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OpenTrials
Completed

NCT Number: NCT03612388

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

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).

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Key information

Conditions

Complication of Extracorporeal Circulation Complication of Coronary Artery Bypass Graft

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinik für Herzchirurgie, Universitätsspital Basel

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

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).

Primary outcomes

  1. 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)

Secondary outcomes

  1. mortality

    Time frame: 30 days after CABG

    death after coronary artery bypass grafting

  2. need for intensive care unit

    Time frame: perioperative during hospital stay for CABG

    duration of stay at intensive care unit

  3. dysrhythmia

    Time frame: perioperative during hospital stay for CABG

    rhythm disturbance after coronary artery bypass grafting

  4. bleeding

    Time frame: perioperative during hospital stay for CABG

    bleeding complication after coronary artery bypass grafting

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Acronym: MiECC

Important dates

Study start
2010
Primary completion
2018
Study completion
2019
First posted
Aug 2, 2018
Registry last updated
Jul 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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