Controlling Rapid Atrial Fibrillation With Dexmedetomidine

Last updated: June 1, 2024
Sponsor: Stony Brook University
Overall Status: Terminated

Phase

2/3

Condition

Chest Pain

Cardiac Disease

Arrhythmia

Treatment

Normal Saline

Dexmedetomidine Hydrochloride

Clinical Study ID

NCT04042727
IRB2019-00250
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients in a SBU Hospital ICU with rapid-AF (with ventricular rates >100bpm).

  • Patient screening will be conducted prior to patient or LAR consent.

Exclusion

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

Total Participants: 13
Treatment Group(s): 2
Primary Treatment: Normal Saline
Phase: 2/3
Study Start date:
August 21, 2019
Estimated Completion Date:
December 31, 2021

Study 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.

Connect with a study center

  • Stony Brook University Hospital

    Stony Brook, New York 11794
    United States

    Site Not Available

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