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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-28

Study Completion Date

2021-02-05

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Vasoplegia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

All patients will receive ascorbic acid as this is a pilot study.

Group Type EXPERIMENTAL

Ascorbic Acid

Intervention Type DRUG

Patients will receive IV ascorbic acid.

Interventions

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Ascorbic Acid

Patients will receive IV ascorbic acid.

Intervention Type DRUG

Other Intervention Names

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Ascor

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No