Clincosm LogoSign in Get a demo

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

Sponsor
University of Cape Town (Other)
Overall Status
Completed
CT.gov ID
NCT04114032
Collaborator
(none)
174
Enrollment
1
Location
6.5
Actual Duration (Months)
26.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    174 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluating Perioperative Interventions to Improve Patient outComes (EPIC-2): BNP Evaluation Before Surgery Study
    Actual Study Start Date :
    Oct 14, 2019
    Actual Primary Completion Date :
    Apr 1, 2020
    Actual Study Completion Date :
    Apr 29, 2020

    Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Raised natriuretic peptide [preoperative]

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

    Secondary Outcome Measures

    1. Risk prediction [preoperative]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    4. History of ischaemic heart disease or peripheral vascular disease (coronary equivalent)

    5. History of stroke or transient ischaemic attack

    6. History of congestive cardiac failure

    7. Diabetes currently on an oral hypoglycaemic agent or insulin

    8. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Groote Schuur Hospital Cape Town Western Cape South Africa 7935

    Sponsors and Collaborators

    • University of Cape Town

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bruce Biccard, Second Chair, Department of Anaesthesia and Perioperative Medicine, Professor, University of Cape Town
    ClinicalTrials.gov Identifier:
    NCT04114032
    Other Study ID Numbers:
    • EPIC-2:BNP
    First Posted:
    Oct 3, 2019
    Last Update Posted:
    May 7, 2020
    Last Verified:
    May 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Bruce Biccard, Second Chair, Department of Anaesthesia and Perioperative Medicine, Professor, University of Cape Town
    High risk surgical patients
    Risk stratification
    Natriuretic peptide testing

    Study Results

    No Results Posted as of May 7, 2020