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

NCT ID: NCT04114032

Last Updated: 2020-05-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 174 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-14
• Study Completion Date: 2020-04-29

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.

Conditions

Surgery, Cardiovascular

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

High-risk elective surgical patients

The patient population to be studied are elective patients for non-cardiac surgery.

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)

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cape Town

OTHER

Sponsor Role: lead

Responsible Party

Bruce Biccard

Second Chair, Department of Anaesthesia and Perioperative Medicine, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Groote Schuur Hospital

Cape Town, Western Cape, South Africa

Countries

South Africa

Other Identifiers

EPIC-2:BNP

Identifier Type: -

Identifier Source: org_study_id