Volatile Anesthetics to Reduce Mortality in Cardiac Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Università Vita-Salute San Raffaele
Sponsor:
Information provided by (Responsible Party):
Giovanni Landoni, Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier:
NCT02105610
First received: April 2, 2014
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

There is initial evidence that the choice of anesthesia can influence survival in the specific setting of coronary artery bypass grafting surgery (CABG).

A recent international consensus conference included volatile agents among the few drugs/techniques/strategies that might reduce perioperative mortality in cardiac surgery and that should be further studied. Volatile anesthetics (desflurane, isoflurane and sevoflurane) have non-anesthetic pharmacological characteristics that confer cardiac protection when compared to Total IntraVenous Anesthesia (TIVA). Several randomized controlled studies were summarized in a meta-analysis that documented a reduction in perioperative cardiac troponin release and mortality in patients receiving volatile anesthetics when compared to patients receiving a TIVA. There are four published studies (Bignami et al. 2009) (De Hert et al. 2009) (Jackobsen et al. 2007) (Landoni et al. 2007) suggesting that these benefits can translate into a reduced mortality rate in patients receiving volatile agents. The level of evidence for these four studies is not high (one meta-regression, one underpowered randomized controlled study, one retrospective study and one meta-analysis of small randomized studies) and there is need for a large multicentre randomized controlled study to confirm these findings, as suggested by the international consensus conference on this topic published in 2011 (Landoni et al 2011).

The purpose is to provide a large multicentre controlled randomized trial to demonstrate that volatile anesthetics can reduce 1 year mortality from 3% to 2% in patients undergoing CABG (either with or without cardiopulmonary bypass).

The results of this study can support the use of volatile agents in all CABG procedures worldwide (more than 500.000 per year) with 2.500 lives saved per year (in the hypothesis that nowadays half the procedures are performed with a TIVA and that 1 year mortality can be reduced from 3% to 2% using volatile agents).


Condition Intervention Phase
Aortocoronary Bypass
Cardiac Surgery
Coronary Artery Bypass Grafting
Drug: desflurane, isoflurane, sevoflurane
Drug: total intravenous anesthetics
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Volatile Anesthetics to Reduce Mortality in Cardiac Surgery: A Multicentre Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by Università Vita-Salute San Raffaele:

Primary Outcome Measures:
  • mortality [ Time Frame: 1 year ]

Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: volatile anesthetics (desflurane, isoflurane, sevoflurane) Drug: desflurane, isoflurane, sevoflurane
Active Comparator: total intravenous anesthesia Drug: total intravenous anesthetics

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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)
  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: NCT02105610

Contacts
Contact: giovanni landoni, Prof landoni.giovanni@hsr.it

Locations
Italy
Ospedale San Raffaele di Milano, Italy Recruiting
Milano, Italy, 20132
Contact: giovanni landoni, prof       landoni.giovanni@hsr.it   
Sponsors and Collaborators
Università Vita-Salute San Raffaele
Investigators
Study Chair: alberto zangrillo, Prof Vita-Salute University of Milano
  More Information

Additional Information:
Publications:
Responsible Party: Giovanni Landoni, MD, Associate Professor, Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier: NCT02105610     History of Changes
Other Study ID Numbers: VOLATILE/38/OSR
Study First Received: April 2, 2014
Last Updated: April 15, 2014
Health Authority: Italy: Ministry of Health

Keywords provided by Università Vita-Salute San Raffaele:
volatile anesthetics
desflurane
isoflurane
sevoflurane
TIVA
cardiac surgery
mortality
anesthesia
intensive care

Additional relevant MeSH terms:
Anesthetics
Isoflurane
Desflurane
Sevoflurane
Anesthetics, Intravenous
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 August 18, 2014