NCT01107730

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at below P25 for phase_3 atrial-fibrillation

Timeline
Completed

Started Apr 2010

Longer than P75 for phase_3 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 21, 2010

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
1 month until next milestone

Results Posted

Study results publicly available

May 13, 2015

Completed
Last Updated

October 19, 2015

Status Verified

September 1, 2015

Enrollment Period

5 years

First QC Date

April 20, 2010

Results QC Date

April 28, 2015

Last Update Submit

September 28, 2015

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillationCardiac valve repairAneurysm repairCABGOn-pumpCardiac surgeryVitamin C

Outcome Measures

Primary Outcomes (1)

  • 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.

    Within the first 30 days (plus or minus 3 days)

Study Arms (3)

L-Carnitine

ACTIVE COMPARATOR

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

Drug: L-Carnitine

Vitamin C

ACTIVE COMPARATOR

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

Drug: Vitamin C

Placebo

ACTIVE COMPARATOR
Drug: Placebo

Interventions

Vitamin CDRUG

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

Vitamin C
L-CarnitineDRUG

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

L-Carnitine
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age15 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing on-pump cardiac surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University General Hospital Attikon

Athens, 12462, Greece

Location

Related Publications (1)

  • Rodrigo R, Vinay J, Castillo R, Cereceda M, Asenjo R, Zamorano J, Araya J, Castillo-Koch R, Espinoza J, Larrain E. Use of vitamins C and E as a prophylactic therapy to prevent postoperative atrial fibrillation. Int J Cardiol. 2010 Feb 4;138(3):221-8. doi: 10.1016/j.ijcard.2009.04.043. Epub 2009 May 15.

    PMID: 19446899RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Ascorbic AcidCarnitine

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydratesTrimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAmines

Results Point of Contact

Title
Ioannis K. Toumpoulis
Organization
Attikon Hospital
toumpoul@otenet.gr
00306977243942

Study Officials

  • Ioannis Toumpoulis, MD

    University of Athens Medical School, Attikon Hospital, Cardiology Department

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 20, 2010

First Posted

April 21, 2010

Study Start

April 1, 2010

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

October 19, 2015

Results First Posted

May 13, 2015

Record last verified: 2015-09

Locations

GR(1)