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

Early Phase 1

Completed

• Conditions: Vasoplegia
• Interventions: Drug: Ascorbic Acid

• Registration Number: NCT03744702
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2018-11-14
• Study First Submitted QC: 2018-11-15
• Study First Posted: 2018-11-16
• Study Start: 2019-06-28
• Primary Completion: 2021-02-05
• Study Completion: 2021-02-05
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-10
• Last Update Posted: 2021-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Ascorbic Acid	All patients will receive ascorbic acid as this is a pilot study.

Primary Outcome Measures

Name	Time	Method
Vasopressor duration in hours	Up to 10 days following surgery	Total duration of vasopressor therapy
Vasopressor dose	Up to 10 days following surgery	Total dose of vasopressor in norepinephrine equivalents (mcg)

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States