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
- Are there results?
- None posted in the registry
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.
- More trials run by Region SkaneThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Type of Cardioplegia and Cardiometabolic Impact - a Prospective Randomized Trial in Patients Undergoing CABG
- ClinicalTrials.gov ID
- NCT07386990
- Acronym / sponsor ID
- 2021-01728
- Conditions
- Coronary Artery Bypass Graft (CABG), Cardioplegia, Cardiopulmonary Bypass, Perioperative Myocardial Injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 18 Nov 2021 (actual)
- Study completion
- 29 Apr 2025 (actual)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buckberg cardioplegia | Experimental | Drug: Modified Buckberg cardioplegic solution |
| St Thomas´ cardioplegia | Active comparator | Drug: Modified St Thomas´ cardioplegic solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Buckberg cardioplegic solutionStudy subjects randomized to this study group will receive Modified Buckberg cardioplegic solution during coronary artery bypass grafting operation. | Drug | Buckberg cardioplegia |
| Modified St Thomas´ cardioplegic solutionStudy subjects randomized to this study group will receive Modified St Thomas hospital´s cardioplegic solution during coronary artery bypass grafting operation. | Drug | St Thomas´ cardioplegia |
Primary outcome
CKMB
Time frame: 48 hours after surgery (cross clamp release)
Peak plasma levels of Creatin kinase muscle brain 0,18-300 µg/L
5 secondary outcomes
hs-cTnT
Time frame: 48 hours after surgery (cross clamp release)
hs-cTnI
Time frame: 48 hours after surgery (cross clamp release)
Pacemaker
Time frame: two hours after aortic cross clamp release
DC cardioversion
Time frame: during the surgical procedure in the operating room
Cardiometabolic protein profile
Time frame: 2 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
Related trials for Coronary Artery Bypass Graft (CABG)
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
RecruitingEarly Phase 1
Thiamine Intervention and Coronary Artery Bypass Grafting
Coronary Heart Disease, Coronary Artery Bypass Grafting
Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Anaesthetic Management in Patients Undergoing Coronary Artery Bypass Grafting
Preoperative Fasting, Pulmonary Aspiration During Anesthetic Induction
Active, not recruiting
Investigation of the Effects of Respiratory Muscle Training Combined With Otago Exercises in Elderly Patients Undergoing Coronary Artery Bypass Graft Surgery
Coronary Artery Bypass Graft (CABG)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Snejana Hyllén, MD, Assistant Professor principal investigator
Region Skane
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CKMB (time frame: 48 hours after surgery (cross clamp release)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.