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

Phase 1

• Conditions: Coronary artery bypass grafting surgery (CABG).; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2013-005533-20-BE
• Lead Sponsor: Ghent University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-22
• Last Update Posted: 8 August 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 5200

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare mortality and adverse effects rates after randomisation between inhalation anaesthesia and/or intravenous anaesthesia.;Secondary Objective: Not applicable;Primary end point(s): The primary end point of the study will be 1 year mortality (any cause).;Timepoint(s) of evaluation of this end point: 1 year after anaesthesia.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - 30 days mortality (any cause).<br>-30 days death or non-fatal myocardial infarction (composite endpoint)<br>-cardiac mortality at 30 days and at 1 year<br>-hospital readmission during the 1 year follow up period<br>-ICU and hospital stay.;Timepoint(s) of evaluation of this end point: 30 days and 1 year after anaesthesia.