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

Sponsors and Collaborators:	University Hospital, Basel, Switzerland Abbott
Information provided by:	University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:	NCT00286585

Purpose

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.

Condition	Intervention	Phase
Coronary Atherosclerosis	Drug: sevoflurane Drug: propofol	Phase IV

MedlinePlus related topics: Anesthesia Surgery

Drug Information available for: Sevoflurane Propofol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety Study
Official Title:	Multi-Center Trial on the Effect of Anesthetics on Morbidity and Mortality in Patients Undergoing Major Non-Cardiac Surgery

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:

Ischemia (Holter-electrocardiogram [ECG], troponin T, ECG) [ Time Frame: 7 days postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Congestive heart failure (N-terminal B-type natriuretic peptide [NT-pro-BNP]) [ Time Frame: 2 days postoperatively ] [ Designated as safety issue: No ]
influence of genetic polymorphism on cardiac morbidity and mortality [ Time Frame: 7 days, 6 and 12 months ] [ Designated as safety issue: No ]
cardiac morbidity and mortality [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	408
Study Start Date:	February 2006
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
I: Active Comparator Sevoflurane group	Drug: sevoflurane dosage according to the physician in charge
II: Active Comparator Propofol group	Drug: propofol dosage according to the physician in charge

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.

Eligibility

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00286585

Contacts

Contact: Daniel Bolliger, Dr. med.	+41 61 265 2525	dabolliger@uhbs.ch
Contact: Manfred D Seeberger, Prof. Dr.	+41 61 265 2525	mseeberger@uhbs.ch

Locations

Switzerland
University Hospital	Recruiting
Basel, Switzerland, CH-4000
Contact: Daniel Bolliger, Dr. +41 61 265 2525 dabolliger@uhbs.ch
Contact: Manfred D Seeberger, Prof. Dr. +41 61 265 2525 mseeberger@uhbs.ch
Principal Investigator: Daniel Bolliger, Dr.
Bürgerspital	Not yet recruiting
Solothurn, Switzerland, CH-4500
Contact: Philipp Schumacher, Dr. +41 32 627 3121
Principal Investigator: Philipp Schumacher, Dr.
Switzerland, Basel-Land
Kantonsspital	Not yet recruiting
Liestal, Basel-Land, Switzerland, CH-4410
Contact: Wolfgang Studer, Dr. +41 61 925 2525
Principal Investigator: Wolfgang Studer, Dr.

Sponsors and Collaborators

University Hospital, Basel, Switzerland

Abbott

Investigators

Principal Investigator:	Daniel Bolliger, Dr. med.	Department of Anesthesia, University Hospital, Basel, Switzerland
Principal Investigator:	Miodrag Filipovic, PD Dr.	Department of Anesthesia, University Hospital, Basel, Switzerland

More Information

No publications provided

Responsible Party:	- ( Prof. Dr. M. Seeberger, Head of Cardiothoracic Anesthesia )
Study ID Numbers:	261/05, IIS-SWIT-05-002
Study First Received:	February 2, 2006
Last Updated:	March 12, 2009
ClinicalTrials.gov Identifier:	NCT00286585 History of Changes
Health Authority:	Switzerland: Swissmedic

Keywords provided by University Hospital, Basel, Switzerland:

preconditioning
cardiac protection
morbidity
mortality

major non-cardiac surgery
cardiac mortality and morbidity
high cardiac perioperative risk

Study placed in the following topic categories:

Atherosclerosis
Arterial Occlusive Diseases
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Anesthetics
Central Nervous System Depressants
Arteriosclerosis

Ischemia
Sevoflurane
Coronary Disease
Anesthetics, Inhalation
Anesthetics, General
Platelet Aggregation Inhibitors
Propofol
Coronary Artery Disease

Additional relevant MeSH terms:

Atherosclerosis
Arterial Occlusive Diseases
Heart Diseases
Myocardial Ischemia
Hematologic Agents
Physiological Effects of Drugs
Vascular Diseases
Anesthetics
Central Nervous System Depressants
Arteriosclerosis

Pharmacologic Actions
Sevoflurane
Coronary Disease
Anesthetics, Inhalation
Anesthetics, General
Therapeutic Uses
Platelet Aggregation Inhibitors
Cardiovascular Diseases
Central Nervous System Agents
Coronary Artery Disease

ClinicalTrials.gov processed this record on May 07, 2009