Volatile anesthetics to reduce mortality in cardiac surgery. A multicentre randomized controlled study.

• Register: EUCTR
• Last refreshed on: 8 August 2016
• Main ID: EUCTR2013-005533-20-BE
• Date of registration: 22/01/2016
• Prospective Registration: Yes
• Primary sponsor: Ghent University Hospital
• Public title: Volatile anesthetics to reduce mortality in cardiac surgery. A multicentre randomized controlled study.
• Scientific title: Volatile anesthetics to reduce mortality in cardiac surgery. A multicentre randomized controlled study. - Volatile anesthetics to reduce mortality in cardiac surgery.
• Date of first enrolment: 18/02/2016
• Target sample size: 5200
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-005533-20
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Bahrain, Belarus, Belgium, Brazil, China, Colombia, Egypt, Georgia, Iran, Islamic Republic of, Malaysia, New Zealand, Pakistan, Russian Federation, Saudi Arabia, South Africa, Switzerland, Thailand, Turkey

Contacts

• Name: Bimetra Clinics
• Affiliation: Ghent University Hospital

• Name: Bimetra Clinics
• Affiliation: Ghent University Hospital

Key inclusion & exclusion criteria

Inclusion criteria:
-age >18 years
-written informed consent
-scheduled procedures
-planned isolated CABG (multiple bypass are allowed; planned combined intervention such as CABG plus valve surgery are not allowed)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10600
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
-pregnancy
-planned valve surgery or surgery on the aorta
-planned locoregional anesthesia without general anesthesia
-unstable or ongoing angina
-recent (< 1 month) or ongoing acute myocardial infarction
-use of sulfonylurea, theophylline or allopurinol
-previous unusual response to an anesthetic agent
-inclusion in other randomised controlled studies in the previous 30 days
-any general anesthesia performed in the previous 30 days
-emergency operation (not scheduled)
-kidney or liver transplant in medical history
-liver cirrhosis (Child B or C)
-patients with absolute contraindications to anesthetic agents as per summary of product characteristics


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Coronary artery bypass grafting surgery (CABG).

Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Intervention(s)

Trade Name: SEVORANE 100%, vloeistof voor inhalatiedamp
Pharmaceutical Form: Inhalation solution
INN or Proposed INN: SEVOFLURANE
CAS Number: 28523-86-6
Other descriptive name: SEVOFLURANE
Concentration unit: % percent
Concentration type: equal
Concentration number: 100-

Trade Name: Diprivan 2%, emulsie voor infusie
Pharmaceutical Form:
INN or Proposed INN: PROPOFOL
Other descriptive name: PROPOFOL
Concentration unit: % percent
Concentration type: equal
Concentration number: 2-

Primary Outcome(s)

Secondary Objective: Not applicable

Primary end point(s): The primary end point of the study will be 1 year mortality (any cause).

Main Objective: To compare mortality and adverse effects rates after randomisation between inhalation anaesthesia and/or intravenous anaesthesia.

Timepoint(s) of evaluation of this end point: 1 year after anaesthesia.

Secondary Outcome(s)

Secondary end point(s): - 30 days mortality (any cause).
-30 days death or non-fatal myocardial infarction (composite endpoint)
-cardiac mortality at 30 days and at 1 year
-hospital readmission during the 1 year follow up period
-ICU and hospital stay.

Timepoint(s) of evaluation of this end point: 30 days and 1 year after anaesthesia.

Secondary ID(s)

AGO/2016/001

Source(s) of Monetary Support

San Raffaele Hospital

Ghent University Hospital

Secondary Sponsor(s)

San Raffaele Hospital