Back to resultsControlling Rapid Atrial Fibrillation With Dexmedetomidine (C-RAD)
Primary Purpose
Rapid Atrial Fibrillation, Heart Rate Control
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dexmedetomidine Hydrochloride
Normal Saline
Sponsored by
About this trial
This is an interventional treatment trial for Rapid Atrial Fibrillation focused on measuring Dexmedetomidine, Critical Care, Atrial Fibrillation
Eligibility Criteria
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.
Sites / Locations
- Stony Brook University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Dexmedetomidine plus Standard of Care
Placebo plus Standard of Care
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Mean Ventricular Heart Rate
Compare degree of heart rate control between study and placebo arm
Secondary Outcome Measures
Percentage of Rhythm Strips with Heart Rate <100 bpm
Compare rates of rate control between arms
Rhythm Conversion
Compare number of patients converting to sinus rhythm in each arm
Time to Heart Rate Control
Compare the time to achieve an average Heart Rate <100 bpm between the two arms
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04042727
Brief Title
Controlling Rapid Atrial Fibrillation With Dexmedetomidine
Acronym
C-RAD
Official Title
Controlling Rapid Atrial Fibrillation With Dexmedetomidine (C-RAD) Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Terminated
Why Stopped
Futility, as a result of CIVID-19 impact
Study Start Date
August 21, 2019 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stony Brook University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rapid Atrial Fibrillation, Heart Rate Control
Keywords
Dexmedetomidine, Critical Care, Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dexmedetomidine plus Standard of Care
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo plus Standard of Care
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine Hydrochloride
Other Intervention Name(s)
Precedex
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Normal Saline
Other Intervention Name(s)
Sodium Chloride Injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean Ventricular Heart Rate
Description
Compare degree of heart rate control between study and placebo arm
Time Frame
Last 4 Hours of Study Drug Infusion
Secondary Outcome Measure Information:
Title
Percentage of Rhythm Strips with Heart Rate <100 bpm
Description
Compare rates of rate control between arms
Time Frame
Last 4 Hours of Study Drug Infusion
Title
Rhythm Conversion
Description
Compare number of patients converting to sinus rhythm in each arm
Time Frame
Last 4 Hours of Study Drug Infusion
Title
Time to Heart Rate Control
Description
Compare the time to achieve an average Heart Rate <100 bpm between the two arms
Time Frame
During Study Drug Infusion
Other Pre-specified Outcome Measures:
Title
Comparative need for rate control medications
Description
Comparative Assessment of Rate Control Medications Administered Between Both Arms
Time Frame
During Study Drug Infusion Period
Title
Mean systolic blood pressure
Description
Assess mean systolic blood pressure measurements between the two arms
Time Frame
During Study Drug Infusion Period
Title
Need for vasopressors used in both arms
Description
Comparative assessment of vasopressors used in both arms
Time Frame
Study drug infusion period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Kalogeropoulos, MD MPH PhD
Organizational Affiliation
Stony Brook University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stony Brook University Hospital
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
12. IPD Sharing Statement
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Controlling Rapid Atrial Fibrillation With Dexmedetomidine
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