Combined Use of a Novel Cardioplegic Formula With MPS ® Using the MiECC in Isolated CABG Versus OPCABG

Completed

• Conditions: Complication of Extracorporeal Circulation; Complication of Coronary Artery Bypass Graft

• Registration Number: NCT03609723
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

A patient group receiving a novel cardioplegic formula with MPS ® (Myocardial protection system) and using the MiECC (Minimal extracorporeal circulation system) when undergoing coronary artery bypass grafting is compared to a retrospective patient group undergoing Off-pump coronary artery bypass grafting.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-12
• Study First Submitted: 2018-07-17
• Study First Submitted QC: 2018-07-25
• Study First Posted: 2018-08-01
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-31
• Last Update Posted: 2019-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2433

Inclusion Criteria

• CABG using MPS® or OPCABG

Exclusion Criteria

• use of other colloid solution than Cardioplexol ® for 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

Primary Outcome Measures

Name	Time	Method
assessment of cardial biomarkers as high sensitive troponin T (hs-TrT), Creatinkinase (CK) and Creatinkinase myocardial type (CK-MB)	perioperative during hospital stay for CABG	high sensitive troponin T (hs-TrT), Creatinkinase, (CK) Creatinkinase myocardial type (CK-MB)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Herzchirurgie University Hospital Basel; 🇨🇭 Basel, Switzerland