Heart Rate Control, Rapid Atrial Fibrillation
Conditions
Keywords
Dexmedetomidine, Critical Care, Atrial Fibrillation
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.
Interventions
DRUGDexmedetomidine 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.
OTHERNormal 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.
Sponsors
Stony Brook University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Systolic Blood Pressure | During Study Drug Infusion Period | Assess mean systolic blood pressure measurements between the two arms |
Countries
United States
Participant flow
Recruitment details
Recruitment has stopped because of challenges associated with the COVID-19 pandemic
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 6 |
| 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.
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. | 7 |
| Total | 13 |
Baseline characteristics
| Characteristic | Placebo Plus Standard of Care | Total | Dexmedetomidine Plus Standard of Care |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 10 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 3 Participants | 2 Participants |
| Age, Continuous | 72.3 years STANDARD_DEVIATION 5.15 | 70.9 years STANDARD_DEVIATION 13.1 | 69.3 years STANDARD_DEVIATION 19.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 10 Participants | 4 Participants |
| Region of Enrollment United States | 7 participants | 13 participants | 6 participants |
| Sex: Female, Male Female | 3 Participants | 5 Participants | 2 Participants |
| Sex: Female, Male Male | 4 Participants | 8 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 7 |
| other Total, other adverse events | 0 / 6 | 0 / 7 |
| serious Total, serious adverse events | 0 / 6 | 0 / 7 |
Outcome results
Primary
Mean Systolic Blood Pressure
Assess mean systolic blood pressure measurements between the two arms
Time frame: During Study Drug Infusion Period
Population: Data not collected because of protocol termination