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Controlling Rapid Atrial Fibrillation With Dexmedetomidine

NCT04042727 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2024-06-04

Study results available
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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.

Conditions

  • Rapid Atrial Fibrillation
  • Heart Rate Control

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Andreas Kalogeropoulos, MD MPH PhD · Stony Brook University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-21
Primary Completion
2021-12-31
Completion
2021-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04042727 on ClinicalTrials.gov