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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin C | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin C | Drug | 200mg/kg/day split into 4 doses infused every six hours over 30 minutes in 50ml D5W |
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jayanthe Koneru, MD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32013700 | Derived | Trankle CR, Puckett L, Swift-Scanlan T, DeWilde C, Priday A, Sculthorpe R, Ellenbogen KA, Fowler A, Koneru JN. Vitamin C Intravenous Treatment In the Setting of Atrial Fibrillation Ablation: Results From the Randomized, Double-Blinded, Placebo-Controlled CITRIS-AF Pilot Study. J Am Heart Assoc. 2020 Feb 4;9(3):e014213. doi: 10.1161/JAHA.119.014213. Epub 2020 Jan 30. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vitamin C | Vitamin C: 200mg/kg/day split into 4 doses infused every six hours over 30 minutes in 50ml D5W |
| FG001 | Placebo | Placebo: 50mL infused over 30 minutes |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vitamin C | Vitamin C: 200mg/kg/day split into 4 doses infused every six hours over 30 minutes in 50ml D5W |
| BG001 | Placebo | Placebo: 50mL infused over 30 minutes |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Creatinine Levels | Change in Kidney Function | Posted | Median | Inter-Quartile Range | mg/dL | Baseline to 24 hours |
|
|
90 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vitamin C | Vitamin C: 200mg/kg/day split into 4 doses infused every six hours over 30 minutes in 50ml D5W |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pericarditis | Cardiac disorders | Systematic Assessment | Pericarditis within 24 hours of the ablation. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cory Trankle, MD | Virginia Commonwealth University | 804-213-2679 | cory.trankle@vcuhealth.org |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 23, 2018 | Mar 28, 2019 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Placebo | Other | 50mL infused over 30 minutes |
|
|
Biomarker of inflammation
| baseline to 30 days |
| Change in Von Willebrand Factor (vWF) | Biomarker of blood vessel damage | baseline to 30 days |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Change in Plasma Levels of Ascorbic Acid | Change in plasma levels of ascorbic acid | Posted | Median | Inter-Quartile Range | micromolar | baseline to 24 hours |
|
|
|
| Primary | Change in hsCRP | Biomarker of inflammation | Posted | Median | Inter-Quartile Range | mg/L | baseline to 24 hours |
|
|
|
| Primary | Change in Interleukin (IL-6) | Biomarker of inflammation | Posted | Median | Inter-Quartile Range | pg/mL | baseline to 24 hours |
|
|
|
| Primary | Change in Von Willebrand Factor (vWF) | Biomarker of blood vessel damage | Posted | Median | Inter-Quartile Range | micrograms/mL | baseline to 24 hours |
|
|
|
| Primary | Change in Creatinine Levels | Change in kidney function | Posted | Median | Inter-Quartile Range | mg/dL | Baseline to 30 days |
|
|
|
| Primary | Change in Plasma Ascorbic Acid Level | Change in plasma ascorbic acid level | Posted | Median | Inter-Quartile Range | micromolar | Baseline to 30 days |
|
|
|
| Primary | Change in hsCRP | Biomarker of inflammation | Posted | Median | Inter-Quartile Range | mg/L | baseline to 30 days |
|
|
|
| Primary | Change in Interleukin (IL-6) | Biomarker of inflammation | Posted | Median | Inter-Quartile Range | pg/mL | baseline to 30 days |
|
|
|
| Primary | Change in Von Willebrand Factor (vWF) | Biomarker of blood vessel damage | Posted | Median | Inter-Quartile Range | micrograms/mL | baseline to 30 days |
|
|
|
| Secondary | 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) | Posted | Median | Inter-Quartile Range | score on a scale | baseline to 24 hours |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 1 |
| 10 |
| EG001 | Placebo | Placebo: 50mL infused over 30 minutes | 0 | 10 | 0 | 10 | 1 | 10 |
|
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| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |