Influence of Vitamin C on Post-operative Atrial Fibrillation
Primary Purpose
Atrial Fibrillation
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Vitamin C
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation focused on measuring Post-operative atrial fibrillation, Ascorbic Acid, Vitamin C, antioxidant, Cardiac surgery
Eligibility Criteria
Inclusion Criteria:
- signed informed consent
- eligible for elective cardiac surgery
- preoperative sinus rhythm
Exclusion Criteria:
- patients who do not want to participate
Sites / Locations
- AZ Maria MiddelaresRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Vitamin C
Placebo
Arm Description
Vitamin C 1000mg PO from 5 days before surgery until 10 days after surgery
Placebo as an alternative for Vitamin C tablets
Outcomes
Primary Outcome Measures
Arrhythmia
Incidence
Secondary Outcome Measures
hours of endotracheal ventilation
number of hours of endotracheal ventilation after surgery
Length of stay at ICU
number of hours in the Intensive Care Unit
Length of stay in the hospital
number of hours in the hospital
Cost of postoperative medication
Total cost (€) of postoperative medication
subclinical kidney damage
change in Value of NGAL between pre-incision and post-CPB
Postoperative complications
Number of unexpected complications requiring medical interventions
Full Information
NCT ID
NCT03592680
First Posted
June 22, 2018
Last Updated
March 11, 2019
Sponsor
Algemeen Ziekenhuis Maria Middelares
1. Study Identification
Unique Protocol Identification Number
NCT03592680
Brief Title
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
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Algemeen Ziekenhuis Maria Middelares
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Post-operative atrial fibrillation, Ascorbic Acid, Vitamin C, antioxidant, Cardiac surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
One group receives Vitamin C, the other group received placebo.
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vitamin C
Arm Type
Active Comparator
Arm Description
Vitamin C 1000mg PO from 5 days before surgery until 10 days after surgery
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo as an alternative for Vitamin C tablets
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin C
Intervention Description
1 gram Vitamin C will be administrated orally, twice a day from 5 days before until 10 days after surgery.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
1 gram Placebo will be administrated orally, twice a day, from 5 days before until 10 days after surgery
Primary Outcome Measure Information:
Title
Arrhythmia
Description
Incidence
Time Frame
First 5 days postoperatively
Secondary Outcome Measure Information:
Title
hours of endotracheal ventilation
Description
number of hours of endotracheal ventilation after surgery
Time Frame
from arrival at ICU after surgery until the time of discharge from ICU. average 48 hours.
Title
Length of stay at ICU
Description
number of hours in the Intensive Care Unit
Time Frame
from time of arrival at ICU after surgery until the time of discharge from ICU. upto 14 days. average 48 hours.
Title
Length of stay in the hospital
Description
number of hours in the hospital
Time Frame
from time of arrival at ICU after surgery until the time of hospital discharge. upto 120 days.
Title
Cost of postoperative medication
Description
Total cost (€) of postoperative medication
Time Frame
from time of arrival at ICU after surgery until the time of hospital discharge. upto 120 days
Title
subclinical kidney damage
Description
change in Value of NGAL between pre-incision and post-CPB
Time Frame
after induction of anesthesia and two hours after CPB
Title
Postoperative complications
Description
Number of unexpected complications requiring medical interventions
Time Frame
from time of arrival at ICU until the time of hospital discharge. upto 120 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
signed informed consent
eligible for elective cardiac surgery
preoperative sinus rhythm
Exclusion Criteria:
patients who do not want to participate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alain F Kalmar, MD,PhD,MSc
Phone
+32 246 17 00
Email
alain.kalmar@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nicky Van Der Vekens, DVM,PhD,MSc
Phone
+32 246 17 09
Email
nicky.vandervekens@azmmsj.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alain F Kalmar, MD, PhD, MSc
Organizational Affiliation
Maria Middelares Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
AZ Maria Middelares
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathleen Stam
Email
kathleen.stam@azmmsj.be
First Name & Middle Initial & Last Name & Degree
Jan Heerman, MD, MSc
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Influence of Vitamin C on Post-operative Atrial Fibrillation
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