Controlling Rapid Atrial Fibrillation With Dexmedetomidine

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Controlling Rapid Atrial Fibrillation With Dexmedetomidine (C-RAD) Trial

Conditions
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Rapid Atrial Fibrillation, Heart Rate Control

Intervention / Treatment
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* Drug: Dexmedetomidine Hydrochloride
* Other: Normal Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Eligible patients will be randomized to receive either Dexmedetomidine or Placebo in addition to Standard of Care. Investigational pharmacy will be primarily responsible for randomization.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine plus Standard of Care<br>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. | Drug: Dexmedetomidine Hydrochloride<br>* Six vials of Dexmedetomidine hydrochloride 100mcg/ml (2ml per vial) will be added to a 250mL bag of normal saline by the investigational pharmacy to prepare for infusion by patient's bedside nurse. Infusion rate will be 1mcg/kg/hr.<br>* Other names: Precedex;|
| Placebo Comparator: Placebo plus Standard of Care<br>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. | Other: Normal Saline<br>* 0.5% sodium chloride (NaCl). The investigational pharmacy will prepare the normal saline placebo 250mL bag for infusion by patient's bedside nurse. Infusion will be 1mcg/kg/hr.<br>* Other names: Sodium Chloride Injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Ventricular Heart Rate | Compare degree of heart rate control between study and placebo arm | Last 4 Hours of Study Drug Infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Rhythm Strips with Heart Rate <100 bpm | Compare rates of rate control between arms | Last 4 Hours of Study Drug Infusion | 
| Rhythm Conversion | Compare number of patients converting to sinus rhythm in each arm | Last 4 Hours of Study Drug Infusion | 
| Time to Heart Rate Control | Compare the time to achieve an average Heart Rate <100 bpm between the two arms | During Study Drug Infusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexmedetomidine, Critical Care, Atrial Fibrillation