Controlling Rapid Atrial Fibrillation With Dexmedetomidine (C-RAD)

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

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.

Study Overview

• Status: Terminated
• Conditions: Rapid Atrial Fibrillation; Heart Rate Control
• Intervention / Treatment: Drug: Dexmedetomidine Hydrochloride; Other: Normal Saline

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • Stony Brook, New York, United States, 11794
      • Stony Brook University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Dexmedetomidine Hydrochloride; 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.; Other Names: Precedex
Placebo Comparator: 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.	Other: Normal Saline; 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.; Other Names: Sodium Chloride Injection

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparative need for rate control medications	Comparative Assessment of Rate Control Medications Administered Between Both Arms	During Study Drug Infusion Period
Mean systolic blood pressure	Assess mean systolic blood pressure measurements between the two arms	During Study Drug Infusion Period
Need for vasopressors used in both arms	Comparative assessment of vasopressors used in both arms	Study drug infusion period

Collaborators and Investigators

• Sponsor: Stony Brook University
• Investigators: Principal Investigator: Andreas Kalogeropoulos, MD MPH PhD, Stony Brook University

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2019
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: July 31, 2019
• First Submitted That Met QC Criteria: July 31, 2019
• First Posted (Actual): August 2, 2019

Study Record Updates

• Last Update Posted (Actual): April 29, 2022
• Last Update Submitted That Met QC Criteria: April 22, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Dexmedetomidine; Critical Care
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: IRB2019-00250

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes