Atrial Fibrillation
Conditions
Keywords
Post-operative atrial fibrillation, Ascorbic Acid, Vitamin C, antioxidant, Cardiac surgery
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.
Interventions
DIETARY_SUPPLEMENTVitamin C
1 gram Vitamin C will be administrated orally, twice a day from 5 days before until 10 days after surgery.
OTHERPlacebo
1 gram Placebo will be administrated orally, twice a day, from 5 days before until 10 days after surgery
Sponsors
Algemeen Ziekenhuis Maria Middelares
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
One group receives Vitamin C, the other group received placebo.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* signed informed consent * eligible for elective cardiac surgery * preoperative sinus rhythm
Exclusion criteria
* patients who do not want to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Arrhythmia | First 5 days postoperatively | Incidence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| hours of endotracheal ventilation | from arrival at ICU after surgery until the time of discharge from ICU. average 48 hours. | number of hours of endotracheal ventilation after surgery |
| 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. | number of hours in the Intensive Care Unit |
| Postoperative complications | from time of arrival at ICU until the time of hospital discharge. upto 120 days | Number of unexpected complications requiring medical interventions |
| Cost of postoperative medication | from time of arrival at ICU after surgery until the time of hospital discharge. upto 120 days | Total cost (€) of postoperative medication |
| subclinical kidney damage | after induction of anesthesia and two hours after CPB | change in Value of NGAL between pre-incision and post-CPB |
| Length of stay in the hospital | from time of arrival at ICU after surgery until the time of hospital discharge. upto 120 days. | number of hours in the hospital |
Countries
Belgium
Contacts
Primary ContactAlain F Kalmar, MD,PhD,MSc
Backup ContactNicky Van Der Vekens, DVM,PhD,MSc
Outcome results
None listed