Controlling Rapid Atrial Fibrillation With Dexmedetomidine

Phase 2

Terminated

• Conditions: Rapid Atrial Fibrillation; Heart Rate Control
• Interventions: Drug: Dexmedetomidine Hydrochloride; Other: Normal Saline

• Registration Number: NCT04042727
• Lead Sponsor: Stony Brook University

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.

Study Timeline

• Study First Submitted: 2019-07-31
• Study First Submitted QC: 2019-07-31
• Study First Posted: 2019-08-02
• Study Start: 2019-08-21
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Results First Submitted: 2024-04-10
• Status Verified: 2024-06
• Results First Submitted QC: 2024-06-01
• Last Update Submitted: 2024-06-01
• Results First Posted: 2024-06-04
• Last Update Posted: 2024-06-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine plus Standard of Care	Dexmedetomidine Hydrochloride	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.
Placebo plus Standard of Care	Normal Saline	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.

Primary Outcome Measures

Name	Time	Method
Mean Systolic Blood Pressure	During Study Drug Infusion Period	Assess mean systolic blood pressure measurements between the two arms

Trial Locations

Locations (1)

Stony Brook University Hospital; 🇺🇸 Stony Brook, New York, United States