Coronary Artery Bypass Graft (CABG)Phase 4NCT07386990
Cardioplegic Protection of the Heart
A Phase 4 study testing Modified Buckberg cardioplegic solution and Modified St Thomas´ cardioplegic solution in people with Coronary Artery Bypass Graft (CABG) and Cardioplegia, run by Region Skane at 1 site in Sweden.
Trial summary
This study seek to compare two different solutions used to protect the heart during cardiac surgery. 40 adult patients planned for coronary artery bypass surgery with cardiopulmonary bypass machine assistance will be included in the study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Bypass Graft (CABG), Cardioplegia, Cardiopulmonary Bypass
- What is being tested?
- Modified Buckberg cardioplegic solution and Modified St Thomas´ cardioplegic solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 15 Jun 2021to 29 Apr 2025
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for non urgent, single procedure coronary artery bypass grafting surgery at Skåne university hospital in Lund Sweden
- Exclusion Criteria: Heart failure (=Left ventricular ejection fraction less than 40 %).
- Moderate and severe aortic valve insufficiency.
- Type 1 diabetes.
- Renal insufficiency (=estimated glomerular filtration rate <60 mL/min/1,73m2)
- Not communicating in Swedish language.
- Previous cardiac surgery.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Cardiothoracic surgery department, Skåne university hospital, Lund
Lund, 22242
About this study
Official title: The Type of Cardioplegia and Cardiometabolic Impact - a Prospective Randomized Trial in Patients Undergoing CABG
This study seek to compare two different solutions used to protect the heart during cardiac surgery. 40 adult patients planned for coronary artery bypass surgery with cardiopulmonary bypass machine assistance will be included in the study. Blood samples from the first 48 hours after surgery will be analyzed together with physical data, x-ray-results, ecg and general outcome after surgery.
- Conditions
- Coronary Artery Bypass Graft (CABG), Cardioplegia, Cardiopulmonary Bypass, Perioperative Myocardial Injury
- Being tested
- Modified Buckberg cardioplegic solution, Modified St Thomas´ cardioplegic solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Buckberg cardioplegic solutionDrug
Study subjects randomized to this study group will receive Modified Buckberg cardioplegic solution during coronary artery bypass grafting operation.
Modified St Thomas´ cardioplegic solutionDrug
Study subjects randomized to this study group will receive Modified St Thomas hospital´s cardioplegic solution during coronary artery bypass grafting operation.
| Study group | Role | What they receive |
|---|---|---|
| Buckberg cardioplegia | Experimental | Not described Receives: Drug: Modified Buckberg cardioplegic solution |
| St Thomas´ cardioplegia | Active comparator | Not described Receives: Drug: Modified St Thomas´ cardioplegic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
CKMB
Peak plasma levels of Creatin kinase muscle brain 0,18-300 µg/L
Measured: 48 hours after surgery (cross clamp release)
Secondary outcomes (5)
hs-cTnT
peak level of plasma hig sensitive cardiac Troponin T after surgery 3 - 10 000 ng/L
Measured: 48 hours after surgery (cross clamp release)
hs-cTnI
peak plasma level of high sensitive cardiac Troponin I after surgery 2,50-25 000 ng/L
Measured: 48 hours after surgery (cross clamp release)
Pacemaker
Rate of required use of temporary pacemaker after aortic cross clamp release
Measured: two hours after aortic cross clamp release
DC cardioversion
Rate of required use of direct current cardioversion to treat arrythmia after aortic cross clamp release
Measured: during the surgical procedure in the operating room
Cardiometabolic protein profile
Levels of 92 cardiometabolic proteins analyzed with proximity extension assay technique before and two hours after surgery.
Measured: 2 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start15 Jun 2021
- Primary completion18 Nov 2021
- Study completion29 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass Graft (CABG)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Snejana Hyllén, MD, Assistant Professor, Principal investigator, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07386990
- Sponsor's protocol ID
- 2021-01728
- Status last verified
- Jan 2026
- First submitted
- 28 Jan 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No