NCT03592680

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable atrial-fibrillation

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 19, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

March 12, 2019

Status Verified

March 1, 2019

Enrollment Period

2.7 years

First QC Date

June 22, 2018

Last Update Submit

March 11, 2019

Conditions

Atrial Fibrillation

Keywords

Post-operative atrial fibrillationAscorbic AcidVitamin CantioxidantCardiac surgery

Outcome Measures

Primary Outcomes (1)

  • Arrhythmia

    Incidence

    First 5 days postoperatively

Secondary Outcomes (6)

  • hours of endotracheal ventilation

    from arrival at ICU after surgery until the time of discharge from ICU. average 48 hours.

  • Length of stay at ICU

    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

    from time of arrival at ICU after surgery until the time of hospital discharge. upto 120 days.

  • Cost of postoperative medication

    from time of arrival at ICU after surgery until the time of hospital discharge. upto 120 days

  • subclinical kidney damage

    after induction of anesthesia and two hours after CPB

  • +1 more secondary outcomes

Study Arms (2)

Vitamin C

ACTIVE COMPARATOR

Vitamin C 1000mg PO from 5 days before surgery until 10 days after surgery

Dietary Supplement: Vitamin C

Placebo

PLACEBO COMPARATOR

Placebo as an alternative for Vitamin C tablets

Other: Placebo

Interventions

Vitamin CDIETARY_SUPPLEMENT

1 gram Vitamin C will be administrated orally, twice a day from 5 days before until 10 days after surgery.

Vitamin C
PlaceboOTHER

1 gram Placebo will be administrated orally, twice a day, from 5 days before until 10 days after surgery

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • patients who do not want to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AZ Maria Middelares

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

Related Publications (1)

  • Heerman J, Boydens C, Allaert S, Cathenis K, Deryckere K, Vanoverschelde H. Effect of Perioperative Oral Vitamin C Supplementation on In-Hospital Postoperative Medication Costs for Cardiac Surgery Patients: A Prospective, Single-Centre, Randomised Clinical Trial. Pharmacoecon Open. 2023 Jul;7(4):655-663. doi: 10.1007/s41669-023-00412-3. Epub 2023 Apr 11.

    PMID: 37039967DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Officials

  • Alain F Kalmar, MD, PhD, MSc

    Maria Middelares Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alain F Kalmar, MD,PhD,MSc

CONTACT

+32 246 17 00alain.kalmar@gmail.com

Nicky Van Der Vekens, DVM,PhD,MSc

CONTACT

+32 246 17 09nicky.vandervekens@azmmsj.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: One group receives Vitamin C, the other group received placebo.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Anesthesist

Study Record Dates

First Submitted

June 22, 2018

First Posted

July 19, 2018

Study Start

October 1, 2018

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

March 12, 2019

Record last verified: 2019-03

Locations

BE(1)