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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03744702
Other study ID # 18-003358
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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