Controlling Rapid Atrial Fibrillation With Dexmedetomidine

Heart Rate Control Clinical Trial

— C-RAD  

Official title:

Controlling Rapid Atrial Fibrillation With Dexmedetomidine (C-RAD) Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04042727
• Other study ID #: IRB2019-00250
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: August 21, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: June 2024
• Source: Stony Brook University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Rate Control
• Rapid Atrial Fibrillation

Intervention

Drug:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
United States	Stony Brook University Hospital	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Stony Brook University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Systolic Blood Pressure	Assess mean systolic blood pressure measurements between the two arms	During Study Drug Infusion Period