Impact of Ascorbic Acid Treatment on the Development and Treatment of Vasodilation in Cardiac Surgery

Vasoplegia Clinical Trial

Official title:

Pilot Study for Determining the Impact of Ascorbic Acid Treatment on the Development and Treatment of Vasodilation in Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03744702
• Other study ID #: 18-003358
• Status: Completed
• Phase: Early Phase 1
• Start date: June 28, 2019
• Est. completion date: February 5, 2021

Study information

• Verified date: March 2021
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 5, 2021
• Est. primary completion date: February 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Vasoplegia

Intervention

Drug:
• Ascorbic Acid
Patients will receive IV ascorbic acid.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vasopressor duration in hours	Total duration of vasopressor therapy	Up to 10 days following surgery
Primary	Vasopressor dose	Total dose of vasopressor in norepinephrine equivalents (mcg)	Up to 10 days following surgery

External Links

•   Mayo Clinic Clinical Trials