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Vitamin C for Prophylaxis of Post-operative Atrial Fibrillation in On-pump Cardiac Surgery Procedures

Randomized Double Blind Study of Administration of Vitamin C for Prophylaxis of Post-operative Atrial Fibrillation in On-pump Cardiac Surgery Procedures

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01107730
Enrollment
33
Registered
2010-04-21
Start date
2010-04-30
Completion date
2015-04-30
Last updated
2015-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation, Cardiac valve repair, Aneurysm repair, CABG, On-pump, Cardiac surgery, Vitamin C

Brief summary

The purpose of this study is to determine whether vitamin C is effective in the prophylaxis of post-operative atrial fibrillation in on-pump cardiac surgery

Detailed description

Atrial fibrillation (AF) is the single most common post-operative complication after on-pump cardiac surgery, ranging from roughly 25% in CABG procedures, up to 65% in valve replacement procedures. The presence of AF in cardiac surgery patients doubles the morbidity amongst these patients, as well as raising the mortality rates. VitC is an electron donor for a number of enzymatic systems, reducing potentially harmful free radicals. In post-procedural AF, there is increased peroxynitrite concentration, which is a target for vitamin C. A randomized, double blind study will be conducted in order to establish the efficiency of vitamin C as prophylaxis for postoperative AF.

Interventions

DRUGVitamin C

VitC intravenously (2g/day \[500mgX4\] for 2 days prior to surgery, and postoperatively for 4 days

DRUGL-Carnitine

L-Carnitine intravenously (2 gr/day \[1grX2\] for 2 days prior to surgery, and postoperatively for 4 days

DRUGPlacebo

Placebo

Sponsors

Attikon Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
15 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* Patients undergoing on-pump cardiac surgery

Exclusion criteria

* Off-pump cardiac surgery procedure * AF before the procedure * Recent infection and/or infectious endocarditis * Presence of neoplasia * Chronic renal failure with creatinine\>2.3 mg/dl * Hepatic failure * Autoimmune disease and/or disease that brings about a systematic inflammatory response * Thyroid disease * Systematic use of supplements that contain vitC or carnitine * The use of NSAIDs other than aspirin for a time period up to one month before the procedure

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Postoperative Atrial FibrillationWithin the first 30 days (plus or minus 3 days)The incidence of postoperative atrial fibrillation in cardiac surgery patients, using 2 different prophylaxis regimens with vitamin C, as compared to placebo.

Countries

Greece

Participant flow

Participants by arm

ArmCount
L-Carnitine
Carnitine 2 days preoperatively and 4 days postoperatively
11
Vitamin C
Vitamin C 2 days preoperatively and 4 days postoperatively
11
Placebo
Placebo: Placebo
11
Total33

Baseline characteristics

CharacteristicVitamin CPlaceboTotalL-Carnitine
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
5 Participants6 Participants19 Participants8 Participants
Age, Categorical
Between 18 and 65 years
6 Participants5 Participants14 Participants3 Participants
Age, Continuous64 years65 years66 years75 years
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
11 Participants11 Participants33 Participants11 Participants
Region of Enrollment
Greece
11 participants11 participants33 participants11 participants
Sex: Female, Male
Female
4 Participants5 Participants13 Participants4 Participants
Sex: Female, Male
Male
7 Participants6 Participants20 Participants7 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
0 / 110 / 110 / 11
serious
Total, serious adverse events
0 / 110 / 110 / 11

Outcome results

Primary

Incidence of Postoperative Atrial Fibrillation

The incidence of postoperative atrial fibrillation in cardiac surgery patients, using 2 different prophylaxis regimens with vitamin C, as compared to placebo.

Time frame: Within the first 30 days (plus or minus 3 days)

ArmMeasureValue (NUMBER)
L-CarnitineIncidence of Postoperative Atrial Fibrillation5 participants
Vitamin CIncidence of Postoperative Atrial Fibrillation4 participants
PlaceboIncidence of Postoperative Atrial Fibrillation5 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026