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

Phase 2

Completed

• Conditions: Coronary Artery Disease (CAD)
• Interventions: Drug: Custodiol; Drug: Custodiol-N

• Registration Number: NCT01444235
• Lead Sponsor: Dr. F. Köhler Chemie GmbH

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).

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-09-29
• Study First Submitted QC: 2011-09-29
• Study First Posted: 2011-09-30
• Primary Completion: 2012-05
• Study Completion: 2012-07
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-16
• Last Update Posted: 2013-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Custodiol	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.
Custodiol-N	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.

Primary Outcome Measures

Name	Time	Method
CK-MB area under the curve within 24 hours	Up to 24 hours after the aortic clamp release	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

Secondary Outcome Measures

Name	Time	Method
Catecholamine requirement	24 hours (cumulative dose)	Catecholamine requirement on surgical ICU within 24 hours
CK-MB peak	Up to day 5	CK-MB peak on the days 2, 3, 4 and 5 after removal of aortic cross clamp
Mortality any time during post-op through Day 30	Up to Day 30	Mortality will be documented at any time during post-op through Day 30

Trial Locations

Locations (4)

Klinik für Herz- und Thoraxchirurgie, Universitätsklinikum Jena; 🇩🇪 Jena, Germany

Herzzentrum Leipzig GmbH; 🇩🇪 Leipzig, Germany

Abt. Herzchirugie, Universitätsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany

Klinik für Thorax- und Kardiovaskuläre Chirurgie, Universitätsklinikum Essen; 🇩🇪 Essen, Germany