Controlling Rapid Atrial Fibrillation With Dexmedetomidine

NCT ID: NCT04042727

Last Updated: 2024-06-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-21
• Study Completion Date: 2021-12-31

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.

Conditions

Rapid Atrial Fibrillation; Heart Rate Control

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Dexmedetomidine Hydrochloride

Intervention Type: DRUG

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.

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.

Group Type: PLACEBO_COMPARATOR

Normal Saline

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: OTHER

Other Intervention Names

Precedex; Sodium Chloride Injection

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stony Brook University

OTHER

Sponsor Role: lead

Responsible Party

Andreas Kalogeropoulos

Director, Cardiovascular Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andreas Kalogeropoulos, MD MPH PhD

Role: PRINCIPAL_INVESTIGATOR

Stony Brook University

Locations

Stony Brook University Hospital

Stony Brook, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB2019-00250

Identifier Type: -

Identifier Source: org_study_id