BNP Evaluation Before Surgery Study: an Observational Study of Natriuretic Peptide Levels Prior to Surgery. (EPIC-2)

Evaluating Perioperative Interventions to Improve Patient outComes (EPIC-2): BNP Evaluation Before Surgery Study

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

Study Overview

• Status: Completed
• Conditions: Surgery, Cardiovascular

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 Type: Observational
• Enrollment (Actual): 174

Contacts and Locations

Study Locations

• South Africa
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7935
      • Groote Schuur Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study population comprises all non-cardiac patients 45yrs presenting for elective surgery at Groote Schuur-, Somerset-, Paarl-, Victoria-, Mitchell's Plain-, Worcester-, and George Hospital over a period four weeks.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

High-risk elective surgical patients; The patient population to be studied are elective patients for non-cardiac surgery.; Age ≥ 45 years of age.; Undergoing intermediate or major non-cardiac surgery requiring an overnight stay in hospital.; With at least one of the following criteria:History of ischaemic heart disease or peripheral vascular disease (coronary equivalent)History of stroke or transient ischaemic attackHistory of congestive cardiac failureDiabetes currently on an oral hypoglycaemic agent or insulinSerum creatinine >175 µmol/L (>2.0mg/dl)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Raised natriuretic peptide	Determine the prevalence of abnormal (raised) NP in patients with clinical risk criteria.	preoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk prediction	The secondary objective is to develop a risk prediction model for those patients who will need preoperative NP screening.	preoperative

Collaborators and Investigators

• Sponsor: University of Cape Town

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2019
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): April 29, 2020

Study Registration Dates

• First Submitted: October 1, 2019
• First Submitted That Met QC Criteria: October 1, 2019
• First Posted (Actual): October 3, 2019

Study Record Updates

• Last Update Posted (Actual): May 7, 2020
• Last Update Submitted That Met QC Criteria: May 5, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Risk stratification; High risk surgical patients; Natriuretic peptide testing
• Other Study ID Numbers: EPIC-2:BNP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No