Determining the Impact of Ascorbic Acid Treatment on Vasodilation in Cardiac Surgery

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes 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.
  • 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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  1. Greater than 18 years of age
  2. Presenting for cardiac surgery at Mayo Clinic in Rochester, Minnesota
  3. Scheduled to undergo cardiac surgery with the use of cardiopulmonary bypass involving myectomy or valve replacement/repair

 

Exclusion Criteria:

  1. Cases involving planned coronary artery bypass grafting (CABG)
  2. Cases requiring circulatory arrest
  3. Active infection or sepsis
  4. Severe hepatic disease or ascites
  5. Pre-operative renal dysfunction requiring dialysis
  6. Preoperative midodrine, oral steroid, or intravenous steroid use. Inhaled steroids are not an exclusion criteria.
  7. Pregnancy and glucose-6-phosphate dehydrogenase (G6PD) deficiency

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Erica Wittwer, M.D., Ph.D.

Open for enrollment

Contact information:

Laurie Meade R.N.

(507)255-1829

Meade.Laurie@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20441686

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