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| [ ...Back to search results ] | [ Print-friendly version ] |
| Propofol cardioplegia for Myocardial Protection Trial: ProMPT |
| ISRCTN | ISRCTN84968882 |
| ClinicalTrials.gov identifier | |
| Public title | Propofol cardioplegia for Myocardial Protection Trial: ProMPT |
| Scientific title | A single-centre randomised controlled trial of propofol cardioplegia on blood and myocardial biomarkers of stress and injury in patients having isolated coronary artery bypass grafting (CABG) or aortic valve replacement (AVR) using cardiopulmonary bypass (CPB) |
| Acronym | ProMPT |
| Serial number at source | CS/2008/3029 |
| Study hypothesis |
The ProMPT trial aims to test the hypothesis that supplementation of the cardioplegic solution with propofol will be cardioprotective for patients undergoing isolated coronary artery bypass grafting (CABG) or aortic valve replacement surgery (AVR) with cardiopulmonary bypass (CPB).
Please note as of 01/02/2011 the start date of in this record was updated from 01/09/2009 to 15/02/2010 and the end date extended from 28/02/2012 to 31/03/2012. |
| Lay summary | |
| Ethics approval | 16th November 2009 (West Midlands) |
| Study design | Single-centre blinded placebo controlled randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Cardiac disease/coronary surgery |
| Participants - inclusion criteria |
Current inclusion criteria as of 01/02/2011:
1. Male or female 2. Age ≥18 to ≤80 years 3. Having elective or urgent CABG or AVR with CPB at the BHI 4. Able to give full informed consent for the study Previous inclusion criteria: 1. Male or female 2. Aged greater than or equal to 16 years to less than or equal to 80 years 3. Having elective or urgent CABG or AVR with CPB at the Bristol Heart Institute (BHI) 4. Able to give full informed consent for the study |
| Participants - exclusion criteria |
Current inclusion criteria as of 01/02/2011:
1. Previous cardiac surgery 2. Combined CABG and AVR 3. Emergency or salvage operation 4. Chronic renal failure requiring dialysis 5. Current congestive heart failure 6. Left ventricular ejection fraction less than 30% (i.e. poor LV function) 7. Allergy to peanuts, eggs, egg products, soybeans or soy products 8. Already participating in another clinical (interventional) study Previous inclusion criteria: 2. Concomitant CABG/AVR procedure |
| Anticipated start date | 15/02/2010 |
| Anticipated end date | 31/03/2012 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details provided in the interventions field to request a patient information sheet |
| Target number of participants | 96 |
| Interventions |
Eligible patients undergoing coronary artery bypass grafting (CABG) or aortic valve replacement (AVR) with cardiopulmonary bypass (CPB) and who consent to participate will be randomly allocated to either:
1. Control: cardioplegia with placebo (intralipid) supplementation. Warm blood cardioplegia will be used for CABG participants and cold blood cardioplegia for participants having AVR. 2. Intervention: cardioplegia with propofol supplementation (6 µg/ml). Warm blood cardioplegia will be used for participants having isolated CABG and cold blood cardioplegia for participants having AVR. Method of administration will be through either antegrade or retrograde cardioplegia delivery according to local protocol. Several 'doses' may be given but this varies according to the length of surgery time. The duration of treatment is the time on cardiopulmonary bypass and a 3-month postal health status questionnaire follow-up will be completed for all patients. Contact details for patient information sheet: Dr Zoe Plummer Clinical Trial Co-ordinator Bristol Heart Institute University of Bristol Level 7, Bristol Royal Infirmary Bristol BS2 8HW United Kingdom Email: zoe.plummer@bristol.ac.uk |
| Primary outcome measure(s) |
Current primary outcome measure(s) as of 01/02/2011:
The primary outcome will be myocardial injury, assessed by measuring myocardial Troponin T in serum from blood samples collected pre-operatively and at 1, 6, 12, 24 and 48 hours post chest closure. Previous primary outcome measure(s): Myocardial injury, assessed by measuring myocardial Troponin T in serum from blood samples collected pre-operatively and 1, 6, 12, 24 and 48 hours post cross-clamp release |
| Secondary outcome measure(s) |
Current secondary outcome measure(s) as of 01/02/2011:
1. Myocardial ischaemic stress assessed using biopsies taken from left and right ventricles immediately prior to aortic cross-clamping and 10 minutes post chest closure. Gene expression and cellular changes associated with stress and injury signalling pathways will be measured from metabolite/RNA extracts. 2. Systemic metabolic stress, assessed by measuring lactate in blood samples collected pre-operatively, 10 minutes after aortic chest closure and 1, 6, 12, 24 and 48 hours post chest closure. 3. Blood pH, measured using each sample collected for (b). 4. Renal function, assessed by measuring creatinine in serum from blood samples collected pre-operatively and 1, 6, 12, 24 and 48 hours post chest closure. 5. The concentration of plasma propofol, measured in blood samples collected immediately before aortic cross-clamping, once during cardioplegia (after blood/cardioplegia mixing) and 10 minutes post cross-clamp release. Blood will be taken from the cardioplegia/bypass circuit. 6. Length of intensive care unit (ICU)/high dependency unit (HDU) stay. 7. Clinical outcomes and serious adverse events, i.e. serious post-operative complications (e.g. myocardial infarction, permanent stroke, renal failure defined as new need for haemodialysis) and death from any cause. 8. Patient health status, monitored using specialist questionnaires administered pre-operatively and 3 months post-operatively. CABG patients will be asked to complete the Coronary Revascularisation Outcome Questionnaire (CROQ) and AVR patients will be asked to complete the Minnesota Living with Heart Failure (MLHF) Questionnaire. The EQ-5D™ health questionnaire will also be administered to all patients. Previous secondary outcome measure(s): 1. Myocardial ischaemic stress assessed using biopsies taken from left and right ventricles immediately prior to aortic cross-clamping and 10 minutes after cross-clamp release. Gene expression and cellular changes associated with stress and injury signalling pathways will be measured from metabolite/RNA extracts. 2. Systemic oxidative stress assessed by measuring 8-Isoprostane in serum from blood samples collected pre-operatively and 1, 6, 12, 24 and 48 hours post cross-clamp release 3. Systemic metabolic stress assessed by measuring lactate in blood samples collected pre-operatively, 10 minutes after aortic cross-clamp release and 1, 6, 12, 24 and 48 hours post cross-clamp release 4. Blood pH measured using each sample collected for point 3 above 5. The inflammatory response characterised by measuring IL-6, IL-8, IL-10, C3a, C5a, and TNF1alpha in serum from blood samples collected pre-operatively and 1, 6, 12, 24 and 48 hours post cross-clamp release 6. Renal function assessed by measuring creatinine in serum from blood samples collected pre-operatively and 1, 6, 12, 24 and 48 hours post cross-clamp release 7. Renal injury assessed by measuring Neutrophil Gelatinase Associated Lipocalin (NGAL) in serum from blood samples collected pre-operatively and at 1, 6, 12, 24 and 48 hours post cross-clamp release 8. The concentration of circulating microparticles measured in plasma from blood samples collected pre-operatively and 1, 6, 12, 24 and 48 hours post cross-clamp release 9. The concentration of plasma propofol measured in plasma from blood samples collected immediately before aortic cross-clamping, once during cardioplegia (after blood/cardioplegia mixing) and 10 minutes after cross-clamp release. Blood will be taken from the cardioplegia/bypass circuit. 10. Length of intensive care unit (ICU)/high dependency unit (HDU) stay will be recorded 11. Clinical outcomes and serious adverse events, i.e. serious post-operative complications (e.g. myocardial infarction, permanent stroke, renal failure defined as new need for haemodialysis) and death from any cause will be recorded 12. Patient health status monitored using specialist questionnaires pre-operatively and 3 months post-operatively. CABG patients will be asked to complete the Coronary Revascularisation Outcome Questionnaire (CROQ) and AVR patients will be asked to complete the Minnesota Living with Heart Failure (MLHF) Questionnaire. The EQ-5D™ health questionnaire will also be administered to all patients pre–operatively and at 3 months post-operatively. |
| Sources of funding | National Institute for Health Research (NIHR) (UK) - Biomedical Research Unit (ref: 2008/SS/BRU) |
| Trial website | |
| Publications | |
| Contact name | Mr Alan Bryan |
| Address |
Division of Specialised Services
University Hospitals Bristol NHS Foundation Trust Marlborough Street |
| City/town | Bristol |
| Zip/Postcode | BS2 8HW |
| Country | United Kingdom |
| alan.bryan@uhbristol.nhs.uk | |
| Sponsor | University Hospitals Bristol NHS Foundation Trust (UK) |
| Address |
Research and Effectiveness Department
Education Centre, Level 3 Upper Maudlin Street |
| City/town | Bristol |
| Zip/Postcode | BS2 8AE |
| Country | United Kingdom |
| mary.perkins@ubht.nhs.uk | |
| Sponsor website: | http://www.uhbristol.nhs.uk/ |
| Date applied | 18/08/2009 |
| Last edited | 01/02/2011 |
| Date ISRCTN assigned | 11/11/2009 |
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| © 2012 ISRCTN unless otherwise stated. | |
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