Influence of Vitamin C on Post-operative Atrial Fibrillation
NCT ID: NCT03592680
Last Updated: 2019-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
600 participants
INTERVENTIONAL
2018-10-01
2021-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Vitamin C
Vitamin C 1000mg PO from 5 days before surgery until 10 days after surgery
Vitamin C
1 gram Vitamin C will be administrated orally, twice a day from 5 days before until 10 days after surgery.
Placebo
Placebo as an alternative for Vitamin C tablets
Placebo
1 gram Placebo will be administrated orally, twice a day, from 5 days before until 10 days after surgery
Interventions
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Vitamin C
1 gram Vitamin C will be administrated orally, twice a day from 5 days before until 10 days after surgery.
Placebo
1 gram Placebo will be administrated orally, twice a day, from 5 days before until 10 days after surgery
Eligibility Criteria
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Inclusion Criteria
* eligible for elective cardiac surgery
* preoperative sinus rhythm
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Algemeen Ziekenhuis Maria Middelares
OTHER
Responsible Party
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Dr. Alain Kalmar, MD, PhD
Staff Anesthesist
Principal Investigators
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Alain F Kalmar, MD, PhD, MSc
Role: PRINCIPAL_INVESTIGATOR
Maria Middelares Hospital
Locations
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AZ Maria Middelares
Ghent, Oost-Vlaanderen, Belgium
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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MMS.2017.011
Identifier Type: -
Identifier Source: org_study_id
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