Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2026-03-03 @ 12:35 AM
Study NCT ID:
NCT04114032
Status:
COMPLETED
Last Update Posted:
2020-05-07
First Post:
2019-10-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BNP Evaluation Before Surgery Study: an Observational Study of Natriuretic Peptide Levels Prior to Surgery.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 174}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-04-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-05', 'studyFirstSubmitDate': '2019-10-01', 'studyFirstSubmitQcDate': '2019-10-01', 'lastUpdatePostDateStruct': {'date': '2020-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Raised natriuretic peptide', 'timeFrame': 'preoperative', 'description': 'Determine the prevalence of abnormal (raised) NP in patients with clinical risk criteria.'}], 'secondaryOutcomes': [{'measure': 'Risk prediction', 'timeFrame': 'preoperative', 'description': 'The secondary objective is to develop a risk prediction model for those patients who will need preoperative NP screening.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['High risk surgical patients', 'Risk stratification', 'Natriuretic peptide testing'], 'conditions': ['Surgery, Cardiovascular']}, 'descriptionModule': {'briefSummary': 'A prospective, multi-centre, observational study of preoperative natriuretic peptide testing for patients undergoing non-cardiac surgery conducted over four weeks.', 'detailedDescription': '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.\n\nHowever, 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.\n\nFurther identification of patients that need NP testing will reduce costs and focus efforts on those patients who really need it.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "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.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 45 years of age.\n2. Undergoing intermediate or major non-cardiac surgery requiring an overnight stay in hospital.\n3. With at least one of the following criteria:\n\n 1. History of ischaemic heart disease or peripheral vascular disease (coronary equivalent)\n 2. History of stroke or transient ischaemic attack\n 3. History of congestive cardiac failure\n 4. Diabetes currently on an oral hypoglycaemic agent or insulin\n 5. Serum creatinine \\>175 µmol/L (\\>2.0mg/dl)\n\nExclusion Criteria:\n\n1. Patient refusal to participate.\n2. Patients presenting for cardiac and obstetric or emergency surgery.'}, 'identificationModule': {'nctId': 'NCT04114032', 'acronym': 'EPIC-2', 'briefTitle': 'BNP Evaluation Before Surgery Study: an Observational Study of Natriuretic Peptide Levels Prior to Surgery.', 'organization': {'class': 'OTHER', 'fullName': 'University of Cape Town'}, 'officialTitle': 'Evaluating Perioperative Interventions to Improve Patient outComes (EPIC-2): BNP Evaluation Before Surgery Study', 'orgStudyIdInfo': {'id': 'EPIC-2:BNP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'High-risk elective surgical patients', 'description': 'The patient population to be studied are elective patients for non-cardiac surgery.\n\n1. Age ≥ 45 years of age.\n2. Undergoing intermediate or major non-cardiac surgery requiring an overnight stay in hospital.\n3. With at least one of the following criteria:\n\n 1. History of ischaemic heart disease or peripheral vascular disease (coronary equivalent)\n 2. History of stroke or transient ischaemic attack\n 3. History of congestive cardiac failure\n 4. Diabetes currently on an oral hypoglycaemic agent or insulin\n 5. Serum creatinine \\>175 µmol/L (\\>2.0mg/dl)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '7935', 'city': 'Cape Town', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Groote Schuur Hospital', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Undecided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cape Town', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Second Chair, Department of Anaesthesia and Perioperative Medicine, Professor', 'investigatorFullName': 'Bruce Biccard', 'investigatorAffiliation': 'University of Cape Town'}}}}