Cardioplegic Protection of the Heart

February 9, 2026 updated by: Region Skane

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Lund, Sweden, 22242
        • Cardiothoracic surgery department, Skåne university hospital, Lund

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Buckberg cardioplegia
Drug: Modified Buckberg cardioplegic solution
Study subjects randomized to this study group will receive Modified Buckberg cardioplegic solution during coronary artery bypass grafting operation.
Active Comparator: St Thomas´ cardioplegia
Drug: Modified St Thomas´ cardioplegic solution
Study subjects randomized to this study group will receive Modified St Thomas hospital´s cardioplegic solution during coronary artery bypass grafting operation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CKMB
Time Frame: 48 hours after surgery (cross clamp release)
Peak plasma levels of Creatin kinase muscle brain 0,18-300 µg/L
48 hours after surgery (cross clamp release)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hs-cTnT
Time Frame: 48 hours after surgery (cross clamp release)
peak level of plasma hig sensitive cardiac Troponin T after surgery 3 - 10 000 ng/L
48 hours after surgery (cross clamp release)
hs-cTnI
Time Frame: 48 hours after surgery (cross clamp release)
peak plasma level of high sensitive cardiac Troponin I after surgery 2,50-25 000 ng/L
48 hours after surgery (cross clamp release)
Cardiometabolic protein profile
Time Frame: 2 hours after surgery
Levels of 92 cardiometabolic proteins analyzed with proximity extension assay technique before and two hours after surgery.
2 hours after surgery
Pacemaker
Time Frame: two hours after aortic cross clamp release
Rate of required use of temporary pacemaker after aortic cross clamp release
two hours after aortic cross clamp release
DC cardioversion
Time Frame: during the surgical procedure in the operating room
Rate of required use of direct current cardioversion to treat arrythmia after aortic cross clamp release
during the surgical procedure in the operating room

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Skane

Investigators

  • Principal Investigator: Snejana Hyllén, MD, Assistant Professor, Region Skane

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2021

Primary Completion (Actual)

November 18, 2021

Study Completion (Actual)

April 29, 2025

Study Registration Dates

First Submitted

January 28, 2026

First Submitted That Met QC Criteria

January 28, 2026

First Posted (Actual)

February 4, 2026

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 2021-01728

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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