Custodiol-AV: Phase III Study Comparing Two Methods of Cardioplegia in Aortic Valve Surgery Custodiol-N Versus Custodiol

• Sponsor: Dr. F. Köhler Chemie GmbH (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02098772
• Collaborator: (none)
• Enrollment: 530
• Locations: 6
• Arms: 2
• Actual Duration (Months): 55
• Patients Per Site: 88.3
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

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 aortic valve surgery. The study design is a prospective, double blind, multicenter, randomized, Phase III comparison study intended to demonstrate superiority in surgical outcome between Custodiol and Custodiol-N as determined by CK-MB peak value 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).

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Disease; Coronary Artery Disease (CAD)	Drug: Custodiol-N; Drug: Custodiol	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 530 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Prospective Randomized Double Blind Multicenter Phase III Study Comparing Two Methods of Cardioplegia in Aortic Valve Surgery Custodiol-N Versus Custodiol
• Actual Study Start Date: May 1, 2014
• Actual Primary Completion Date: Nov 16, 2018
• Actual Study Completion Date: Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Custodiol-N comparison of two cardioplegic solutions, Custodiol-N versus Custodiol, in aortic valve surgery	Drug: Custodiol-N; comparison of two cardioplegic solutions, Custodiol-N versus Custodiol, in aortic valve surgery
Active Comparator: Custodiol comparison of two cardioplegic solutions, Custodiol-N versus Custodiol, in aortic valve surgery	Drug: Custodiol; comparison of two cardioplegic solutions, Custodiol-N versus Custodiol, in aortic valve surgery

Outcome Measures

Primary Outcome Measures

1. peak value for CK-MB [measured at 4, 8, 12, 16, 20 and 24 hours after the release of the aortic cross clamp]

Secondary Outcome Measures

1. Catecholamine requirement on SICU [within 24 hours (cumulative dose)]

Other Outcome Measures

1. Safety parameters [from time of the study inclusion up to the follow-up visit on day 5]

   documentation and reporting of AE and SAE

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients >/= 30 and </= 85 years of age

• Male or female with aortic valve disease

• Able to understand character and individual consequences of the clinical trial and to provide written informed consent to participate in the study

• Women of childbearing potential (ie, those who have not undergone a hysterectomy or who have not been post-menopausal for at least 12 consecutive months) must test negative for pregnancy prior to bypass surgery.

Exclusion Criteria:

• History of recent (< 6 weeks) Q-wave myocardial infarction

• Left ventricular ejection fraction < 25% (as assessed by any one of the following: contrast ventriculography, multigated acquisition scanning [MUGA], or 2-D ECHO)

• Patients on intra-aortic balloon devices or with history of previous coronary artery bypass surgery

• Pregnant or lactating patients

• Patients who have participated in any other investigational studies within 30 days previous to enrollment

• Patients in cardiogenic shock (defined as a systolic BP < 90 mmHg for over one hour despite inotropic and chronotropic support)

• Patients with severe chronic obstructive lung disease (FEV1 < 50%)

• Previous cardiac valvular disease (clinical relevant)

• GFR <60 ml/min

• 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

• Evidence of severe organic (e.g. cirrhosis of the liver) or psychiatric disease by history or physical examination

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Klinik für Herzchirurgie, Universitätsklinikum Heidelberg	Heidelberg	Baden-Württemberg	Germany	69120
2	Klinik für Herz- und Gefäßchirurgie GmbH, Herz-Kreislauf-Zentrum Rotenburg	Rotenburg an der Fulda	Hessen	Germany	36199
3	Klinik für Herzchirurgie Universität Leipzig/ Herzzentrum Leipzig	Leipzig	Sachsen	Germany	04289
4	Klinik für Herz- und Thoraxchirurgie Universitätsklinikum Jena	Jena	Thüringen	Germany	07747
5	Klinik für Thorax-, Herz- und Gefäßchirurgie, Uniklinik der RWTH Aachen	Aachen		Germany	52074
6	Klinik für Gefäßchirurgie, Universitäres Herzzentrum am UKE Hamburg	Hamburg		Germany	20246

Sponsors and Collaborators

• Dr. F. Köhler Chemie GmbH

Investigators

• Principal Investigator: Gabor Szabó, Prof., Department of Cardiac Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. F. Köhler Chemie GmbH
• ClinicalTrials.gov Identifier: NCT02098772
• Other Study ID Numbers: CL-N-CSM-AV-III/05/12
• First Posted: Mar 28, 2014
• Last Update Posted: Jan 18, 2020
• Last Verified: Feb 1, 2018

• Keywords provided by Dr. F. Köhler Chemie GmbH: aortic valve disease; coronary bypass surgery; cardioplegic solutions
• Additional relevant MeSH terms: Coronary Artery Disease; Aortic Valve Disease

Study Results

No Results Posted as of Jan 18, 2020