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OpenTrials
Completed

NCT Number: NCT04114032

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

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

Completed

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Groote Schuur Hospital

Cape Town, Western Cape, 7935, South Africa

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Raised natriuretic peptide

    Time frame: preoperative

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

Secondary outcomes

  1. Risk prediction

    Time frame: preoperative

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

Sponsors and collaborators

Lead sponsor

University of Cape Town

Other

Registry information

Official study title

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

Acronym: EPIC-2

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 3, 2019
Registry last updated
May 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.