A Prospective Randomized Double Blind Multicenter Phase III Study Comparing two Methods of Cardioplegia in Coronary Artery Bypass Surgery Custodiol-N versus Custodiol
- Conditions
- The study population will be selected from both genders with coronary artery disease (CAD) who are to undergo cardiopulmonary bypass for coronary artery bypass surgery. The ratio of incidence for bypass surgery in the population is 4:1 (men:women) and reflects the normal allocation/distribution of cases of the disease in the population.MedDRA version: 14.0Level: PTClassification code 10011078Term: Coronary artery diseaseSystem Organ Class: 10007541 - Cardiac disorders
- Registration Number
- EUCTR2008-005992-81-DE
- Lead Sponsor
- Dr. F. Köhler Chemie GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
(1) Patients >/=35 and (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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
(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
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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;Secondary Objective: 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).;Primary end point(s): Primary Endpoint: <br><br>• CK-MB area under the curve within 24 hours (measurements 4,8,12,16,20,24 hours ± 30 min) after release of the aortic cross clamp<br>
- Secondary Outcome Measures
Name Time Method