Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201609001780323 Date of Approval: 13/09/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The BETTER Surgery Pilot Trial
Official scientific title A prospective, multi-centre, randomised pilot trial of natriuretic peptide guided therapy to improve clinical outcomes for patients undergoing non-cardiac surgery
Brief summary describing the background and objectives of the trial Annually 230 million adults undergo major non-cardiac surgery. In patients 45 years and older the 30-day mortality rate is 2%, and 8% have significant myocardial injury that contributes to subsequent morbidity. Myocardial injury and subsequent morbidity and mortality in cardiac patients going for non-cardiac surgery therefore represents a major health burden. The recently updated ACC/AHA algorithm and ESC/ESA guidelines place importance on the Revised Cardiac Risk Index (RCRI). Both incorporate the RCRI which only has a moderate discriminatory ability to identify patients at high risk of cardiac events. It is necessary to identify those patients at risk for Myocardial Injury after Noncardiac Surgery (MINS), and optimise them before the intended surgery. Current literature has identified natriuretic peptides (NP) as the most useful tool in identifying patients at risk. This is a prospective, multi-centre, randomised pilot trial of NP guided therapy to improve clinical outcomes for patients undergoing non-cardiac surgery. Primary Objectives: 1) Determine the feasibility of recruiting patients undergoing intermediate or major non-cardiac surgery to an RCT of NP directed medical therapy prior to non-cardiac surgery as compared to standard of care. 2) Determine the resources required to achieve recruitment, pre-operative randomization, and to conduct a full scale trial. 3) Assess the compliance with the trial protocol. Secondary Objectives: The secondary objectives are to collect preliminary data on the incidence of 30 day mortality, nonfatal myocardial infarction, nonfatal cardiac arrest, congestive cardiac failure and myocardial injury after noncardiac surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) BETTER
Disease(s) or condition(s) being studied Perioperative outcomes
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 02/01/2017
Actual trial start date 01/03/2017
Anticipated date of last follow up 28/09/2018
Actual Last follow-up date 28/09/2018
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a randomisation table created by a computer software program Central randomisation by phone/fax Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a randomisation table created by a computer software program Central randomisation by phone/fax Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a randomisation table created by a computer software program Central randomisation by phone/fax Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Natriuretic peptide directed changes to medical therapy Changes to medical therapy directed by natriuretic peptide levels Two to six weeks Preventative 25
Control Group Standard of care Changes to medical therapy directed by accepted guidelines Two to six weeks Preventative 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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 4 criteria: a. History of ischaemic heart disease b. History of peripheral vascular disease c. History of stroke; OR d. Any 3 of the following 9 criteria:History of congestive cardiac failure, transient ischaemic attack, diabetes and currently on an oral hypoglycaemic agent or insulin, age¿70yrs, hypertension, serum creatinine >175 µmol/L (>2.0mg/dl), history of smoking within 2 years of surgery. 1. Patient refusal to participate. 2. Where clinical opinion suggests that surgery cannot be postponed for at least 2 weeks to allow for clinical response to a change in medical therapy. 3. Percutaneous coronary intervention within the last two weeks. 45 Year(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 19/09/2016 Human Reasearch Ethics Committee
Ethics Committee Address
Street address City Postal code Country
E 53 Room 46, Old Main Building, Groote Schuur Hospital, Observatory Cape Town 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Determine feasibility of recruiting patients undergoing noncardiac surgery to RCT of NP directed medical therapy prior to noncardiac surgery as compared to standard of care (defined as recruitment of 50 patients in one year). After full patient recruitment
Primary Outcome Determine resources required to achieve recruitment, pre-operative randomization, and to conduct a full scale trial. After full patient recruitment
Primary Outcome Assess compliance with trial protocol (defined as >90% complete follow up at 30 days postoperatively) after full patient recruitment
Secondary Outcome Incidence of 30 day mortality, nonfatal myocardial infarction, nonfatal cardiac arrest, congestive cardiac failure and myocardial injury after noncardiac surgery After full patient recruitment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Anaesthesia, Inkosi Albert Luthuli Hospital Bellair Road Durban 4058 South Africa
Clinical Research Center Observatory Cape Town 7925 South Africa
Deaprtment of Anaesthesia, Grey's Hospital Townbush road Pietermaritzburg 3200 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
South African Society of Anaesthesiology Research grant South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Clinical Research Center Observatory Cape Town 7925 South Africa Hospital
COLLABORATORS
Name Street address City Postal code Country
Dr Christella Alphonsus Inkosi Albert Luthuli Hospital, Bellair road Durban 4058 South Africa
Dr Reitze Rodseth Grey's Hospital, Townbush road Pietermaritzburg 3200 South Africa
Professor Bruce Biccard Groote Schuur Hospital, Observatory Cape Town South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Christella Alphonsus csalphonsus@gmail.com (031) 240 2450 Inkosi Albert Luthuli hospital, Bellair road
City Postal code Country Position/Affiliation
Durban 4058 South Africa
Role Name Email Phone Street address
Public Enquiries Delva Shamley delva.shamley@uct.ac.za 0743775287 Clinical research Center, Groote Schuur Hospital
City Postal code Country Position/Affiliation
Cape Town South Africa
Role Name Email Phone Street address
Scientific Enquiries Bruce Biccard bruce.biccard@uct.ac.za 0761606387 Groote Schuur, Observatory
City Postal code Country Position/Affiliation
Cape town South Africa
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information