Clinical trial NCT01444235: Phase III Study Comparing Two Methods of Cardioplegia in Coronary Artery Bypass Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Artery Disease (CAD)
Keywords: CAD, ACVB
Lead sponsor: Dr. F. Köhler Chemie GmbH
Sponsor class: INDUSTRY
First posted: 2011-09-30
Enrollment: 102
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: CK-MB area under the curve within 24 hours
timeFrame: Up to 24 hours after the aortic clamp release
Secondary outcomes:
measure: Catecholamine requirement
timeFrame: 24 hours (cumulative dose)
measure: CK-MB peak
timeFrame: Up to day 5
measure: Mortality any time during post-op through Day 30
timeFrame: Up to Day 30
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Klinik für Thorax- und Kardiovaskuläre Chirurgie, Universitätsklinikum Essen
city: Heidelberg
country: Germany
facility: Abt. Herzchirugie, Universitätsklinikum Heidelberg
city: Jena
country: Germany
facility: Klinik für Herz- und Thoraxchirurgie, Universitätsklinikum Jena
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
Study officials:
affiliation: Department of Cardiac Surgery of University of Heidelberg
name: Gabor Szabo, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinik für Thorax- und Kardiovaskuläre Chirurgie, Universitätsklinikum Essen
name: Nikolaus Pizanis, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinik für Herz- und Gefäßchirurgie, Universitäts-Krankenhaus Eppendorf
name: Florian Wagner, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinik für Herz- und Thoraxchirurgie, Universitätsklinikum Jena
name: Thorsten Doenst, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Herzzentrum Leipzig GmbH, Klinik für Herzchirurgie
name: Martin Misfeld, Dr.
role: PRINCIPAL_INVESTIGATOR
References: