- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03744702
Impact of Ascorbic Acid Treatment on the Development and Treatment of Vasodilation in Cardiac Surgery
Pilot Study for Determining the Impact of Ascorbic Acid Treatment on the Development and Treatment of Vasodilation in Cardiac Surgery
Study Overview
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 Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment
All patients will receive ascorbic acid as this is a pilot study.
|
Patients will receive IV ascorbic acid.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vasopressor duration in hours
Time Frame: Up to 10 days following surgery
|
Total duration of vasopressor therapy
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Up to 10 days following surgery
|
Vasopressor dose
Time Frame: Up to 10 days following surgery
|
Total dose of vasopressor in norepinephrine equivalents (mcg)
|
Up to 10 days following surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Erica D Wittwer, Mayo Clinic
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-003358
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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