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

Complication of Coronary Artery Bypass Graft Clinical Trial

— MiECC  

Official title:

Combined Use of a Novel Cardioplegic Formula With MPS® Versus Cardioplexol ® in Isolated CABG Using MiECC (Minimal Extracorporeal Circulation System)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03612388
• Other study ID #: 2018-00926; ch18Reuthebuch3
• Status: Completed
• Start date: February 28, 2010
• Est. completion date: March 13, 2019

Study information

• Verified date: July 2019
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: March 13, 2019
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Complication of Coronary Artery Bypass Graft
• Complication of Extracorporeal Circulation

Intervention

Procedure:
• use of a cardioplegic formula in isolated CABG (coronary artery bypass grafting) using MiECC (Minimal extracorporeal circulation
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).

Locations

Country	Name	City	State
Switzerland	Klinik für Herzchirurgie, Universitätsspital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in lab values for cardial biomarkers	cardial biomarkers measured are high sensitive troponin T (hs-TrT), Creatinkinase, (CK) Creatinkinase myocardial type (CK-MB)	perioperative during hospital stay for CABG
Secondary	mortality	death after coronary artery bypass grafting	30 days after CABG
Secondary	need for intensive care unit	duration of stay at intensive care unit	perioperative during hospital stay for CABG
Secondary	dysrhythmia	rhythm disturbance after coronary artery bypass grafting	perioperative during hospital stay for CABG
Secondary	bleeding	bleeding complication after coronary artery bypass grafting	perioperative during hospital stay for CABG