Atrial FibrillationNCT03592680
Influence of Vitamin C on Post-operative Atrial Fibrillation
A study testing Vitamin C in people with Atrial Fibrillation, run by Algemeen Ziekenhuis Maria Middelares at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Vitamin C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2018to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- signed informed consent
- eligible for elective cardiac surgery
- preoperative sinus rhythm
Who cannot join
- patients who do not want to participate
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
AZ Maria Middelares
Ghent, Oost-Vlaanderen, 9000
Kathleen Stam, kathleen.stam@azmmsj.be
Jan Heerman, MD, MSc
About this study
Official title: Influence of Oral Vitamine C Supplementation on the Incidence of Post-operative Atrial Fibrillation
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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Vitamin C, Placebo
- Keywords
- Post-operative atrial fibrillation, Ascorbic Acid, Vitamin C, antioxidant, Cardiac surgery
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin CDietary supplement
1 gram Vitamin C will be administrated orally, twice a day from 5 days before until 10 days after surgery.
PlaceboOther
1 gram Placebo will be administrated orally, twice a day, from 5 days before until 10 days after surgery
| Study group | Role | What they receive |
|---|---|---|
| Vitamin C | Active comparator | Vitamin C 1000mg PO from 5 days before surgery until 10 days after surgery Receives: Dietary Supplement: Vitamin C |
| Placebo | Placebo comparator | Placebo as an alternative for Vitamin C tablets Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arrhythmia
Incidence
Measured: First 5 days postoperatively
Secondary outcomes (6)
hours of endotracheal ventilation
number of hours of endotracheal ventilation after surgery
Measured: from arrival at ICU after surgery until the time of discharge from ICU. average 48 hours.
Length of stay at ICU
number of hours in the Intensive Care Unit
Measured: 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
number of hours in the hospital
Measured: from time of arrival at ICU after surgery until the time of hospital discharge. upto 120 days.
Cost of postoperative medication
Total cost (€) of postoperative medication
Measured: from time of arrival at ICU after surgery until the time of hospital discharge. upto 120 days
subclinical kidney damage
change in Value of NGAL between pre-incision and post-CPB
Measured: after induction of anesthesia and two hours after CPB
Postoperative complications
Number of unexpected complications requiring medical interventions
Measured: from time of arrival at ICU until the time of hospital discharge. upto 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start1 Oct 2018
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One group receives Vitamin C, the other group received placebo.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Algemeen Ziekenhuis Maria Middelares
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Alain Kalmar, MD, PhD, Algemeen Ziekenhuis Maria Middelares
- Investigators
- Alain F Kalmar, MD, PhD, MSc, Principal investigator, Maria Middelares Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592680
- Sponsor's protocol ID
- MMS.2017.011
- Status last verified
- Mar 2019
- First submitted
- 22 Jun 2018
- Last updated
- 12 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37039967
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Oral Vitamine C Supplementation on the Incidence of Post-operative Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03592680
- Acronym / sponsor ID
- MMS.2017.011
- Conditions
- Atrial Fibrillation
- Keywords
- Post-operative atrial fibrillation, Ascorbic Acid, Vitamin C, antioxidant, Cardiac surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Algemeen Ziekenhuis Maria MiddelaresUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 19 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- One group receives Vitamin C, the other group received placebo.
| Arm | Type | Receives |
|---|---|---|
| Vitamin C | Active comparator | Dietary Supplement: Vitamin CVitamin C 1000mg PO from 5 days before surgery until 10 days after surgery |
| Placebo | Placebo comparator | Other: PlaceboPlacebo as an alternative for Vitamin C tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- signed informed consent
- eligible for elective cardiac surgery
- preoperative sinus rhythm
Key exclusion criteria (1 listed)
- patients who do not want to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin C1 gram Vitamin C will be administrated orally, twice a day from 5 days before until 10 days after surgery. | Dietary supplement | Vitamin C |
| Placebo1 gram Placebo will be administrated orally, twice a day, from 5 days before until 10 days after surgery | Other | Placebo |
Primary outcome
Arrhythmia
Time frame: First 5 days postoperatively
Incidence
6 secondary outcomes
hours of endotracheal ventilation
Time frame: from arrival at ICU after surgery until the time of discharge from ICU. average 48 hours.
Length of stay at ICU
Time frame: 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
Time frame: from time of arrival at ICU after surgery until the time of hospital discharge. upto 120 days.
Cost of postoperative medication
Time frame: from time of arrival at ICU after surgery until the time of hospital discharge. upto 120 days
subclinical kidney damage
Time frame: after induction of anesthesia and two hours after CPB
Postoperative complications
Time frame: from time of arrival at ICU until the time of hospital discharge. upto 120 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2019.
- Derived from this study: PubMed 37039967Heerman 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.
- Individual participant dataSharing planned: Undecided
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alain F Kalmar, MD, PhD, MSc principal investigator
Maria Middelares Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin C in people with Atrial Fibrillation, run by Algemeen Ziekenhuis Maria Middelares at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alain F Kalmar, MD,PhD,MSc (+32 246 17 00, alain.kalmar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arrhythmia (time frame: First 5 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03592680, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2019.