Custodiol-HTK (Histidine-tryptophan-ketoglutarate) Solution as a Cardioplegic Agent
Launched by MARC SAKWA, MD · Sep 4, 2012
Trial Information
Current as of May 08, 2025
Completed
Keywords
ClinConnect Summary
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.
Gender
ALL
Eligibility 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.
About Marc Sakwa, Md
Dr. Marc Sakwa, MD, is a distinguished clinical trial sponsor known for his commitment to advancing medical research and improving patient outcomes. With extensive experience in clinical practice and a strong focus on innovative therapeutic approaches, Dr. Sakwa leads and oversees a diverse portfolio of clinical trials across various medical disciplines. His dedication to rigorous scientific methodologies and ethical standards ensures that each study is designed to yield reliable data while prioritizing participant safety. Dr. Sakwa's collaborative approach fosters partnerships with leading research institutions and healthcare professionals, enhancing the overall impact of his research initiatives on the medical community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Royal Oak, Michigan, United States
Patients applied
Trial Officials
Marc Sakwa, M.D.
Principal Investigator
Beaumont Health
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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