MOBOS: Measurement Of NT-proBNP to Predict Outcomes in Surgery

Sponsor

Julie Dawson (Other)

Overall Status

Unknown status

CT.gov ID

NCT04014647

Collaborator

(none)

200

Enrollment

Location

23.9

Anticipated Duration (Months)

8.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vascular Surgical Procedure

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Peri-operative Measurement of NT-proBNP to Predict Outcomes in Patients Undergoing Elective Vascular Surgery

Actual Study Start Date :

Sep 5, 2019

Anticipated Primary Completion Date :

Sep 1, 2021

Anticipated Study Completion Date :

Sep 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Event-free Patients who have had no negative events (as described in group 2)
Negative event Group 2 - patients with one or more of the following negative events post-operatively: Whether the patient has been prescribed inotropic support Wound infection by assessing use of antibiotics. Length of stay in hospital >1 week Reduced renal function assessed by having any AKI alert during hospital stay Cardiac event within 31 days following surgery Death within 31 days following surgery

Arm

Intervention/Treatment

Event-free

Patients who have had no negative events (as described in group 2)

Negative event

Group 2 - patients with one or more of the following negative events post-operatively: Whether the patient has been prescribed inotropic support Wound infection by assessing use of antibiotics. Length of stay in hospital >1 week Reduced renal function assessed by having any AKI alert during hospital stay Cardiac event within 31 days following surgery Death within 31 days following surgery

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:-

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