NCT01444235

Phase III Study Comparing Two Methods of Cardioplegia in Coronary Artery Bypass Surgery

A Prospective Randomized Double Blind Multicenter Phase III Study Comparing Two Methods of Cardioplegia in Coronary Artery Bypass Surgery Custodiol-N Versus Custodiol

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Dr. F. Köhler Chemie GmbH · Industry
• Sex: All
• Age: 35 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Comparison of the cardioprotective effects and safety of two cardioplegic solutions (solutions used during a cardiac arrest in the heart surgery) in patients undergoing cardiopulmonary bypass for coronary artery bypass surgery.

Detailed description

The objective of this investigation is to compare the cardioprotective effects and safety of two cardioplegic solutions, HTK Cardioplegic Solution (Custodiol) and Custodiol-N in patients undergoing cardiopulmonary bypass for coronary artery bypass surgery. The study design is a prospective, double blind, multicenter, randomized, Phase III comparison study intended to demonstrate non-inferiority in surgical outcome between Custodiol and Custodiol-N as determined by CK-MB area under the curve (primary endpoint), catecholamine requirement(cumulative dose) and cardiac Troponin T, occurrence of comorbid events postoperatively (e.g., myocardial infarction).

Conditions

• Coronary Artery Disease (CAD)

Interventions

Type	Name	Description
DRUG	Custodiol-N	Route of administration: by infusion Dosage: will be infused antegrade into the root of the aorta until 1500-2000 mL of solution have been infused Duration: infusion technique will be continued for seven minutes
DRUG	Custodiol	Route of administration: by infusion duration: infusion technique will be continued for seven minutes dosage: until 1500-2000 mL of solution have been infused

Timeline

• Start date: 2011-03-01
• Primary completion: 2012-05-01
• Completion: 2012-07-01
• First posted: 2011-09-30
• Last updated: 2013-05-17

Locations

4 sites across 1 country: Germany