of standard cardiac Troponin I (cTnI) at D1 (24h) and D3 (72 h) post operatively, and also in case of any suspicion of Myocardial Infarction , Routine cardiac safety monitoring.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age ≥ 18 years
- Scheduled for atherosclerotic vascular elective surgery with presumed fast-track,
Cardiac ischaemic risk supported by:
- History of myocardial infarction older than 1 month and/or
- Documented Stable angina (asymptomatic ± medical treatment) and/or
- History of coronary revascularisation, and/or
- Surgical Risk Index ("Lee" index) ≥ 3.
- Written informed consent
Exclusion Criteria:
- Unstable angina within the last 30 days,
- Non controlled arterial Hypertension .
- Severe Cardiac heart Failure (NYHA IV)
- Severe Chronic Obstructive Pulmonary Disease
- Patient already randomized in another ongoing clinical trial
- Patient with recent myocardial infarction (M.I) (less than one month )
- Patient already included in a clinical trial
- History of hypersensitivity to study drugs( i.e Xenon, propofol, sevoflurane, desflurane, isoflurane)
- Malignant hyperthermia
- Documented Elevated intracranial pressure
- Preeclampsia or eclampsia
- Pregnancy and lactation
- Presumed uncooperativeness or legal incapacity
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01120405
Locations
| France | |
| Nouvel Hopital Civil | |
| Strasbourg, Bas Rhin, France, 67091 | |
| CHU Nord | |
| Marseille, Bouches du Rhône, France, 13915 | |
| Centre Hospitalier Universitaire de Caen - Pôle Anesthésie-Réanimation-SAMU, Avenue de la Côte de Nacre | |
| Caen, Calvados, France, 14033 Cedex 9 | |
| CHU Dijon | |
| Dijon, Côte d'Or, France, 21079 | |
| CHU Bordeaux Haut Lévèque | |
| Bordeaux, Gironde, France, 33604 | |
| Hopital Pellegrin | |
| Bordeaux, Gironde, France, 33076 | |
| CHU Rennes | |
| Rennes, Ille et Vilaine, France, 35009 | |
| CHRU, Hôpital Cardiologique, Département Anesthésie-Réanimation, Bld du Président Jules Leclerc | |
| Lille, Nord, France, 59037 Cedex | |
| CHU Clermont Ferrand | |
| Clermont Ferrand, Puy de Dôme, France, 63003 | |
| CHU Poitiers, Service Anesthésie-Réanimation, 2 rue de Milétrie, BP577 | |
| Poitiers, Vienne, France, 86021 Cedex | |
| Chu Pitie Salpetriere | |
| Paris, France, 75013 | |
| Hopital Saint Joseph | |
| Paris, France, 75014 | |
Sponsors and Collaborators
Air Liquide Santé International
BIOMNIS Central laboratory
MONITORING FORCE GROUP CROs
Investigators
| Principal Investigator: | Yanncik Le Manach, Assistant Prof | CHU PITIE SALPETRIERE, PARIS, FRANCE |
| Study Chair: | Pierre CORIAT, MD Prof | CHU PITIE SALPETRIERE, PARIS, FRANCE |
| Study Chair: | Benoit VALLET, MD Prof | CHU LILLE, France |
More Information
No publications provided
| Responsible Party: | Air Liquide Santé International |
| ClinicalTrials.gov Identifier: | NCT01120405 History of Changes |
| Other Study ID Numbers: | EudraCT #2010-018703-28 |
| Study First Received: | May 4, 2010 |
| Last Updated: | October 1, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Air Liquide Santé International:
|
Xenon Cardiac safety Cardiovascular risk Non cardiac surgery Atherosclerotic vascular surgery |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Anesthetics Xenon |
Sevoflurane Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anesthetics, Inhalation Anesthetics, General Platelet Aggregation Inhibitors Hematologic Agents |
ClinicalTrials.gov processed this record on May 16, 2013