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Impact of Ascorbic Acid Treatment on the Development and Treatment of Vasodilation in Cardiac Surgery

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT03744702
Collaborator
(none)
15
Enrollment
1
Location
1
Arm
19.3
Actual Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a prospective pilot study in which the effects of ascorbic acid administration are investigated in adult patients undergoing cardiac surgical procedures requiring cardiopulmonary bypass (CPB). Ascorbic acid (Vitamin C) is an essential cofactor in the biosynthesis of catecholamines, and critically ill patients are known to be ascorbate-deficient. In addition, cardiopulmonary bypass (CPB) decreases ascorbic acid concentrations. Cardiac vasoplegia is the loss of vascular tone despite adequate volume status and cardiac output, occurring commonly in patients after CPB. This necessitates the administration of vasopressors and alternative agents which can have deleterious effects. The administration of ascorbic acid to cardiac surgical patients may improve microcirculatory function, enhance endogenous catecholamine levels and decrease the need for exogenous vasopressor support.

Condition or Disease Intervention/Treatment Phase
  • Drug: Ascorbic Acid
 Early Phase 1

Detailed Description

  1. Specific Aims

The investigators aim to determine the feasibility of performing a study that can assess the impact of ascorbic acid administration on the development and severity of cardiac vasoplegia in cardiac surgical patients undergoing procedures at high risk for vasoplegia.

Specific Aim 1: 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.

Specific Aim 2: Determine baseline ascorbic acid plasma levels in a small cohort of cardiac surgical patients.

Specific Aim 3: Determine the impact of ascorbic acid administration on microvasculature as measured by dark field microscopy.

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pilot Study for Determining the Impact of Ascorbic Acid Treatment on the Development and Treatment of Vasodilation in Cardiac Surgery
Actual Study Start Date :
Jun 28, 2019
Actual Primary Completion Date :
Feb 5, 2021
Actual Study Completion Date :
Feb 5, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment

All patients will receive ascorbic acid as this is a pilot study.

Drug: Ascorbic Acid
Patients will receive IV ascorbic acid.
Other Names:
  • Ascor

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Vasopressor duration in hours [Up to 10 days following surgery]

      Total duration of vasopressor therapy

    2. Vasopressor dose [Up to 10 days following surgery]

      Total dose of vasopressor in norepinephrine equivalents (mcg)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:

    • 18 years of age or older

    • Undergoing cardiac surgery with the use of cardiopulmonary bypass

    • Undergoing myectomy or valve replacement/repair

    Exclusion criteria:

    • Coronary artery bypass grafting (CABG)

    • Circulatory arrest

    • Active infection or sepsis

    • Severe hepatic disease or ascites

    • Pre-operative renal dysfunction requiring dialysis

    • Pre-operative midodrine

    • Pre-operative oral or intravenous steroid use

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Erica D Wittwer, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Erica D. Wittwer, M.D., Ph.D., Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT03744702
    Other Study ID Numbers:
    • 18-003358
    First Posted:
    Nov 16, 2018
    Last Update Posted:
    Mar 11, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Erica D. Wittwer, M.D., Ph.D., Principal Investigator, Mayo Clinic
    vasoplegia
    cardiac surgery
    ascorbic acid
    Additional relevant MeSH terms:
    Vasoplegia
    Ascorbic Acid

    Study Results

    No Results Posted as of Mar 11, 2021