Impact of Ascorbic Acid Treatment on the Development and Treatment of Vasodilation in Cardiac Surgery
| Status: | Enrolling by invitation |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/8/2019 |
| Start Date: | April 2019 |
| End Date: | March 2020 |
Pilot Study for Determining the Impact of Ascorbic Acid Treatment on the Development and Treatment of Vasodilation in Cardiac Surgery
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.
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.
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.
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.
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
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