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.: PACTR201806003460336 Date of Approval: 12/06/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Impact of dexmedetomidine on postoperative biomarkers, length of hospitalisation and mortality in patients undergoing coronary artery bypass graft su
Official scientific title Impact of dexmedetomidine on postoperative biomarkers, length of hospitalisation and mortality in patients undergoing coronary artery bypass graft surgery
Brief summary describing the background and objectives of the trial Cardiovascular disease case-fatality was postulated to be higher in sub-Saharan Africa compared with other countries due to limited access to health care. Coronary artery bypass graft surgery, a surgical procedure performed to alleviate the symptoms of ischaemic heart disease and improve prognosis, is not without adverse events. Trials on the cardioprotective effects of anaesthetic agents have included studies targeting the effects of ischaemia-reperfusion, the neurohumoral response and ischaemic preconditioning. Dexmedetomidine, an alpha 2 adrenergic agonist, is a newer drug in this class that has gained interest in investigations of myocardial protection due to its pharmacological profile. A randomised, controlled, double-blind parallel group trial was undertaken to investigate the effects of dexmedetomidine on myocardial ischaemia and short-term outcomes.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied cardiovascular disease,Circulatory System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/02/2014
Actual trial start date 01/02/2014
Anticipated date of last follow up 31/08/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 90
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
M170985 Human Research Ethics Committee of the University of the Witwatersrand
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation using a radomisation table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Dexmedetomidine 0.3 - 0.7 mcg/kg/hr Preinduction to 2-4 hours post operatively Dexmedetomidine 45
Control Group Saline 0.3 - 0.7 mcg/kg/hr visually Preinduction to 2-4 hours post operatively Placebo 45
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Left main or triple vessel coronary artery disease. 2. Age above 18 and below 65 years. 1. Age below 18 or above 65 years. 2. Pregnancy or lactation. 3. Liver dysfunction (AST or ALT > twice the upper range of normal). Normal values (National Health Laboratory Services: AST 5¿40 and ALT 5¿40 units/dl). 4. Sick sinus syndrome. 5. Use of concomitant medication with potential for major drug interactions such as propoxyphene, sodium oxybate and tinazide. 6. Patients requiring preoperative inotropic support. 7. Asthma. 8. Uncontrolled pulmonary congestion as evidenced radiologically and by arterial hypoxemia. 9. Evidence of ongoing infection as indicated by acute phase reaction markers. 10. Patients undergoing combined coronary and valve surgery, or other open heart procedures. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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
Yes 01/11/2013 University of the Witwatersrand HREC
Ethics Committee Address
Street address City Postal code Country
7 York Street Johannesburg 2000 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome hs-cTnT 24 hours post induction
Secondary Outcome 2. Length of ICU stay (days). 99 days
Secondary Outcome 3. Length of hospitalisation (days). 99 days
Secondary Outcome 4. 30-day postoperative mortality. 30 days
Secondary Outcome 5. 1-year mortality. 1 year
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of the Witwatersrand 7 York Street Johannesburg 2000 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
South African Medical Research Council Stellenbosch Cape Towm South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Palesa Mot 31 Melrose Street Johannesburg 2096 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Richard Nethononda Chris Hani Road Johannesburg 2000 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Palesa Motshabi-Chakane motshabi.chakane@gmail.com 0824321994 31 Melrose street
City Postal code Country Position/Affiliation
Johannesburg 2096 South Africa Anaesthesiology
Role Name Email Phone Street address
Public Enquiries Chris Lundgren chris.lundgren@wits.ac.za 0119339334 Chris Hani Baragwanath hospital
City Postal code Country Position/Affiliation
Johannesburg 2000 South Africa Supervisor
Role Name Email Phone Street address
Scientific Enquiries Richard Nethononda mashudu.nethononda@wits.ac.za 0119338197 Chris Hani Baragwanath hospital
City Postal code Country Position/Affiliation
Johannesburg 2000 South Africa Supervisor
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