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Clinical Trials/NCT04114032
NCT04114032
Completed
Not Applicable

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

University of Cape Town1 site in 1 country174 target enrollmentOctober 14, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Surgery, Cardiovascular
Sponsor
University of Cape Town
Enrollment
174
Locations
1
Primary Endpoint
Raised natriuretic peptide
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 14, 2019
End Date
April 29, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Bruce Biccard

Second Chair, Department of Anaesthesia and Perioperative Medicine, Professor

University of Cape Town

Eligibility Criteria

Inclusion Criteria

  • 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 attack
  • History of congestive cardiac failure
  • Diabetes currently on an oral hypoglycaemic agent or insulin
  • Serum creatinine \>175 µmol/L (\>2.0mg/dl)

Exclusion Criteria

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

Outcomes

Primary Outcomes

Raised natriuretic peptide

Time Frame: preoperative

Determine the prevalence of abnormal (raised) NP in patients with clinical risk criteria.

Secondary Outcomes

  • Risk prediction(preoperative)

Study Sites (1)

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