Clinical Trials Logo

Clinical Trial Summary

This is a single-centre, prospective study to determine the correlation and comparative thresholds between N-terminal pro-brain natriuretic peptide (NT ProBNP, Roche) and brain natriuretic peptide (BNP, Abbott) tests. The study population will include patients assessed in presurgical screening (PSS) or on the day of surgery (DOS) who are presenting for elective surgery requiring a minimum of one-night admission, and are a) >65 years old, b) RCRI ≥1 or c) >45 years old with significant cardiovascular disease (coronary artery disease, peripheral arterial disease, cerebral vascular disease, congestive heart failure, obstructive intracardiac disease such as severe aortic stenosis, severe mitral stenosis or severe hypertrophic obstructive cardiomyopathy). Informed consent will be obtained at PSS or on the DOS by study staff. High sensitivity troponin I measurements will be taken on postoperative day (POD) 0, 1 and 2, and the outcome of MINS (high sensitivity troponin > 30 ng/L) or vascular death will be determined by an assessor blinded to BNP/NT ProBNP results at postoperative day (POD) 30. Given a sample size of 431 patients and based upon previous local data that found approximately 500 patients qualifying for BNP testing in a six month period, the investigators predict data collection to be completed in approximately six months.


Clinical Trial Description

This is a single-centre, prospective study to determine the correlation and comparative thresholds between NT ProBNP (Roche) and BNP (Abbott) tests. This will involve simultaneous serum sampling for both BNP and NT ProBNP at pre-surgical screening (PSS) or on the day of surgery (DOS). Serum sampling of BNP in this patient population is standard of care in our institution, thus only the additional blood required for the NT ProBNP test requires additional consent. Informed consent will be obtained at PSS or on the DOS by study staff. High sensitivity troponin I (Abbott) measurements will be taken on postoperative day (POD) 0, 1 and 2, as per local standard of care and the outcome of MINS (myocardial injury after non-cardiac surgery as indicated by high sensitivity troponin > 30 ng/L) or vascular death will be determined by an assessor blinded to BNP/NT ProBNP results at postoperative day (POD) 30. The primary outcome is correlation of POC NT ProBNP with BNP levels and validation of appropriate thresholds. The secondary outcome is combined MINS and vascular death at POD 30. The study population will include patients assessed in PSS or on the DOS who are presenting for elective surgery requiring a minimum of one-night admission following and are a) >65 years old, b) revised cardiac risk index (RCRI) ≥1 or c) >45 years old with significant cardiovascular disease (coronary artery disease, peripheral arterial disease, cerebral vascular disease, congestive heart failure, obstructive intracardiac disease such as severe aortic stenosis, severe mitral stenosis or severe hypertrophic obstructive cardiomyopathy). The required sample size of 431 patients was calculated to adequately perform a power assessment of the primary outcome of correlating BNP and NT ProBNP thresholds. Historically, Presurgical Screening (PSS) at Kingston Health Sciences Centre (KHSC) collects BNP serum samples from approximately 500 patients at PSS in a six month time frame, as reported by a local, retrospective quality assurance study (McMullen/Cook). This sample size will not likely be sufficient to determine significance regarding the secondary outcome of MINS or vascular death by POD 30. Nonetheless, the trend observed may be informative in the context of correlating the risk prediction provided by BNP screening at our centre to that from larger studies. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05352698
Study type Observational
Source Queen's University
Contact
Status Completed
Phase
Start date May 1, 2022
Completion date August 31, 2023

See also
  Status Clinical Trial Phase
Not yet recruiting NCT06043895 - EpiFaith CV for Central Venous Catheterization N/A
Completed NCT03308071 - Hypnosis for Symptom Management in Elective Orthopedic Surgery N/A
Not yet recruiting NCT03814681 - Postopoperarive Outcomes After Colorectal Surgery in Europe (euroPOWER)
Completed NCT03012802 - Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol
Completed NCT04724122 - Perioperative Care in Ethiopia
Completed NCT04037787 - ERAS (Enhanced Recovery After Surgery) Protocol Implementation in Piedmont Region for Colorectal Cancer Surgery N/A
Recruiting NCT06101641 - Effect of Shellac Nail Polish Application on Pulse Oximetry Measurements in Healthy Individuals N/A
Not yet recruiting NCT03865810 - Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol in Gastric Surgery for Cancer
Not yet recruiting NCT03864861 - Postoperative Outcomes Within an Enhanced Recovery After Bariatric Surgery Protocol
Completed NCT00994903 - Simvastatin in Colorectal Surgery Phase 3
Completed NCT04540315 - Reducing Surgical Readmissions Through Mobile Technology N/A
Not yet recruiting NCT06436560 - Support for Transgender and Non-Binary Individuals Seeking Vaginoplasty Study N/A
Completed NCT00911391 - Randomised Trial of Doppler-Optimised Fluid Balance in Elective Colectomy Phase 3
Completed NCT03325413 - Improvement of Perioperative Care of Elderly Patients N/A
Completed NCT04770259 - Pre-surgical Protocol for Frail Elderly People in Order to Reduce Hospitalization Days (APOPM). N/A
Completed NCT02580214 - Immunonutrition in Total Hip Arthroplasty Phase 2/Phase 3
Completed NCT01053169 - Observational Study of Prophylaxis and Treatment of Acute Perioperative Bleeding With Beriplex® P/N (Probe Study) N/A
Completed NCT01399814 - Restricted Intravenous Fluid Regime Effects on Immunological Indicators of Elderly Patients Operated for Abdominal Cancer Phase 3
Completed NCT00464529 - Accuracy and Safety of Real Time Continuous Glucose Monitoring Before, During and After Surgery N/A
Completed NCT03111875 - Perioperative Hypothermia and Myocardial Injury After Non-cardiac Surgery N/A