BNP Evaluation Before Surgery Study: an Observational Study of Natriuretic Peptide Levels Prior to Surgery.

Completed

• Conditions: Surgery, Cardiovascular

• Registration Number: NCT04114032
• Lead Sponsor: University of Cape Town

Brief Summary

A prospective, multi-centre, observational study of preoperative natriuretic peptide testing for patients undergoing non-cardiac surgery conducted over four weeks.

Detailed Description

Identification of high-risk surgical patients requires risk stratification. Current clinical risk stratification tools, e.g. Revised Cardiac Risk Index (RCRI), only have a moderate ability to identify these patients. International guidelines, like Canadian Cardiovascular Society on perioperative cardiovascular risk assessment, advocate that all patients 45 yrs and older or patients \>18y rs who have significant cardiovascular disease and who are coming for intermediate to high-risk surgery, should get natriuretic peptide (NP) testing. This is because raised preoperative B-type natriuretic peptides have a strong association with postoperative cardiac complications according to observational studies and meta-analyses.

However, in these patients with significant cardiovascular disease coming for intermediate to high-risk surgery it is unknown how many patients will actually have raised B-type natriuretic peptides. That is, which group of patients have an even higher risk in this already high-risk group. Natriuretic peptide (NP) testing is also expensive.

Further identification of patients that need NP testing will reduce costs and focus efforts on those patients who really need it.

Study Timeline

• Study First Submitted: 2019-10-01
• Study First Submitted QC: 2019-10-01
• Study First Posted: 2019-10-03
• Study Start: 2019-10-14
• Primary Completion: 2020-04-01
• Study Completion: 2020-04-29
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-05
• Last Update Posted: 2020-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 174

Inclusion Criteria

1. Age ≥ 45 years of age.

2. Undergoing intermediate or major non-cardiac surgery requiring an overnight stay in hospital.

3. With at least one of the following criteria:

   1. History of ischaemic heart disease or peripheral vascular disease (coronary equivalent)
   2. History of stroke or transient ischaemic attack
   3. History of congestive cardiac failure
   4. Diabetes currently on an oral hypoglycaemic agent or insulin
   5. Serum creatinine >175 µmol/L (>2.0mg/dl)

Exclusion Criteria

1. Patient refusal to participate.
2. Patients presenting for cardiac and obstetric or emergency surgery.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Raised natriuretic peptide	preoperative	Determine the prevalence of abnormal (raised) NP in patients with clinical risk criteria.

Secondary Outcome Measures

Name	Time	Method
Risk prediction	preoperative	The secondary objective is to develop a risk prediction model for those patients who will need preoperative NP screening.

Trial Locations

Locations (1)

Groote Schuur Hospital; 🇿🇦 Cape Town, Western Cape, South Africa