Combined Use of a Novel Cardioplegic Formula With Myocardial Protection System (MPS)® Versus Cardioplexol ® in Isolated Coronary Artery Bypass Grafting (CABG) Using MiECC;

Completed

• Conditions: Complication of Coronary Artery Bypass Graft; Complication of Extracorporeal Circulation
• Interventions: Procedure: use of a cardioplegic formula in isolated CABG (coronary artery bypass grafting) using MiECC (Minimal extracorporeal circulation

• Registration Number: NCT03612388
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

Combined use of a novel cardioplegic formula with MPS® (Myocardial protection system) versus Cardioplexol ® (colloid solution with Procaine, magnesium and potassium) in isolated CABG (coronary artery bypass grafting) using MiECC (Minimal extracorporeal circulation system).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-28
• Primary Completion: 2018-03-31
• Study First Submitted: 2018-07-17
• Study First Submitted QC: 2018-07-26
• Study First Posted: 2018-08-02
• Study Completion: 2019-03-13
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-30
• Last Update Posted: 2019-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 211

Inclusion Criteria

• CABG using MPS® or Cardioplexol ®

Exclusion Criteria

• use of other colloid solution than Cardioplexol ® or MPS®
• other inventions than CABG
• myocardial infarction <7 days before CABG
• patients denial of data use

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
cardioplegia with MPS® (Myocardial protection system)	use of a cardioplegic formula in isolated CABG (coronary artery bypass grafting) using MiECC (Minimal extracorporeal circulation	cardioplegic formula with MPS® (Myocardial protection system); use of a cardioplegic formula in isolated CABG (coronary artery bypass grafting) using MiECC (Minimal extracorporeal circulation

Primary Outcome Measures

Name	Time	Method
Change in lab values for cardial biomarkers	perioperative during hospital stay for CABG	cardial biomarkers measured are high sensitive troponin T (hs-TrT), Creatinkinase, (CK) Creatinkinase myocardial type (CK-MB)

Secondary Outcome Measures

Name	Time	Method
need for intensive care unit	perioperative during hospital stay for CABG	duration of stay at intensive care unit
bleeding	perioperative during hospital stay for CABG	bleeding complication after coronary artery bypass grafting
mortality	30 days after CABG	death after coronary artery bypass grafting
dysrhythmia	perioperative during hospital stay for CABG	rhythm disturbance after coronary artery bypass grafting

Trial Locations

Locations (1)

Klinik für Herzchirurgie, Universitätsspital Basel; 🇨🇭 Basel, Switzerland