Vitamin C in Cardiac Surgery Patients

NCT03123107 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 2016-0463
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative atrial fibrillation (POAF) is a common complication following cardiac surgery that increases the incidence of stroke, kidney injury and death. Vitamin C has been shown to decrease the incidence of POAF follow cardiac surgery, but the optimal dose has not been identified. With this project, the investigators plan to gather pharmacokinetic and dose-response data for vitamin C in the cardiac surgery population. The investigators plan to conduct a small interventional pilot study investigating the pharmacokinetics and pharmacodynamics of Vitamin C in patients undergoing coronary artery bypass graft (CABG) surgery. Patients enrolled will receive an intravenous dose of Vitamin C the day before surgery and the day after. Patients will have blood samples obtained with each dose for analysis of vitamin C concentrations and several biomarkers of oxidative stress. Analysis of samples will be performed within the Department of Pharmaceutical Sciences at Wilkes University.

Conditions

Coronary Artery Bypass Graft Surgery

Keywords

Vitamin C; Postoperative atrial fibrillation; coronary artery bypass graft; ascorbic acid

Outcome Measures

Primary Outcomes (5)

• Ascorbate maximum serum concentration (Cmax)

  Maximum serum concentration of ascorbate obtained after drug administration.

  1 year

• Half-life of serum ascorbate (T1/2)

  The amount of time is takes for the serum concentration of ascorbate to decrease by half.

  1 year

• Elimination rate constant of ascorbate (Ke)

  The rate at which ascorbate is eliminated from the body

  1 year

• Area under the concentration-time curve for serum ascorbate (AUC)

  Describes the overall concentration in the body given an administered dose of ascorbic acid.

  1 year

• Change in biomarker concentrations

  This will consist of the concentrations of NADP+, NADPH, MDA, GGS and nitrotyrosine in blood and atrial tissue samples.

  Change within 24 hours; preoperative compared to postoperative

Study Arms (1)

Ascorbic Acid

EXPERIMENTAL

4 patients will receive 15 mg/kg of ascorbic acid IV the day before and after CABG surgery; 4 patients will receive 30 mg/kg of ascorbic acid IV the day before and after CABG surgery. The maximum dose of ascorbic acid will be 2 g.

Drug: Ascorbic Acid

Interventions

Ascorbic Acid DRUG

Ascorbic acid doses will be mixed in 100 mL normal saline and infused over 60 minutes. The postoperative dose will be given on postoperative day #1.

Also known as: Vitamin C

Ascorbic Acid

Eligibility Criteria

• Age: 21 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 21 to 79 years of age admitted to Geisinger Wyoming Valley (GWV) and scheduled to undergo urgent CABG
• Planned utilization of cardiopulmonary bypass during the surgical procedure

You may not qualify if:

• Body mass index greater than 30 kg/m2
• Estimated creatinine clearance less than 30 ml/min
• History of persistent or permanent atrial fibrillation
• Condition associated with oxidative stress or inflammation (e.g. chronic rheumatic, inflammatory or neoplastic disease, recent infection, etc.)
• Currently taking corticosteroids, non-steroidal anti-inflammatory drugs or deferoxamine
• History of oxalate kidney stones
• Currently pregnant
• History of allergic reaction to ascorbic acid products
• Currently taking any herbals or supplements (not including a multivitamin or calcium)
• Enrolled in another research study

Sponsors & Collaborators

• Geisinger Clinic: lead
• Wilkes University: collaborator

Study Sites (1)

Geisinger Wyoming Valley Medical Center

Wilkes-Barre, Pennsylvania, 18711, United States

Location

Related Publications (17)

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MeSH Terms

Interventions

Ascorbic Acid

Intervention Hierarchy (Ancestors)

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

Study Officials

• Deepak Singh, MD

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 5, 2017
• First Posted: April 21, 2017
• Study Start: July 6, 2017
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: June 16, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)