Clinical trial NCT03592680: Influence of Vitamin C on Post-operative Atrial Fibrillation
Official title: Influence of Oral Vitamine C Supplementation on the Incidence of Post-operative Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Post-operative atrial fibrillation
Ascorbic Acid
Vitamin C
antioxidant
Cardiac surgery
Lead sponsor: Algemeen Ziekenhuis Maria Middelares
Sponsor class: OTHER
First posted: 2018-07-19
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group receives Vitamin C, the other group received placebo.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* patients who do not want to participate

Primary outcomes:
measure: Arrhythmia
timeFrame: First 5 days postoperatively
Secondary outcomes:
measure: hours of endotracheal ventilation
timeFrame: from arrival at ICU after surgery until the time of discharge from ICU. average 48 hours.
measure: Length of stay at ICU
timeFrame: from time of arrival at ICU after surgery until the time of discharge from ICU. upto 14 days. average 48 hours.
measure: Length of stay in the hospital
timeFrame: from time of arrival at ICU after surgery until the time of hospital discharge. upto 120 days.
measure: Cost of postoperative medication
timeFrame: from time of arrival at ICU after surgery until the time of hospital discharge. upto 120 days
measure: subclinical kidney damage
timeFrame: after induction of anesthesia and two hours after CPB
measure: Postoperative complications
timeFrame: from time of arrival at ICU until the time of hospital discharge. upto 120 days
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: AZ Maria Middelares
state: Oost-Vlaanderen
Study officials:
affiliation: Maria Middelares Hospital
name: Alain F Kalmar, MD, PhD, MSc
role: PRINCIPAL_INVESTIGATOR
References: