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

July 30, 2019 updated by: University Hospital, Basel, Switzerland

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

211

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • Klinik für Herzchirurgie, Universitätsspital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing isolated CABG (coronary artery bypass grafting) using MiECC (Minimal extracorporeal circulation system) at the department of cardial surgery University Hospital Basel Switzerland

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2010

Primary Completion (Actual)

March 31, 2018

Study Completion (Actual)

March 13, 2019

Study Registration Dates

First Submitted

July 17, 2018

First Submitted That Met QC Criteria

July 26, 2018

First Posted (Actual)

August 2, 2018

Study Record Updates

Last Update Posted (Actual)

July 31, 2019

Last Update Submitted That Met QC Criteria

July 30, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 2018-00926; ch18Reuthebuch3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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