Back to resultsImpact of Ascorbic Acid Treatment on the Development and Treatment of Vasodilation in Cardiac Surgery
Primary Purpose
Vasoplegia
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ascorbic Acid
Sponsored by
About this trial
This is an interventional treatment trial for Vasoplegia focused on measuring vasoplegia, cardiac surgery, ascorbic acid
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
All patients will receive ascorbic acid as this is a pilot study.
Outcomes
Primary Outcome Measures
Vasopressor duration in hours
Total duration of vasopressor therapy
Vasopressor dose
Total dose of vasopressor in norepinephrine equivalents (mcg)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03744702
Brief Title
Impact of Ascorbic Acid Treatment on the Development and Treatment of Vasodilation in Cardiac Surgery
Official Title
Pilot Study for Determining the Impact of Ascorbic Acid Treatment on the Development and Treatment of Vasodilation in Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
June 28, 2019 (Actual)
Primary Completion Date
February 5, 2021 (Actual)
Study Completion Date
February 5, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vasoplegia
Keywords
vasoplegia, cardiac surgery, ascorbic acid
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
All patients will receive ascorbic acid as this is a pilot study.
Intervention Type
Drug
Intervention Name(s)
Ascorbic Acid
Other Intervention Name(s)
Ascor
Intervention Description
Patients will receive IV ascorbic acid.
Primary Outcome Measure Information:
Title
Vasopressor duration in hours
Description
Total duration of vasopressor therapy
Time Frame
Up to 10 days following surgery
Title
Vasopressor dose
Description
Total dose of vasopressor in norepinephrine equivalents (mcg)
Time Frame
Up to 10 days following surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erica D Wittwer
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Impact of Ascorbic Acid Treatment on the Development and Treatment of Vasodilation in Cardiac Surgery
We'll reach out to this number within 24 hrs