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

NCT03744702 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 18-003358
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Vasoplegia

Keywords

vasoplegia; cardiac surgery; ascorbic acid

Outcome Measures

Primary Outcomes (2)

• Vasopressor duration in hours

  Total duration of vasopressor therapy

  Up to 10 days following surgery

• Vasopressor dose

  Total dose of vasopressor in norepinephrine equivalents (mcg)

  Up to 10 days following surgery

Study Arms (1)

Treatment

EXPERIMENTAL

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

Drug: Ascorbic Acid

Interventions

Ascorbic Acid DRUG

Patients will receive IV ascorbic acid.

Also known as: Ascor

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Undergoing cardiac surgery with the use of cardiopulmonary bypass
• Undergoing myectomy or valve replacement/repair

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Wieruszewski PM, Radosevich MA, Nei SD, Kashani KB, Normand SE, Schaff HV, Wittwer ED. Ascorbic acid and microcirculation in cardiothoracic surgery: a pilot feasibility trial and matched cohort study. J Cardiothorac Surg. 2025 May 22;20(1):234. doi: 10.1186/s13019-025-03486-8.

  PMID: 40400032 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Vasoplegia

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Erica D Wittwer

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: November 16, 2018
• Study Start: June 28, 2019
• Primary Completion: February 5, 2021
• Study Completion: February 5, 2021
• Last Updated: March 11, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)