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

NCT ID: NCT01444235

Last Updated: 2013-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2012-07-31

Brief 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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Custodiol

After cross clamping of the aorta on cardiopulmonary bypass, the Custodiol solution, at a temperature of 4 - 6°C, will be infused antegrade into the root of the aorta.

Group Type: ACTIVE_COMPARATOR

Custodiol

Intervention Type: DRUG

Route of administration: by infusion duration: infusion technique will be continued for seven minutes dosage: until 1500-2000 mL of solution have been infused

Custodiol-N

After cross clamping of the aorta on cardiopulmonary bypass, the Custodiol-N solution, at a temperature of 4 - 6°C, will be infused antegrade into the root of the aorta.

Group Type: EXPERIMENTAL

Custodiol-N

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

The study population will be selected from patients of either sex with coronary artery disease (CAD) who are to undergo cardiopulmonary bypass for coronary artery bypass surgery.

1. Patients >/=35 and </=80 years of age

2. Male or female with 2 or 3 vessel coronary disease, who are scheduled for elective CBP surgery for coronary revascularisation

3. Presence of definite CAD for which surgical intervention is deemed necessary, without evidence of ongoing infarction.

Patients with unstable angina can be included as long as there is no objective (negative cardiac isoenzymes in the immediate six hours preceding CABG, current intravenous use of nitrate therapy) or subjective (absence of prolonged symptoms suggestive of coronary insufficiency that do not respond to pharmacologic intervention) evidence of myocardial necrosis.

4. Eligibility for Swan-Ganz-Catheter

5. Able to understand character and individual consequences of the clinical trial and to provide written informed consent to participate in the study

6. No evidence of severe organic or psychiatric disease by history or physical examination

7. No history of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or no any history of drug abuse or addiction within 12 months of study enrollment.

Exclusion Criteria

1. Patients undergoing valve repair or replacement

2. History of recent (< 6 weeks) Q-wave myocardial infarction

3. Left ventricular ejection fraction < 35% (as assessed by any one of the following: contrast ventriculography, multigated acquisition scanning [MUGA], or 2-D ECHO)

4. Patients on intra-aortic balloon devices or with history of previous coronary artery bypass surgery

5. Pregnant or lactating patients

6. Patients who have participated in any other investigational studies within 30 days previous to enrollment

7. Patients in cardiogenic shock (defined as a systolic BP < 90 mmHg for over one hour despite inotropic and chronotropic support)

8. Patients with severe chronic obstructive lung disease (FEV1 < 50%)

9. Previous cardiac valvular disease (clinical relevant)

10. Dialysis or creatinine > 2 mmol/L

11. BMS-Stent < 4 weeks

12. DES-Stent < 6 month

13. Guidance depended Plavix therapy

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr. F. Köhler Chemie GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gabor Szabo, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiac Surgery of University of Heidelberg

Nikolaus Pizanis, Dr.

Role: PRINCIPAL_INVESTIGATOR

Klinik für Thorax- und Kardiovaskuläre Chirurgie, Universitätsklinikum Essen

Florian Wagner, Dr.

Role: PRINCIPAL_INVESTIGATOR

Klinik für Herz- und Gefäßchirurgie, Universitäts-Krankenhaus Eppendorf

Thorsten Doenst, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Klinik für Herz- und Thoraxchirurgie, Universitätsklinikum Jena

Martin Misfeld, Dr.

Role: PRINCIPAL_INVESTIGATOR

Herzzentrum Leipzig GmbH, Klinik für Herzchirurgie

Locations

Klinik für Thorax- und Kardiovaskuläre Chirurgie, Universitätsklinikum Essen

Essen, , Germany

Abt. Herzchirugie, Universitätsklinikum Heidelberg

Heidelberg, , Germany

Klinik für Herz- und Thoraxchirurgie, Universitätsklinikum Jena

Jena, , Germany

Herzzentrum Leipzig GmbH

Leipzig, , Germany

Countries

Germany

Other Identifiers

CL-N-CSM-III/01/08

Identifier Type: -

Identifier Source: org_study_id