A Study to Determine the Impact of Ascorbic Acid Treatment on Vasodilation in Cardiac Surgery
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 18-003358
NCT ID: NCT03744702
Sponsor Protocol Number: 18-003358
About this study
The purpose of the study is to determine the feasibility of administration of high dose intravenous ascorbic acid in the operative and post-operative environments as well as sample size for a prospective, randomized, placebo controlled study.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Greater than 18 years of age.
- Presenting for cardiac surgery at Mayo Clinic in Rochester, Minnesota.
- Scheduled to undergo cardiac surgery with the use of cardiopulmonary bypass involving myectomy or valve replacement/repair.
Exclusion Criteria:
- Cases involving planned coronary artery bypass grafting (CABG).
- Cases requiring circulatory arrest.
- Active infection or sepsis.
- Severe hepatic disease or ascites.
- Pre-operative renal dysfunction requiring dialysis.
- Preoperative midodrine, oral steroid, or intravenous steroid use. Inhaled steroids are not an exclusion criteria.
- Pregnancy and glucose-6-phosphate dehydrogenase (G6PD) deficiency.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available