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Sevoflurane in Cardiac Surgery (SEVO AIFA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00821262
Recruitment Status : Completed
First Posted : January 13, 2009
Last Update Posted : October 14, 2015
Sponsor:
Information provided by (Responsible Party):
Giovanni Landoni, Università Vita-Salute San Raffaele

Tracking Information
First Submitted Date  ICMJE January 12, 2009
First Posted Date  ICMJE January 13, 2009
Last Update Posted Date October 14, 2015
Study Start Date  ICMJE September 2008
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2012)
Composite endpoint or number of dead patients and/or number of patients requiring prolonged intensive care unit stay
Original Primary Outcome Measures  ICMJE
 (submitted: January 12, 2009)
Composite end point: death and/or prolonged intensive care unit stay
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2009)
  • cardiac troponin release
  • incidence of perioperative myocardial infarction
  • time on mechanical ventilation
  • postoperative hospital stay
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sevoflurane in Cardiac Surgery
Official Title  ICMJE Sevoflurane and Cardiac Protection in High Risk Patients Undergoing Cardiac Surgery. A Randomized Controlled Study.
Brief Summary

Patients undergoing high risk cardiac surgery (combined CABG and valvular procedures) will be randomized to receive a total intravenous anesthesia or an anesthesia plan with sevoflurane.

The investigators want to document whether the cardioprotective properties of volatile agents could translate in an improved outcome after cardiac surgery in high risk patients.

Detailed Description

Background

It is commonly believed that the choice of the primary anesthetic agent does not result in different outcomes after cardiac surgery. Recent evidence however has indicated that volatile anesthetics improve post-ischemic recovery. These results have been summarized in a meta-analysis of 22 randomized studies, involving 1922 patients: the use of volatile anesthetics was associated with significant reductions of myocardial infarctions (24/979 [2.4%] in the volatile anesthetics group vs 45/874 [5.1%] in the control arm, odds ratio [OR]=0.51 [0.32-0.84], and mortality (4/977 [0.4%] vs 14/872 [1.6%], OR=0.31 [0.12-0.80].

Furthermore, the use of volatile anesthetics was associated with shorter intensive-care unit stay (WMD=-7.10 hours [-11.47; -2.73], and time to hospital discharge (WMD=-2.26 days [-3.83; -0.68].

All the studies of the meta-analysis included low risk patients undergoing isolated procedures (mostly coronary artery bypass grafting).

Objectives

Investigators are planning a large multicentre randomized controlled study to confirm the beneficial cardioprotective effects of volatile anesthetics in cardiac surgery as indicated by a reduced intensive care stay and/or death in an high risk population of patients undergoing combined valvular and coronary procedures. Secondary endpoints will be: cardiac troponin release; incidence of myocardial infarction; time on mechanical ventilation; postoperative hospital stay

Methods

Various centers will randomize 200 patients to receive either a total intravenous anesthesia with propofol or an anesthesia with sevoflurane. All patients will receive a standard middle dose opiates anesthesia. All the perioperative management will be otherwise identical and standardized. Transfer out of the intensive care will be performed with SpO2 94% or greater at an FiO2 of 0.5 or less by facemask, adequate cardiac stability with no hemodynamically significant arrhythmias, chest tube drainage less than 50 ml/h, urine output greater than 0.5 ml/kg/h, no intravenous inotropic or vasopressor therapy in excess of dopamine 5 ug/kg/min, and no seizure activity.

Expected Results

The reduced cardiac damage (reduction in cardiac troponin release and in the incidence of myocardial infarction) will translate into a better tissue perfusion and faster recovery as documented by reduced intensive care unit.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Anesthesia
  • Cardiac Surgery
Intervention  ICMJE
  • Drug: sevoflurane
  • Drug: propofol
Study Arms  ICMJE
  • Experimental: sevoflurane
    The study group will receive Sevoflurane for a 4-6 hours period (from anesthesia induction to transfer to ICU).
    Intervention: Drug: sevoflurane
  • Active Comparator: propofol
    The control group will receive propofol for the same 4-6 hours period.
    Intervention: Drug: propofol
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 12, 2009)
200
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • age >18 years
  • written informed consent
  • scheduled procedures

Exclusion Criteria:

  • ongoing acute myocardial infarction
  • cardiac troponin >1 ng/ml
  • previous unusual response to an anesthetic
  • use of sulfonylurea, theophylline or allopurinol
  • thoracotomy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00821262
Other Study ID Numbers  ICMJE GO/URC/ER/mm 412/DG
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Giovanni Landoni, Università Vita-Salute San Raffaele
Study Sponsor  ICMJE Università Vita-Salute San Raffaele
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: giovanni landoni, MD Vita-Salute University of Milano. Italy
Study Director: elena bignami, MD Vita-Salute University of Milano, Italy
PRS Account Università Vita-Salute San Raffaele
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP