MedTrace Logo

Vitamin C in Cardiac Surgery Patients

NCT03123107 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2021-06-16

No results posted yet for this study

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

Interventions

DRUG

Ascorbic Acid

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.

Sponsors & Collaborators

  • Wilkes University

    collaborator OTHER

  • Geisinger Clinic

    lead OTHER

Principal Investigators

  • Deepak Singh, MD · Geisinger Clinic

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-06
Primary Completion
2019-05-31
Completion
2019-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03123107 on ClinicalTrials.gov