Patients with aortic valve disease and has to undergo aortic valve surgery +/- bypass surgery.
Conditions
Interventions
Trade Name: Custodiol-N®
Product Name: Custodiol-N®
Pharmaceutical Form: Lyophilisate and solvent for solution for injection
CAS Number: 71-00-1
Other descriptive name: HISTIDINE
Concentration unit: m
Sponsors
Dr. Franz Köhler Chemie GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The study population will be selected from patients of either sex who are to undergo for aortic valve surgery (with and without coronary bypass surgery). (1) Patients >/=30 and =65 years) yes F.1.3.1 Number of subjects for this age range 190
Exclusion criteria
Exclusion criteria: (1) History of recent (< 6 weeks) Q-wave myocardial infarction (2) Left ventricular ejection fraction < 25% (as assessed by any one of the following: contrast ventriculography, multigated acquisition scanning [MUGA], or 2-D ECHO) (3) Patients on intra-aortic balloon devices or with history of previous coronary artery bypass surgery (4) Pregnant or lactating patients (5) Patients who have participated in any other investigational studies within 30 days previous to enrollment (6) Patients in cardiogenic shock (defined as a systolic BP < 90 mmHg for over one hour despite inotropic and chronotropic support) (7) Patients with severe chronic obstructive lung disease (FEV1 < 50%) (8) Previous cardiac valvular disease (clinical relevant) (9) GFR <60 ml/min (10) Planned Ross-procedure, Mitral valve surgery, Aortic valve reconstruction, double valve surgery, other concomitant operations excluding coronary artery bypass surgery or closing a patent foramen ovale (11) Evidence of severe organic (e.g. cirrhosis of the liver) or psychiatric disease by history or physical examination (12) History of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction within 12 months of study enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this investigation is to compare the cardioprotective effects and safety of two cardioplegic solutions, Custodiol and Custodiol-N in patients undergoing aortic valve surgery +/- bypass surgery.;Secondary Objective: to demonstrate superiority in surgical outcome of Custodiol-N compared with Custodiol as determined by CK-MB peak value between 4 - 24 hours after opening of the aortic cross-clamp (primary endpoint), catecholamine requirement (cumulative dose) and cardiac Troponin T, occurrence of comorbid events postoperatively (e.g., myocardial infarction);Primary end point(s): CK-MB peak value ;Timepoint(s) of evaluation of this end point: from 4 to 24 hours (measurements 4, 8, 12, 16, 20, 24 hours ± 30 min) after release of the aortic cross clamp | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Catecholamine requirement on SICU within 24 hours (cumulative dose) • CK-MB (peak) on the days 2, 3, 4 and 5 after removal of aortic cross clamp • Cardiac Troponin T 4, 8, 12, 16, 20, 24 hours ± 30 min and on the days 2, 3, 4 and 5 after release of the aortic cross clamp • CK-MB area under the curve between 4 and 24 hours after removal of the aortic cross-clamp • Troponin T area under the curve between 4 and 24 hours after removal of the aortic cross-clamp • Defibrillation • Requirement for IABP • Blood pressure • Length of SICU stay • Duration of mechanical ventilation (intubation to extubation) • Occurrence, severity, type, and duration of cardiac arrhythmias • Laboratory parameters • Repeated patient transfer to SICU • Mortality any time during post-op through Day 30 • Safety (documentation and reporting of AE and SAE) ;Timepoint(s) of evaluation of this end point: see above (Point E.5.2) | — |
Countries
Germany
Contacts
Public ContactDr. Roman Petrov
Dr. Franz Köhler Chemie GmbH
Outcome results
None listed