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

• Sponsor: Attikon Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01107730
• Collaborator: (none)
• Enrollment: 33
• Location: 1
• Arms: 3
• Duration (Months): 60
• Patients Per Site Per Month: 0.6

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Drug: Vitamin C; Drug: L-Carnitine; Drug: Placebo	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 33 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• 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 Start Date: Apr 1, 2010
• Actual Primary Completion Date: Apr 1, 2015
• Actual Study Completion Date: Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: L-Carnitine L-Carnitine intravenously (2 gr/day [1grX2] for 2 days prior to surgery, and postoperatively for 4 days	Drug: L-Carnitine; L-Carnitine intravenously (2 gr/day [1grX2] for 2 days prior to surgery, and postoperatively for 4 days
Active Comparator: Vitamin C VitC intravenously (2g/day [500mgX4] for 2 days prior to surgery, and postoperatively for 4 days	Drug: Vitamin C; VitC intravenously (2g/day [500mgX4] for 2 days prior to surgery, and postoperatively for 4 days
Active Comparator: Placebo	Drug: Placebo; Placebo

Outcome Measures

Primary Outcome Measures

1. Incidence of Postoperative Atrial Fibrillation [Within 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University General Hospital Attikon	Athens		Greece	12462

Sponsors and Collaborators

• Attikon Hospital

Investigators

• Study Chair: Ioannis Toumpoulis, MD, University of Athens Medical School, Attikon Hospital, Cardiology Department

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Polymeropoulos Evangelos, Dr, Attikon Hospital
• ClinicalTrials.gov Identifier: NCT01107730
• Other Study ID Numbers: 268/27-07-09
• First Posted: Apr 21, 2010
• Last Update Posted: Oct 19, 2015
• Last Verified: Sep 1, 2015

• Keywords provided by Polymeropoulos Evangelos, Dr, Attikon Hospital: Atrial fibrillation; Cardiac valve repair; Aneurysm repair; CABG; On-pump; Cardiac surgery; Vitamin C
• Additional relevant MeSH terms: Atrial Fibrillation; Ascorbic Acid

Study Results

Participant Flow

Arm/Group Title	L-Carnitine	Vitamin C	Placebo
Arm/Group 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	Placebo: Placebo
Period Title: Overall Study
STARTED	11	11	11
COMPLETED	11	11	11
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	L-Carnitine	Vitamin C	Placebo	Total
Arm/Group Description	Carnitine 2 days preoperatively and 4 days postoperatively	Vitamin C 2 days preoperatively and 4 days postoperatively	Placebo: Placebo	Total of all reporting groups
Overall Participants	11	11	11	33
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	3 27.3%	6 54.5%	5 45.5%	14 42.4%
>=65 years	8 72.7%	5 45.5%	6 54.5%	19 57.6%
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	75	64	65	66
Sex: Female, Male (Count of Participants)
Female	4 36.4%	4 36.4%	5 45.5%	13 39.4%
Male	7 63.6%	7 63.6%	6 54.5%	20 60.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%
White	11 100%	11 100%	11 100%	33 100%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Greece	11 100%	11 100%	11 100%	33 100%

Outcome Measures

1. Primary Outcome

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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	L-Carnitine	Vitamin C	Placebo
Arm/Group Description	Carnitine 2 days preoperatively and 4 days postoperatively	Vitamin C 2 days preoperatively and 4 days postoperatively	Placebo: Placebo
Measure Participants	11	11	11
Number [participants]	5 45.5%	4 36.4%	5 45.5%

Adverse Events

Arm/Group Title	L-Carnitine		Vitamin C		Placebo
Arm/Group Description	Carnitine 2 days preoperatively and 4 days postoperatively Carnitine: Carnitine 2 days preoperatively and 4 days postoperatively		Vitamin C 2 days preoperatively and 4 days postoperatively Vitamin C: Vitamin C 2 days preoperatively and 4 days postoperatively		Placebo: Placebo
All Cause Mortality
	L-Carnitine		Vitamin C		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	L-Carnitine		Vitamin C		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/11 (0%)		0/11 (0%)
Other (Not Including Serious) Adverse Events
	L-Carnitine		Vitamin C		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/11 (0%)		0/11 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.