Influence of Vitamin C on Post-operative Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03592680
• Other study ID #: MMS.2017.011
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: June 2021

Study information

• Verified date: March 2019
• Source: Algemeen Ziekenhuis Maria Middelares
• Contact: Alain F Kalmar, MD,PhD,MSc
• Phone: +32 246 17 00
• Email: alain.kalmar[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• signed informed consent

• eligible for elective cardiac surgery

• preoperative sinus rhythm

Exclusion Criteria:

• patients who do not want to participate

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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

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

Locations

Country	Name	City	State
Belgium	AZ Maria Middelares	Gent	Oost-Vlaanderen

Sponsors (1)

Lead Sponsor	Collaborator
Algemeen Ziekenhuis Maria Middelares

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arrhythmia	Incidence	First 5 days postoperatively
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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
Secondary	subclinical kidney damage	change in Value of NGAL between pre-incision and post-CPB	after induction of anesthesia and two hours after CPB
Secondary	Postoperative complications	Number of unexpected complications requiring medical interventions	from time of arrival at ICU until the time of hospital discharge. upto 120 days