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

Coronary Artery Disease (CAD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01444235
• Other study ID #: CL-N-CSM-III/01/08
• Status: Completed
• Phase: Phase 2
• First received: September 29, 2011
• Last updated: May 16, 2013
• Start date: March 2011
• Est. completion date: July 2012

Study information

• Verified date: May 2013
• Source: Dr. F. Köhler Chemie GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Federal Institute for Drugs and Medical Devices(BfArM): Germany
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: July 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Disease (CAD)
• Coronary Disease
• Myocardial Ischemia

Intervention

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
• 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

Locations

Country	Name	City	State
Germany	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

Sponsors (1)

Lead Sponsor	Collaborator
Dr. F. Köhler Chemie GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CK-MB area under the curve within 24 hours	Measurements will be carried out at the following timepoints: 4,8,12,16,20,24 hours (± 30 min) after release of the aortic cross clamp	Up to 24 hours after the aortic clamp release	Yes
Secondary	Catecholamine requirement	Catecholamine requirement on surgical ICU within 24 hours	24 hours (cumulative dose)	Yes
Secondary	CK-MB peak	CK-MB peak on the days 2, 3, 4 and 5 after removal of aortic cross clamp	Up to day 5	Yes
Secondary	Mortality any time during post-op through Day 30	Mortality will be documented at any time during post-op through Day 30	Up to Day 30	Yes