Clinical trial NCT03744702: 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
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Vasoplegia
Keywords: vasoplegia
cardiac surgery
ascorbic acid
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-11-16
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Vasopressor duration in hours
timeFrame: Up to 10 days following surgery
measure: Vasopressor dose
timeFrame: Up to 10 days following surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Erica D Wittwer
role: PRINCIPAL_INVESTIGATOR
References: