Propofol in cardiac surgery: ProMPT-2

Phase 2

• Conditions: Reperfusion injury of the heart following coronary artery bypass grafting (CABG) surgery; Circulatory System

• Registration Number: ISRCTN15255199
• Lead Sponsor: niversity of Bristol

Brief Summary

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36794486/ (added 17/02/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-26
• Last Update Posted: 11 March 2024
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1. Aged >= 18 years
2. Having elective or urgent isolated CABG with CPB
3. Ability to give informed consent
Women only:
4. Negative pregnancy test, or be surgically or post-menopausal for >12 months

Exclusion Criteria

Current participant exclusion criteria as of 20/05/2020:
1. Previous cardiac surgery
2. Planned concomitant procedure
3. Emergency or salvage operation
4. Long-term steroid therapy (taking tablets on a daily basis for at least 1 month prior to
surgery)
5. Pre-operative estimated glomerular filtration rate = 30 ml/min/1.73m2
6. Current congestive heart failure
7. Left ventricular (LV) ejection fraction <30% (i.e. poor LV function)
8. Allergy to peanuts, eggs, egg products, soybeans or soy products
9. Already participating in another interventional clinical study
10. Prisoners
11. Patients taking immunosuppressants (e.g. methotrexate or azathioprine)
12. Patients known to have cTnT level >500 ng/l (or cTnI level >600 ng/l) in the last 4 days (prior to eligibility check)
Women only:
13. Breast feeding

Previous participant exclusion criteria:
1. Previous cardiac surgery
2. Planned concomitant procedure
3. Emergency or salvage operation
4. Long-term steroid therapy
5. Pre-operative estimated glomerular filtration rate < = 60 mls/min/1.73m2
6. Current congestive heart failure
7. Left ventricular (LV) ejection fraction < 30% (i.e. poor LV function)
8. Allergy to peanuts, eggs, egg products, soybeans or soy products
9. Already participating in another interventional clinical study
10. Prisoners

Women only:
11. Breastfeeding

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Myocardial injury, assessed by serial measurements of cTnT in serum from blood samples collected pre-operatively and during the first 48-hours post chest closure.