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Completed

NCT Number: NCT03744702

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

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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Key information

Conditions

Vasoplegia Cardiovascular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ascorbic acid

Drug

Patients will receive IV ascorbic acid.

Other names: Ascor

Primary outcomes

  1. Vasopressor duration in hours

    Time frame: Up to 10 days following surgery

    Total duration of vasopressor therapy

  2. Vasopressor dose

    Time frame: Up to 10 days following surgery

    Total dose of vasopressor in norepinephrine equivalents (mcg)

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 16, 2018
Registry last updated
Mar 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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