Vitamin C in Atrial Fibrillation Ablation

Study Overview
=================
Brief Summary
-----------------
Single-center, double-blinded, randomized, controlled safety and feasibility pilot study of high dose IV ascorbic acid (200mg/kg) over 24 hours, divided into four doses and administered every six hours with a 30 minute IV infusion time per dose, compared to matched placebo infusion

Official Title
-----------------
Pilot Study of the Safety and Efficacy of Intravenous Vitamin C in Patients Undergoing Atrial Fibrillation Ablation

Conditions
-----------------
Atrial Fibrillation Ablation

Intervention / Treatment
-----------------
* Drug: Vitamin C
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >/= 21 years Diagnosis of atrial fibrillation with plans for a catheter-based ablation procedure Ability to provide informed consent and willingness to be included in the study Exclusion Criteria: Known allergy to Vitamin C Inability to obtain informed consent Diabetes mellitus either requiring the use of insulin therapy or not requiring the use of insulin therapy but which is uncontrolled, defined as a glycosylated hemoglobin of greater than or equal to 8% Prior catheter-based ablation for atrial fibrillation Pregnancy or breast feeding Active renal calculus Active acute or chronic infection (including HIV or hepatitis C) Active or recent (within 5 years) malignancy Autoimmune or autoinflammatory disease Recent or active use of immunosuppressive medications Non-English speaking Ward of the state (inmate, other)

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vitamin C<br> | Drug: Vitamin C<br>* 200mg/kg/day split into 4 doses infused every six hours over 30 minutes in 50ml D5W<br>* Other names: Ascorbic Acid;|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* 50mL infused over 30 minutes<br>* Other names: D5W;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Creatinine Levels | Change in Kidney Function | Baseline to 24 hours | 
| Change in Plasma Levels of Ascorbic Acid | Change in plasma levels of ascorbic acid | baseline to 24 hours | 
| Change in hsCRP | Biomarker of inflammation | baseline to 24 hours | 
| Change in Interleukin (IL-6) | Biomarker of inflammation | baseline to 24 hours | 
| Change in Von Willebrand Factor (vWF) | Biomarker of blood vessel damage | baseline to 24 hours | 
| Change in Creatinine Levels | Change in kidney function | Baseline to 30 days | 
| Change in Plasma Ascorbic Acid Level | Change in plasma ascorbic acid level | Baseline to 30 days | 
| Change in hsCRP | Biomarker of inflammation | baseline to 30 days | 
| Change in Interleukin (IL-6) | Biomarker of inflammation | baseline to 30 days | 
| Change in Von Willebrand Factor (vWF) | Biomarker of blood vessel damage | baseline to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Procedural Pain | Sum of pain scores every six hours for the 24 hour period following ablation measured on a visual analog scale scored on a level from zero (no pain) to 10 (maximum pain) | baseline to 24 hours |