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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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03744702
Enrollment
15
Registered
2018-11-16
Start date
2019-06-28
Completion date
2021-02-05
Last updated
2021-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vasoplegia

Keywords

vasoplegia, cardiac surgery, ascorbic acid

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.

Interventions

DRUGAscorbic Acid

Patients will receive IV ascorbic acid.

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Vasopressor duration in hoursUp to 10 days following surgeryTotal duration of vasopressor therapy
Vasopressor doseUp to 10 days following surgeryTotal dose of vasopressor in norepinephrine equivalents (mcg)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026