Controlling Rapid Atrial Fibrillation With Dexmedetomidine (C-RAD) Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Mean Systolic Blood Pressure
研究概览
简要总结
The purpose of this study is to assess the effects of Dexmedetomidine (DEX), on heart rate control in patients with rapid atrial fibrillation (AF) through a pragmatic, randomized, double blinded study comparing the addition of Dex or placebo to standard of care (SOC) treatment.
详细描述
Dexmedetomidine is a commonly used sedative/anxiolytic agent in the ICU with sympatholytic properties that can cause a decrease in heart rate. Eligible patients will be randomized into one of two groups: SOC plus Dex arm or SOC plus placebo (normal saline) arm. Study drug infusion will be administered at an infusion rate of 1μg/kg/hr via IV, and will not include a loading dose. Four 6-second telemetry rhythm strips will be collected per hour, starting one hour prior to study drug infusion, during the eight hour infusion period, and two hours post infusion cessation). Degree of heart rate control and time to heart rate control for both groups will be analyzed.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients in a SBU Hospital ICU with rapid-AF (with ventricular rates >100 bpm).
- •Patient screening will be conducted prior to patient or LAR consent.
排除标准
- •Patients age <18yrs;
- •Anticipated ICU stay <11hrs;
- •Permanently paced heart rhythm;
- •Known 2nd or 3rd degree heart block;
- •Junctional rhythms;
- •Known pregnancy;
- •Known allergy to Dexmedetomidine;
- •Receiving Dexmedetomidine prior to study onset;
- •Non-intubated patients w/ Glasgow Coma Scale <8;
- •Weight >400lbs (protocol dosing restriction);
- •Untreated, symptomatic hypotension (SBP<90mmHg);
- •Received amiodarone, lidocaine, or mexiletine w/in 4hrs prior to consent.
研究组 & 干预措施
Dexmedetomidine plus Standard of Care
Dexmedetomidine hydrochloride infusion will be prepared by the investigational pharmacy and administered intravenously at a rate of 1mcg/kg/hr for a duration of 8 hrs to patients in rapid Afib in addition to the usual standard of care as deemed necessary by patient's ICU team.
干预措施: Dexmedetomidine Hydrochloride (Drug)
Placebo plus Standard of Care
Normal Saline solution will be prepared by investigational pharmacy and administered intravenously at a rate of 1mcg/kg/hr for a duration of 8 hrs to patients in rapid Afib in addition to the usual standard of care as deemed necessary by patient's ICU team.
干预措施: Normal Saline (Other)
结局指标
主要结局
Mean Systolic Blood Pressure
时间窗: During Study Drug Infusion Period
Assess mean systolic blood pressure measurements between the two arms
次要结局
未报告次要终点
研究者
Andreas Kalogeropoulos
Director, Cardiovascular Research
Stony Brook University