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TEAM-Project: Trial on the Effect of Anesthetics on Morbidity and Mortality

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ClinicalTrials.gov Identifier: NCT00286585
Recruitment Status : Completed
First Posted : February 3, 2006
Last Update Posted : August 27, 2012
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Tracking Information
First Submitted Date  ICMJE February 2, 2006
First Posted Date  ICMJE February 3, 2006
Last Update Posted Date August 27, 2012
Study Start Date  ICMJE February 2006
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 26, 2008)
Ischemia (Holter-electrocardiogram [ECG], troponin T, ECG) [ Time Frame: 7 days postoperatively ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 2, 2006)
  • Ischemia (Holter-ECG, troponin T)
  • cardiac morbidity and mortality after 6 and 12 months
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2008)
  • Congestive heart failure (N-terminal B-type natriuretic peptide [NT-pro-BNP]) [ Time Frame: 2 days postoperatively ]
  • influence of genetic polymorphism on cardiac morbidity and mortality [ Time Frame: 7 days, 6 and 12 months ]
  • cardiac morbidity and mortality [ Time Frame: 6 and 12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2006)
  • congestive heart failure (NT-pro-BNP)
  • influence of genetic polymorphism on cardiac morbidity and mortality
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TEAM-Project: Trial on the Effect of Anesthetics on Morbidity and Mortality
Official Title  ICMJE Multi-Center Trial on the Effect of Anesthetics on Morbidity and Mortality in Patients Undergoing Major Non-cardiac Surgery
Brief Summary

Volatile anesthetics may provide some protection from myocardial ischemia, an effect called anesthetic preconditioning. In patients undergoing coronary artery bypass surgery, this preconditioning effect resulted in better cardiac performance, faster recovery and lower morbidity and mortality.

The investigators will perform a prospective randomized multi-center study to compare volatile with total intravenous anesthesia in patients at a high cardiac risk who undergo major non-cardiac surgery.

Detailed Description Basic research and animal studies have detected that volatile anesthetics provide some protection from myocardial ischemia, an effect called anesthetic preconditioning. Recent clinical studies have found that this preconditioning effect is of clinical relevance in patients undergoing coronary artery bypass surgery, resulting in better cardiac function and faster recovery after surgery, and in lower one-year morbidity. In patients undergoing non cardiac surgery, cardiac complications also are the major cause of perioperative morbidity and mortality. Myocardial ischemia frequently occurs during and immediately after non cardiac surgery in patients with coronary artery disease, and is a strong predictor of subsequent cardiac complications and death. Whether or not volatile anesthetics also provide clinically relevant protection from perioperative ischemia and subsequent cardiac complications in patients undergoing non cardiac surgery is unknown. Therefore, we will perform a prospective, randomized multi-center study to compare volatile with total intravenous anesthesia in patients at high cardiac risk who undergo major non cardiac surgery. We hypothesize that the use of a volatile anesthetic will reduce the incidence of perioperative ischaemia and myocardial injury, as indicated primarily by less ST-segment changes in the Holter ECG and, if there will be an effect, secondarily by lower incidences of elevated troponin T and NT-pro-BNP levels. And we hypothesize that the use of a volatile anesthetic will reduce the one-year incidence of cardiac complications and all cause mortality after surgery. The results of this study may apply to a huge percentage of surgical patients because coronary artery disease is the clinically most relevant co-morbidity, and its prevalence is expected to increase with the steadily increasing number of surgical patients aged 65 yr and older.
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 Coronary Artery Disease
Intervention  ICMJE
  • Drug: Inhalational anesthetic
    Sevoflurane, dosage according to the physician in charge
    Other Names:
    • Ultane,
    • Sevorane
  • Drug: Intravenous anesthetic, propofol
    Propofol, dosage according to the physician in charge
    Other Names:
    • Diprivan,
    • Diprovan
Study Arms  ICMJE
  • Active Comparator: Inhalational anesthetic
    Sevoflurane will be used as the main anesthetic in this arm, and no propofol will be administered
    Intervention: Drug: Inhalational anesthetic
  • Active Comparator: Intravenous anesthetic, propofol
    Propofol will be used as the main anesthetic in this arm, and no inhalational anesthetic will be administered
    Intervention: Drug: Intravenous anesthetic, 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: August 24, 2012)
385
Original Enrollment  ICMJE
 (submitted: February 2, 2006)
408
Actual Study Completion Date  ICMJE November 2011
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients scheduled for a non-cardiac surgical procedure of high or intermediate cardiac risk are eligible if they have documented coronary artery disease (CAD) or are at high risk of CAD.

Exclusion Criteria:

  • Ongoing medication with sulfonylurea derivatives (unless stopped ≥ 2 days before surgery) or theophylline
  • Emergency surgery
  • Unstable angina pectoris
  • Preoperative hemodynamic instability
  • Severe hepatic disease
  • Renal insufficiency (creatinine clearance < 30 ml/min)
  • Severe chronic obstructive pulmonary disease (forced expiratory volume in 1 second [FEV1] < 1 litre)
  • Absence of written patient consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00286585
Other Study ID Numbers  ICMJE 261/05
IIS-SWIT-05-002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Basel, Switzerland
Study Sponsor  ICMJE University Hospital, Basel, Switzerland
Collaborators  ICMJE Abbott
Investigators  ICMJE
Principal Investigator: Manfred Seeberger, Prof. Dr. Department of Anesthesia, University Hospital, Basel, Switzerland
PRS Account University Hospital, Basel, Switzerland
Verification Date August 2012

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