Measurement Of NT-proBNP to Predict Outcomes in Surgery
- Conditions
- Vascular Surgical Procedure
- Registration Number
- NCT04014647
- Lead Sponsor
- Julie Dawson
- Brief Summary
The team is investigating whether N-terminal pro B-type natriuretic peptide (NT-proBNP) and other cardiac markers are useful for predicting outcomes for patients undergoing vascular surgery. By measuring NT-proBNP before and after surgery, the investigators may be able to determine which patients are at risk of an adverse outcome, such as a heart attack or death.
- Detailed Description
Almost 1 in 5 patients who have elective major vascular surgery experience death or a myocardial infarction (MI) at 18 months post-surgery. Research has shown that peri-operative interventions may improve outcomes for high-risk patients. Cardiac bio-markers may be used to identify these high-risk patients, in particular pre- and post-operative NT-proBNP.
Mahla found that by comparing surgery outcomes with NT-proBNP concentrations peri-operatively, high-risk patients could be identified and subsequent therapeutic decisions could be made to minimise adverse outcomes.
Van Kimmenade evaluated patients with acute heart failure and found that galectin-3 (Gal-3) was the best predictor of 60-day mortality compared with NT-proBNP and apelin (another cardiac marker), whereas NT-proBNP was the most useful for diagnosing HF. The authors also found that the combination of both markers (Gal-3 and NT-proBNP) have an even higher predictive value for outcome.
The predictive role of troponin I (cTnI) has been observed in a paper by Bursi et al. (2005) where patients undergoing elective major vascular surgery were stratified using the American College of Cardiology/American Heart Association (ACC/AHA) guidelines and followed up over a period of 24 months. Patients in every group with an elevated post-operative cTnI (≥100ng/L) were at greater risk of either MI or death.
The successful identification of high-risk patients can go on to have interventional risk-reducing pharmacological, therapeutic, diagnostic, or observational measures.
Prevention of cardiovascular events, particular for an aging population, can have positive impact on both the patient and society as a whole as it may result in patients maintaining their independence, avoiding major illness, avoiding nursing home care and living longer.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 200
- Patients who are equal to or over 18 years old
- Patients scheduled to undergo elective surgery for the following procedures:
- Infrainguinal arterial reconstruction
- Aortic aneurysm
- Aorto-bifemoral bypass / or aortic endarterectomy
- Femoro-popliteal bypass
- Femoro-distal bypass
- Femoral endarterectomy
- Femoro-femoral crossover
- Axillo-femoral bypass
- Elective carotid surgery
- Patients having either general or regional anaesthesia for their surgery
- Patients undergoing emergency surgery
- Those who are unable or unwilling to give informed consent
- Patients with unstable coronary syndromes (acute or recent MI with evidence of important ischemic risk by clinical symptoms or stress testing or unstable or severe angina pectoris)
- Patients with decompensated heart failure (new onset shortness of breath and rales together with echocardiographic evidence of cardiac dysfunction or deterioration of chronic heart failure despite heart failure therapy)
- Patients with chronic atrial fibrillation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method NT-proBNP blood test measured on the day of (pre-) vascular surgery 4 days NT-proBNP blood test measured on the day of (pre-) vascular surgery
NT-proBNP blood test measured on the day 4 after (post-) vascular surgery 4 days NT-proBNP blood test measured on the day 4 after (post-) vascular surgery
Change in NT-proBNP peri-operatively 4 days Change in NT-proBNP peri-operatively
- Secondary Outcome Measures
Name Time Method Pre-, post-, and peri-operative troponin I 4 days Pre-, post-, and peri-operative troponin I
Pre-, post-, and peri-operative galectin-3 4 days Pre-, post-, and peri-operative galectin-3
Pre-, post-, and peri-operative CRP 4 days Pre-, post-, and peri-operative CRP
Pre-, post-, and peri-operative creatinine 4 days Pre-, post-, and peri-operative creatinine
Trial Locations
- Locations (1)
Norfolk & Norwich University Hospitals NHS Foundation Trust
🇬🇧Norwich, Norfolk, United Kingdom