Cardiovascular Safety of Xenon in General Anaesthesia, in Patient With Cardiovascular Risk in Non Cardiac Surgery (CARVASAXe)

This study has been completed.
Sponsor:
Collaborators:
BIOMNIS Central laboratory
MONITORING FORCE GROUP CROs
INFERENTIAL
Information provided by (Responsible Party):
Air Liquide Santé International
ClinicalTrials.gov Identifier:
NCT01120405
First received: May 4, 2010
Last updated: May 20, 2014
Last verified: May 2014
  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:


Further study details as provided by Air Liquide Santé International:

Primary Outcome Measures:
  • Number of Participants With Myocardial Necrosis (MN) [ Time Frame: 3 Postoperative Days ] [ Designated as safety issue: No ]
    Myocardial Necrosis: at least 1 value of serum cardiac troponin I above the 99th percentile (measurement performed by a central laboratory using the ABBOTT-ARCHITECT technique)


Secondary Outcome Measures:
  • Number of Participants With Cardiac Troponin I or T Above the 99th Percentile (Local Laboratories) [ Time Frame: 3 Postoperative days ] [ Designated as safety issue: No ]
    At least 1 value of serum cardiac troponin I or T above the 99th percentile (measurements performed by local laboratories using different techniques)

  • Number of Participants With Myocardial Infarction (MI) [ Time Frame: 3 Postoperative Days ] [ Designated as safety issue: No ]
    Patients with Confirmed Myocardial Infarction (MI) by the Investigators

  • Number of Participants With Cerebro-Vascular Event [ Time Frame: 3 postoperative days ] [ Designated as safety issue: No ]
    Patients with Cerebro-Vascular Event in the FAS

  • Number of Participants With Life-Threatening Arrhythmia [ Time Frame: 3 Postoperative Days ] [ Designated as safety issue: No ]
    Patients with Life-Threatening Arrhythmia in the FAS

  • Number of Participants Who Died From Cardiac Origin [ Time Frame: 3 postoperative days ] [ Designated as safety issue: No ]
    No patient died from a cardiac cause during the 3 postoperative days.

  • Number of Participants With Composite Endpoint [ Time Frame: 3 postoperative days ] [ Designated as safety issue: No ]
    Patients with at least 1 event among MN assessed by central laboratory, MI, Cerebro-Vascular event, Life-Threatening Arrhythmia and Death from Cardiac Origin

  • Systolic Blood Pressure (SBP) [ Time Frame: From pre-induction to recovery of anesthesia ] [ Designated as safety issue: No ]
    Repeated Systolic Blood Pressure measurements during the perioperative period

  • Vital Signs (SBP and DBP Changes) [ Time Frame: From pre-induction to Postoperative Day 3 ] [ Designated as safety issue: Yes ]
    Changes from baseline for Systolic and Diastolic Blood Pressure (SBP and DBP)

  • Vital Signs (Heart Rate Changes) [ Time Frame: From pre-induction to Postoperative Day 3 ] [ Designated as safety issue: Yes ]
    Changes from baseline for Heart Rate (HR)

  • Number of Participants With Chest Pain During the 3 Postoperative Days [ Time Frame: From Day 0 until Postoperative Day 3 ] [ Designated as safety issue: Yes ]
    Patients with Chest Pain reported at least once per day during the 3 Postoperative Days

  • Urine Output [ Time Frame: From Day 0 until Postoperative Day 1 ] [ Designated as safety issue: Yes ]
    Urine volume in milliliter (mL) during the first postoperative hours


Enrollment: 600
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
Other Name: LENOXe
Active Comparator: sevoflurane
0.8-1.1 Minimum Alveolar Concentration (MAC) Sevoflurane in 30 % oxygen (Group B)
Drug: Sevoflurane
Other Name: Sevo

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Hopital Henri Mondor
Creteil, Val de Marne, France, 94000
CHU Poitiers, Service Anesthésie-Réanimation, 2 rue de Milétrie, BP577
Poitiers, Vienne, France, 86021 Cedex
Hopital Saint Joseph
Paris, France, 75014
Chu Pitie Salpetriere
Paris, France, 75013
Sponsors and Collaborators
Air Liquide Santé International
BIOMNIS Central laboratory
MONITORING FORCE GROUP CROs
INFERENTIAL
Investigators
Principal Investigator: Yanncik Le Manach, MD 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
Results First Received: March 20, 2014
Last Updated: May 20, 2014
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
Sevoflurane
Xenon
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 01, 2014