Surgery, CardiovascularEPIC-2NCT04114032
BNP Evaluation Before Surgery Study: an Observational Study of Natriuretic Peptide Levels Prior to Surgery.
An observational study of Surgery, Cardiovascular, run by University of Cape Town at 1 site in South Africa.
Trial summary
A prospective, multi-centre, observational study of preoperative natriuretic peptide testing for patients undergoing non-cardiac surgery conducted over four weeks. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Surgery, Cardiovascular
- Type of treatment
- Pill or oral medicine
- How many people
- 174 participants
- Where
- 1 siteSouth Africa
- Study dates
- 14 Oct 2019to 29 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- Patient refusal to participate.
- Patients presenting for cardiac and obstetric or emergency surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Keywords
- High risk surgical patients, Risk stratification, Natriuretic peptide testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Raised natriuretic peptide
Determine the prevalence of abnormal (raised) NP in patients with clinical risk criteria.
Measured: preoperative
Secondary outcomes (1)
Risk prediction
The secondary objective is to develop a risk prediction model for those patients who will need preoperative NP screening.
Measured: preoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start14 Oct 2019
- Primary completion1 Apr 2020
- Study completion29 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery, CardiovascularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cape Town
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruce Biccard, University of Cape Town
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114032
- Sponsor's protocol ID
- EPIC-2:BNP
- Acronym
- EPIC-2
- Status last verified
- May 2020
- First submitted
- 1 Oct 2019
- Last updated
- 7 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Perioperative Interventions to Improve Patient outComes (EPIC-2): BNP Evaluation Before Surgery Study
- ClinicalTrials.gov ID
- NCT04114032
- Acronym / sponsor ID
- EPIC-2 / EPIC-2:BNP
- Conditions
- Surgery, Cardiovascular
- Keywords
- High risk surgical patients, Risk stratification, Natriuretic peptide testing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- University of Cape TownUniversity, hospital or other
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 29 Apr 2020 (actual)
- First posted
- 3 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (2 listed)
- Patient refusal to participate.
- Patients presenting for cardiac and obstetric or emergency surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Raised natriuretic peptide
Time frame: preoperative
Determine the prevalence of abnormal (raised) NP in patients with clinical risk criteria.
1 secondary outcome
Risk prediction
Time frame: preoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2020.
- Individual participant dataSharing planned: Undecided. Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery, Cardiovascular, run by University of Cape Town at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Raised natriuretic peptide (time frame: preoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2020.