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

• Sponsor: University Hospital, Basel, Switzerland (Other)
• Overall Status: Completed
• CT.gov ID: NCT03612388
• Collaborator: (none)
• Enrollment: 211
• Location: 1
• Actual Duration (Months): 108.4
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Complication of Extracorporeal Circulation; Complication of Coronary Artery Bypass Graft	Procedure: use of a cardioplegic formula in isolated CABG (coronary artery bypass grafting) using MiECC (Minimal extracorporeal circulation

Study Design

• Study Type: Observational
• Actual Enrollment: 211 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Combined Use of a Novel Cardioplegic Formula With MPS® Versus Cardioplexol ® in Isolated CABG Using MiECC (Minimal Extracorporeal Circulation System)
• Actual Study Start Date: Feb 28, 2010
• Actual Primary Completion Date: Mar 31, 2018
• Actual Study Completion Date: Mar 13, 2019

Arms and Interventions

Arm	Intervention/Treatment
cardioplegia with MPS® (Myocardial protection system) cardioplegic formula with MPS® (Myocardial protection system); use of a cardioplegic formula in isolated CABG (coronary artery bypass grafting) using MiECC (Minimal extracorporeal circulation	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).
cardioplegia with Cardioplexol ® cardioplegic formula with Cardioplexol ® (colloid solution with Procaine, magnesium and potassium)

Outcome Measures

Primary Outcome Measures

1. 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

1. mortality [30 days after CABG]

   death after coronary artery bypass grafting

2. need for intensive care unit [perioperative during hospital stay for CABG]

   duration of stay at intensive care unit

3. dysrhythmia [perioperative during hospital stay for CABG]

   rhythm disturbance after coronary artery bypass grafting

4. bleeding [perioperative during hospital stay for CABG]

   bleeding complication after coronary artery bypass grafting

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Klinik für Herzchirurgie, Universitätsspital Basel	Basel		Switzerland	4031

Sponsors and Collaborators

• University Hospital, Basel, Switzerland

Investigators

• Principal Investigator: Oliver Reuthebuch, PD MD, University Hospital Basel, CH-4031 Basel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Basel, Switzerland
• ClinicalTrials.gov Identifier: NCT03612388
• Other Study ID Numbers: 2018-00926; ch18Reuthebuch3
• First Posted: Aug 2, 2018
• Last Update Posted: Jul 31, 2019
• Last Verified: Jul 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 31, 2019