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

Primary Purpose

Atrial Fibrillation

Status

Completed

Phase

Phase 3

Locations

Greece

Study Type

Interventional

Intervention

Vitamin C

L-Carnitine

Placebo

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Cardiac valve repair, Aneurysm repair, CABG, On-pump, Cardiac surgery, Vitamin C

Eligibility Criteria

15 Years - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University General Hospital Attikon

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

L-Carnitine

Vitamin C

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01107730

First Posted

April 20, 2010

Last Updated

September 28, 2015

Sponsor

Attikon Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01107730

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Completed

Study Start Date

April 2010 (undefined)

Primary Completion Date

April 2015 (Actual)

Study Completion Date

April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Attikon Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

L-Carnitine

Arm Type

Active Comparator

Arm Description

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

Arm Title

Vitamin C

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Vitamin C

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

L-Carnitine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Incidence of Postoperative Atrial Fibrillation

Description

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ioannis Toumpoulis, MD

Organizational Affiliation

University of Athens Medical School, Attikon Hospital, Cardiology Department

Official's Role

Study Chair

Facility Information:

Facility Name

University General Hospital Attikon

City

Athens

ZIP/Postal Code

12462

Country

Greece

12. IPD Sharing Statement

Citations:

PubMed Identifier

19446899

Citation

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.

Results Reference

result

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

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