Cardioplegic Protection of the Heart

NCT07386990 | Completed Phase 4

• 1 other identifier: 2021-01728
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• CKMB

  Peak plasma levels of Creatin kinase muscle brain 0,18-300 µg/L

  48 hours after surgery (cross clamp release)

Secondary Outcomes (5)

• hs-cTnT

  48 hours after surgery (cross clamp release)

• hs-cTnI

  48 hours after surgery (cross clamp release)

• Pacemaker

  two hours after aortic cross clamp release

• DC cardioversion

  during the surgical procedure in the operating room

• Cardiometabolic protein profile

  2 hours after surgery

Study Arms (2)

Buckberg cardioplegia

EXPERIMENTAL

Drug: Modified Buckberg cardioplegic solution

St Thomas´ cardioplegia

ACTIVE COMPARATOR

Drug: Modified St Thomas´ cardioplegic solution

Interventions

Modified Buckberg cardioplegic solution DRUG

Study subjects randomized to this study group will receive Modified Buckberg cardioplegic solution during coronary artery bypass grafting operation.

Buckberg cardioplegia

Modified St Thomas´ cardioplegic solution DRUG

Study subjects randomized to this study group will receive Modified St Thomas hospital´s cardioplegic solution during coronary artery bypass grafting operation.

St Thomas´ cardioplegia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for non urgent, single procedure coronary artery bypass grafting surgery at Skåne university hospital in Lund Sweden

You may not qualify if:

• 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.

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Cardiothoracic surgery department, Skåne university hospital, Lund

Lund, 22242, Sweden

Location

Study Officials

• Snejana Hyllén, MD, Assistant Professor

  Region Skåne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 4, 2026
• Study Start: June 15, 2021
• Primary Completion: November 18, 2021
• Study Completion: April 29, 2025
• Last Updated: February 12, 2026

Record last verified: 2026-01

Locations

SE (1)