Controlling Rapid Atrial Fibrillation With Dexmedetomidine (C-RAD)

Stony Brook University

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Rapid Atrial Fibrillation; Heart Rate Control

Treatments: Other: Normal Saline; Drug: Dexmedetomidine Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT04042727

IRB2019-00250

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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13 participants in 2 patient groups, including a placebo group

Dexmedetomidine plus Standard of Care

Experimental group

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.

Treatment:

Drug: Dexmedetomidine Hydrochloride

Placebo plus Standard of Care

Placebo Comparator group

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.

Treatment:

Other: Normal Saline