Influence of Vitamin C on Post-operative Atrial Fibrillation

Influence of Oral Vitamine C Supplementation on the Incidence of Post-operative Atrial Fibrillation

Post-operative atrial fibrillation (POAF) is the most common arrhythmia which typically develops 2-3 days after cardiac surgery. The incidence of POAF variates between 10% and 65% depending on the type of cardiac surgery and is especially high in patients which underwent Coronary Artery Bypass Grafting (CABG) and heart valve surgery. POAF is associated with increased morbidity and mortality and has a major impact on hospital resources.

The precise pathogenesis of POAF is very complex, but several studies have demonstrated an association between inflammation, oxidative stress and POAF. Since this oxidative stress may be reduced by dietary anti-oxidantia such as vitamin C, the aim of this study is to evaluate the effect of oral vitamin C administration of the incidence of POAF.

Study Overview

• Status: Unknown
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Dietary supplement: Vitamin C; Other: Placebo

Detailed Description

After obtaining informed consent, patients which are planned for CABG or heart valve surgery are randomly assigned into the Vitamin C group or Placebo Group.

Each patient will receive 1 g Vitamin C or Placebo twice a day from 5 days before until 10 days after surgery. The medication will be given orally and both patient and surgeon are blinded for the administrated medication.

Patients receive standard of care in the post-operative period, which includes close monitoring for possible arrhythmias. If such an arrhythmia develops, this is treated according to the normal procedures. All information such as the used medication, the hospitalization / ICU length of stay and the ventilation time is automatically registered in the patient records.

From each patient, three additional blood samples (peri-operative, post-operative Day 0, post-operative Day 1) will be obtained for analysis of Neutrophil gelatinase-associated lipocalin (NGAL), a possible marker of subclinical kidney damage. These samples will be analysed in batch once all samples are collected.

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alain F Kalmar, MD,PhD,MSc; Phone Number: +32 246 17 00; Email: alain.kalmar@gmail.com
• Study Contact Backup: Name: Nicky Van Der Vekens, DVM,PhD,MSc; Phone Number: +32 246 17 09; Email: nicky.vandervekens@azmmsj.be

Study Locations

• Belgium
  • Oost-Vlaanderen
    • Gent, Oost-Vlaanderen, Belgium, 9000
      • Recruiting
      • AZ Maria Middelares
      • Contact: Kathleen Stam; Email: kathleen.stam@azmmsj.be
      • Sub-Investigator: Jan Heerman, MD, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• signed informed consent
• eligible for elective cardiac surgery
• preoperative sinus rhythm

Exclusion Criteria:

• patients who do not want to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Vitamin C; Vitamin C 1000mg PO from 5 days before surgery until 10 days after surgery	Dietary supplement: Vitamin C; 1 gram Vitamin C will be administrated orally, twice a day from 5 days before until 10 days after surgery.
Placebo Comparator: Placebo; Placebo as an alternative for Vitamin C tablets	Other: Placebo; 1 gram Placebo will be administrated orally, twice a day, from 5 days before until 10 days after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arrhythmia	Incidence	First 5 days postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hours of endotracheal ventilation	number of hours of endotracheal ventilation after surgery	from arrival at ICU after surgery until the time of discharge from ICU. average 48 hours.
Length of stay at ICU	number of hours in the Intensive Care Unit	from time of arrival at ICU after surgery until the time of discharge from ICU. upto 14 days. average 48 hours.
Length of stay in the hospital	number of hours in the hospital	from time of arrival at ICU after surgery until the time of hospital discharge. upto 120 days.
Cost of postoperative medication	Total cost (€) of postoperative medication	from time of arrival at ICU after surgery until the time of hospital discharge. upto 120 days
subclinical kidney damage	change in Value of NGAL between pre-incision and post-CPB	after induction of anesthesia and two hours after CPB
Postoperative complications	Number of unexpected complications requiring medical interventions	from time of arrival at ICU until the time of hospital discharge. upto 120 days

Collaborators and Investigators

• Sponsor: Algemeen Ziekenhuis Maria Middelares
• Investigators: Principal Investigator: Alain F Kalmar, MD, PhD, MSc, Maria Middelares Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: June 22, 2018
• First Submitted That Met QC Criteria: July 18, 2018
• First Posted (Actual): July 19, 2018

Study Record Updates

• Last Update Posted (Actual): March 12, 2019
• Last Update Submitted That Met QC Criteria: March 11, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Ascorbic Acid; Vitamin C; Cardiac surgery; antioxidant; Post-operative atrial fibrillation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Ascorbic Acid
• Other Study ID Numbers: MMS.2017.011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No