Custodiol-HTK Solution as a Cardioplegic Agent
Information source: William Beaumont Hospitals
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Valvular Heart Disease
Intervention: Custodiol HTK (Drug); Cold Blood Cardioplegia (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Marc Sakwa, MD Official(s) and/or principal investigator(s): Marc Sakwa, M.D., Principal Investigator, Affiliation: Beaumont Health System
Summary
The purpose of the study is to demonstrate that Custodiol-HTK is not inferior to cold
cardioplegic solution in patients undergoing cardiovascular surgery requiring cardioplegic
arrest.
Clinical Details
Official title: Custodiol-HTK Solution as a Cardioplegic Agent- A Prospective Non-Inferiority Randomized Clinical Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Creatine phosphokinase MB isoenzyme (CK-MB)and troponin-IChanges in ejection fraction by TTE
Secondary outcome: Cardiac dysrhythmiasAll cause mortality Time on Mechanically Assisted Ventilation Biochemical Markers - Creatine phosphokinase MB isoenzyme (CK-MB)and troponin Duration of Vasopressor / Inotropic Agent ICU Length of Stay Arterial Blood Gases Creatinine Levels Myocardial Infarction
Detailed description:
The objective of this study is to demonstrate that Custodiol is not inferior to cold
cardioplegic solution for myocardial protection by comparing standard cold blood
cardioplegia to Custodiol solution with respect to myocardial injury as measured by Creatine
phosphokinase MB isoenzyme (CK-MB),troponin-I at 7 hours post surgery and changes in
ejection fraction by trans-thoracic echocardiogram (TTE)or trans-esophageal echocardiogram
(TEE) at 24 hours post surgery.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients undergoing scheduled cardiac surgery requiring cardioplegic arrest with
expected cross clamp time>45 minutes
- Patients age 18 and older
Exclusion Criteria:
- Pregnant women*
- Urgent or emergent cases
- Repeat cardiovascular surgical procedures
- Patients on dialysis
- Any known allergies to components of either cardioplegia solution *All women of child
bearing potential must have a negative serum or urine pregnancy test.
Locations and Contacts
William Beaumont Hospital, Royal Oak, Michigan 48073, United States
Additional Information
Related publications: Braathen B, Jeppsson A, Scherstén H, Hagen OM, Vengen Ø, Rexius H, Lepore V, Tønnessen T. One single dose of histidine-tryptophan-ketoglutarate solution gives equally good myocardial protection in elective mitral valve surgery as repetitive cold blood cardioplegia: a prospective randomized study. J Thorac Cardiovasc Surg. 2011 Apr;141(4):995-1001. doi: 10.1016/j.jtcvs.2010.07.011. Epub 2010 Aug 30. Careaga G, Salazar D, Téllez S, Sánchez O, Borrayo G, Argüero R. Clinical impact of histidine-ketoglutarate-tryptophan (HTK) cardioplegic solution on the perioperative period in open heart surgery patients. Arch Med Res. 2001 Jul-Aug;32(4):296-9. Hachida M, Ookado A, Nonoyama M, Koyanagi H. Effect of HTK solution for myocardial preservation. J Cardiovasc Surg (Torino). 1996 Jun;37(3):269-74. Yang Q, He GW. Effect of cardioplegic and organ preservation solutions and their components on coronary endothelium-derived relaxing factors. Ann Thorac Surg. 2005 Aug;80(2):757-67. Review. Beyersdorf F, Krause E, Sarai K, Sieber B, Deutschländer N, Zimmer G, Mainka L, Probst S, Zegelman M, Schneider W, et al. Clinical evaluation of hypothermic ventricular fibrillation, multi-dose blood cardioplegia, and single-dose Bretschneider cardioplegia in coronary surgery. Thorac Cardiovasc Surg. 1990 Feb;38(1):20-9. Savini C, Camurri N, Castelli A, Dell'Amore A, Pacini D, Suarez SM, Grillone G, Di Bartolomeo R. Myocardial protection using HTK solution in minimally invasive mitral valve surgery. Heart Surg Forum. 2005;8(1):E25-7. Braathen B, Tønnessen T. Cold blood cardioplegia reduces the increase in cardiac enzyme levels compared with cold crystalloid cardioplegia in patients undergoing aortic valve replacement for isolated aortic stenosis. J Thorac Cardiovasc Surg. 2010 Apr;139(4):874-80. doi: 10.1016/j.jtcvs.2009.05.036. Epub 2009 Jul 26. Hendrikx M, Jiang H, Gutermann H, Toelsie J, Renard D, Briers A, Pauwels JL, Mees U. 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Retrograde cardioplegia does not adequately perfuse the right ventricle. J Thorac Cardiovasc Surg. 1995 Jun;109(6):1116-24; discussion 1124-6. Sakata J, Morishita K, Ito T, Koshino T, Kazui T, Abe T. Comparison of clinical outcome between histidine-triptophan-ketoglutalate solution and cold blood cardioplegic solution in mitral valve replacement. J Card Surg. 1998 Jan;13(1):43-7. Lee D. H., Park N. H., Keum D. Y., Choi S. Y., Lee K. S., Yoo Y. S. Comparison of Myocardial Protective Effect between the Cold Blood Cardioplegia and Histidine-Tryptophan-Ketoglutarate Solution.Korean J Thorac Cardiovasc Surg. 2004;37(9):739-41. Kim S. , Lee Y. S. , Woo J. S. , Sung S. C. , Choi P. J. , Cho G. J., Bang J. H., Roh M. S. Histidine-tryptophan-ketoglutarate Versus Blood Cardioplegic Solutions: A Prospective, Myocardial Ultrastructural Study.Korean J Thorac Cardiovasc Surg. 2007;40(1):8-16. Choi Y. S., Bang S. O. , Chang B. C. , Lee S. , Park C. H. , Kwak Y. L. A Comparison of the Effects of Histidine-tryptophan-ketoglutarate Solution versus Cold Blood Cardioplegic Solution on Myocardial Protection in Mitral Valve Surgery.Korean J Thorac Cardiovasc Surg. 2007;40(6):399-406 Asano H, Kyo S, Ogiwara M, Tsunemoto M, Yokote Y, Omoto R, Koike K, Kobayashi T, Kobayashi J, Taketazu M. [Single-dose and high-volume Bretschneider cardioplegic solution for congenital heart surgery]. Kyobu Geka. 1999 Jan;52(1):82-6. Japanese.
Starting date: August 2012
Last updated: June 24, 2014
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