Contact information
Type
Scientific
Primary contact
Prof D Poldermans
ORCID ID
Contact details
Erasmus Medical Centre
Department of Anesthesiology
Rotterdam
3015 GD
Netherlands
+31 (0)10 463 4613
d.poldermans@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
DEDREASE VI
Study hypothesis
The primary objective of this trial is to validate the screening potential of N-Terminal pro-B-type Natriuretic Peptide (NT-proBNP) in a population of low to intermediate risk patients, i.e., patients with zero to two cardiac risk factors, scheduled for vascular surgery.
The secondary objective is to identify prior to vascular surgery high risk patients, with three or more cardiac risk factors, with a normal stress test.
Ethics approval
Approval received from the Medical Ethics Committee of the Erasmus Medical Centre on the 21st February 2007 (ref: CPB/ss/022897).
Study design
Prospective, non-randomised, non-controlled, parallel group, multicentre trial.
Primary study design
Interventional
Secondary study design
Multi-centre
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Condition
Non-cardiac surgery, perioperative cardiac complications
Intervention
Patients scheduled for major vascular surgery (i.e., aorta-iliac/femoral and femoro-popliteal/crural bypass operation) will be screened for the following cardiac risk factors:
1. Aged greater than 70 years
2. A history or symptoms of angina pectoris
3. A history of myocardial infarction (history and/or presence of Q-wave on Electrocardiogram [ECG])
4. A history of congestive heart failure
5. Diabetes mellitus
6. Renal dysfunction (serum creatinine greater than 180 µmol/l), or
7. A history of cerebrovascular accident.
The value of each cardiac risk factor is the same.
In all patients without the above risk factors, and those with one or two risk factors, NT-proBNP concentrations are measured. Those with a normal test are referred for surgery without additional testing.
Patients with an abnormal NT-proBNP concentration of greater than 350 pg/ml will be referred for non-invasive cardiac imaging. Imaging tests will assess Left Ventricular (LV) function at rest, the presence of a pressure gradient over the aortic valve, and the presence and extent of stress-induced ischaemia.
In all high-risk patients, those with three or more risk factors, NT-proBNP concentrations are measured. Routinely, all patients will be referred for additional testing for the evaluation of LV function at rest, the presence of a pressure gradient over the aortic valve, and the presence and extent of stress-induced ischaemia.
Myocardial ischaemia:
Patients without ischaemia as well as those with limited ischaemia are referred for surgery with beta-blocker therapy. In patients with extensive ischaemia, the treating physician will decide further perioperative care. This may be:
1. Cancellation of surgery, a limited procedure, or endovascular repair
2. Surgery with optimal medical cardio-protection, or
3. Prophylactic coronary revascularisation
The type of coronary revascularisation, bypass surgery or percutaneous coronary intervention, is decided by the treating physicians on the basis of coronary anatomy and the possible delay of the index surgical procedure.
Left ventricular failure:
Currently no specific guidelines exist on perioperative management in patients with heart failure. Heart failure has important long-term prognostic value and the decision to continue with surgery can rejected because of this unexpected finding. The attending physicians take this decision.
Aortic valve stenosis:
A mean gradient of 40 mmHg or more is associated with an increased perioperative cardiac event rate. The presence of aortic valve stenosis will influence perioperative anaesthesiological care and haemodynamic management. In selected cases preoperative valve replacement can be considered.
Beta-blocker therapy:
All patients are on perioperative beta-blocker therapy. In patients without beta-blockers, bisoprolol 2.5 mg once a day is started at the screening visit. Patients on chronic beta-blocker therapy continued their medication. Beta-blocker dose will be adjusted in all patients at admission to the hospital and on the day prior to surgery to achieve a resting heart frequency of 60 - 65 beats per minute. In case of symptoms or markers of myocardial ischaemia accompanied by tachycardia during surgery occurs, additional beta-blocker therapy is administrated. The same dose of beta-blockers will be continued postoperatively except in patients who were unable to take medication orally or by nasogastric tube postoperatively. In these patients, the heart rate is monitored continuously in the intensive care unit or hourly at the ward, and intravenous metoprolol is administered at a dose sufficient to keep the heart rate between 60 - 65 beats per minute. The heart rate and blood pressure are measured immediately before each scheduled dose of beta-blockers. Beta-blockers are withheld if the heart rate was under 50 beats per minute or the systolic blood pressure was under 100 mmHg.
Statin and anticoagulant therapy:
All patients are on perioperative statin therapy. Patients on chronic statin therapy continue their medication. Statin dose is not intensified prior to surgery for reduction of serum cholesterol levels. The same dose of statins will be continued as soon as possible after surgery, either by mouth or nasogastric tube. Statins are withheld if liver dysfunctions occur, defined as an Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) elevations of three-times the upper limit of normal.
Anticoagulant and antiplatelet after percutaneous coronary intervention are continued during surgery.
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
The primary objective of this trial is to validate the screening potential of NT-proBNP in a population of low to intermediate risk patients, i.e. patients with zero to two cardiac risk factors, scheduled for vascular surgery.
Secondary outcome measures
The secondary objective is to identify prior to vascular surgery high risk patients, with three or more cardiac risk factors, with a normal stress test.
Overall trial start date
01/03/2007
Overall trial end date
01/05/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients with peripheral vascular atherosclerosis scheduled for vascular surgery involving either of the following are eligible to participate:
a. revascularisation utilising aortic or proximal lower extremity procedures, or
b. distal lower extremity vascular reconstruction
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
1800
Participant exclusion criteria
1. Emergency surgical procedures
2. Unability or unwillingness to provide written informed consent
3. Previous participation in this same trial
4. Concurrent participation in another clinical trial
5. Contraindication for cardiac stress testing
Recruitment start date
01/03/2007
Recruitment end date
01/05/2009
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus Medical Centre
Rotterdam
3015 GD
Netherlands
Sponsor information
Organisation
Erasmus Medical Centre (The Netherlands)
Sponsor details
Department of Anesthesiology
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Erasmus Medical Centre (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary