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

Primary Purpose

Elevated Cardiac Risk, Coronary Arteries Disease Risk

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Xenon
Sevoflurane
Sponsored by
Air Liquide Santé International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Elevated Cardiac Risk focused on measuring Xenon, Cardiac safety, Cardiovascular risk, Non cardiac surgery, Atherosclerotic vascular surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nouvel Hopital Civil
  • CHU Nord
  • Centre Hospitalier Universitaire de Caen - Pôle Anesthésie-Réanimation-SAMU, Avenue de la Côte de Nacre
  • CHU Dijon
  • Hopital Pellegrin
  • CHU Bordeaux Haut Lévèque
  • CHU Rennes
  • CHRU, Hôpital Cardiologique, Département Anesthésie-Réanimation, Bld du Président Jules Leclerc
  • CHU Clermont Ferrand
  • Hopital Henri Mondor
  • CHU Poitiers, Service Anesthésie-Réanimation, 2 rue de Milétrie, BP577
  • Chu Pitie Salpetriere
  • Hopital Saint Joseph

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Xenon

sevoflurane

Arm Description

0.8-1.1 minimum alveolar concentration (MAC) Xenon in 30 % oxygen (Group A)

0.8-1.1 Minimum Alveolar Concentration (MAC) Sevoflurane in 30 % oxygen (Group B)

Outcomes

Primary Outcome Measures

Number of Participants With Myocardial Necrosis (MN)
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)
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)
Patients with Confirmed Myocardial Infarction (MI) by the Investigators
Number of Participants With Cerebro-Vascular Event
Patients with Cerebro-Vascular Event in the FAS
Number of Participants With Life-Threatening Arrhythmia
Patients with Life-Threatening Arrhythmia in the FAS
Number of Participants Who Died From Cardiac Origin
No patient died from a cardiac cause during the 3 postoperative days.
Number of Participants With Composite Endpoint
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)
Repeated Systolic Blood Pressure measurements during the perioperative period
Vital Signs (SBP and DBP Changes)
Changes from baseline for Systolic and Diastolic Blood Pressure (SBP and DBP)
Vital Signs (Heart Rate Changes)
Changes from baseline for Heart Rate (HR)
Number of Participants With Chest Pain During the 3 Postoperative Days
Patients with Chest Pain reported at least once per day during the 3 Postoperative Days
Urine Output
Urine volume in milliliter (mL) during the first postoperative hours

Full Information

First Posted
May 4, 2010
Last Updated
May 20, 2014
Sponsor
Air Liquide Santé International
Collaborators
Eurofins Biomnis, Monitoring Force Group, Inferential
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1. Study Identification

Unique Protocol Identification Number
NCT01120405
Brief Title
Cardiovascular Safety of Xenon in General Anaesthesia, in Patient With Cardiovascular Risk in Non Cardiac Surgery
Acronym
CARVASAXe
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Air Liquide Santé International
Collaborators
Eurofins Biomnis, Monitoring Force Group, Inferential

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elevated Cardiac Risk, Coronary Arteries Disease Risk
Keywords
Xenon, Cardiac safety, Cardiovascular risk, Non cardiac surgery, Atherosclerotic vascular surgery

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Xenon
Arm Type
Experimental
Arm Description
0.8-1.1 minimum alveolar concentration (MAC) Xenon in 30 % oxygen (Group A)
Arm Title
sevoflurane
Arm Type
Active Comparator
Arm Description
0.8-1.1 Minimum Alveolar Concentration (MAC) Sevoflurane in 30 % oxygen (Group B)
Intervention Type
Drug
Intervention Name(s)
Xenon
Other Intervention Name(s)
LENOXe
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Other Intervention Name(s)
Sevo
Primary Outcome Measure Information:
Title
Number of Participants With Myocardial Necrosis (MN)
Description
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)
Time Frame
3 Postoperative Days
Secondary Outcome Measure Information:
Title
Number of Participants With Cardiac Troponin I or T Above the 99th Percentile (Local Laboratories)
Description
At least 1 value of serum cardiac troponin I or T above the 99th percentile (measurements performed by local laboratories using different techniques)
Time Frame
3 Postoperative days
Title
Number of Participants With Myocardial Infarction (MI)
Description
Patients with Confirmed Myocardial Infarction (MI) by the Investigators
Time Frame
3 Postoperative Days
Title
Number of Participants With Cerebro-Vascular Event
Description
Patients with Cerebro-Vascular Event in the FAS
Time Frame
3 postoperative days
Title
Number of Participants With Life-Threatening Arrhythmia
Description
Patients with Life-Threatening Arrhythmia in the FAS
Time Frame
3 Postoperative Days
Title
Number of Participants Who Died From Cardiac Origin
Description
No patient died from a cardiac cause during the 3 postoperative days.
Time Frame
3 postoperative days
Title
Number of Participants With Composite Endpoint
Description
Patients with at least 1 event among MN assessed by central laboratory, MI, Cerebro-Vascular event, Life-Threatening Arrhythmia and Death from Cardiac Origin
Time Frame
3 postoperative days
Title
Systolic Blood Pressure (SBP)
Description
Repeated Systolic Blood Pressure measurements during the perioperative period
Time Frame
From pre-induction to recovery of anesthesia
Title
Vital Signs (SBP and DBP Changes)
Description
Changes from baseline for Systolic and Diastolic Blood Pressure (SBP and DBP)
Time Frame
From pre-induction to Postoperative Day 3
Title
Vital Signs (Heart Rate Changes)
Description
Changes from baseline for Heart Rate (HR)
Time Frame
From pre-induction to Postoperative Day 3
Title
Number of Participants With Chest Pain During the 3 Postoperative Days
Description
Patients with Chest Pain reported at least once per day during the 3 Postoperative Days
Time Frame
From Day 0 until Postoperative Day 3
Title
Urine Output
Description
Urine volume in milliliter (mL) during the first postoperative hours
Time Frame
From Day 0 until Postoperative Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanncik Le Manach, MD
Organizational Affiliation
CHU PITIE SALPETRIERE, PARIS, FRANCE
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pierre CORIAT, MD Prof
Organizational Affiliation
CHU PITIE SALPETRIERE, PARIS, FRANCE
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Benoit VALLET, MD Prof
Organizational Affiliation
University Hospital, Lille
Official's Role
Study Chair
Facility Information:
Facility Name
Nouvel Hopital Civil
City
Strasbourg
State/Province
Bas Rhin
ZIP/Postal Code
67091
Country
France
Facility Name
CHU Nord
City
Marseille
State/Province
Bouches du Rhône
ZIP/Postal Code
13915
Country
France
Facility Name
Centre Hospitalier Universitaire de Caen - Pôle Anesthésie-Réanimation-SAMU, Avenue de la Côte de Nacre
City
Caen
State/Province
Calvados
ZIP/Postal Code
14033 Cedex 9
Country
France
Facility Name
CHU Dijon
City
Dijon
State/Province
Côte d'Or
ZIP/Postal Code
21079
Country
France
Facility Name
Hopital Pellegrin
City
Bordeaux
State/Province
Gironde
ZIP/Postal Code
33076
Country
France
Facility Name
CHU Bordeaux Haut Lévèque
City
Bordeaux
State/Province
Gironde
ZIP/Postal Code
33604
Country
France
Facility Name
CHU Rennes
City
Rennes
State/Province
Ille et Vilaine
ZIP/Postal Code
35009
Country
France
Facility Name
CHRU, Hôpital Cardiologique, Département Anesthésie-Réanimation, Bld du Président Jules Leclerc
City
Lille
State/Province
Nord
ZIP/Postal Code
59037 Cedex
Country
France
Facility Name
CHU Clermont Ferrand
City
Clermont Ferrand
State/Province
Puy de Dôme
ZIP/Postal Code
63003
Country
France
Facility Name
Hopital Henri Mondor
City
Creteil
State/Province
Val de Marne
ZIP/Postal Code
94000
Country
France
Facility Name
CHU Poitiers, Service Anesthésie-Réanimation, 2 rue de Milétrie, BP577
City
Poitiers
State/Province
Vienne
ZIP/Postal Code
86021 Cedex
Country
France
Facility Name
Chu Pitie Salpetriere
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Hopital Saint Joseph
City
Paris
ZIP/Postal Code
75014
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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