Pilot Study of the Safety and Efficacy of Intravenous Vitamin C in Patients Undergoing Atrial Fibrillation Ablation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Plasma Levels of Ascorbic Acid
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Vitamin C
干预措施: Vitamin C (Drug)
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Change in Plasma Levels of Ascorbic Acid
时间窗: baseline to 24 hours
Change in plasma levels of ascorbic acid
Change in Interleukin (IL-6)
时间窗: baseline to 30 days
Biomarker of inflammation
Change in hsCRP
时间窗: baseline to 30 days
Biomarker of inflammation
Change in Creatinine Levels
时间窗: Baseline to 30 days
Change in kidney function
Change in Plasma Ascorbic Acid Level
时间窗: Baseline to 30 days
Change in plasma ascorbic acid level
Change in Von Willebrand Factor (vWF)
时间窗: baseline to 30 days
Biomarker of blood vessel damage
次要结局
- Post Procedural Pain(baseline to 24 hours)