Controlling Rapid Atrial Fibrillation With Dexmedetomidine

NCT04042727 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: IRB2019-00250
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Rapid Atrial Fibrillation; Heart Rate Control

Keywords

Dexmedetomidine; Critical Care; Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Mean Systolic Blood Pressure

  Assess mean systolic blood pressure measurements between the two arms

  During Study Drug Infusion Period

Study Arms (2)

Dexmedetomidine plus Standard of Care

EXPERIMENTAL

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.

Drug: Dexmedetomidine Hydrochloride

Placebo plus Standard of Care

PLACEBO COMPARATOR

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.

Other: Normal Saline

Interventions

Dexmedetomidine Hydrochloride 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.

Also known as: Precedex

Dexmedetomidine plus Standard of Care

Normal Saline 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.

Also known as: Sodium Chloride Injection

Placebo plus Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stony Brook University: lead

Study Sites (1)

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Dexmedetomidine; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Andreas KAlogeropoulos
• Organization: Stony Brook University

Andreas.Kalogeropoulos@stonybrookmedicine.edu

4045124463

Study Officials

• Andreas Kalogeropoulos, MD MPH PhD

  Stony Brook University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Cardiovascular Research

Model Details: Eligible patients will be randomized to receive either Dexmedetomidine or Placebo in addition to Standard of Care. Investigational pharmacy will be primarily responsible for randomization.

Study Record Dates

• First Submitted: July 31, 2019
• First Posted: August 2, 2019
• Study Start: August 21, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: June 4, 2024
• Results First Posted: June 4, 2024

Record last verified: 2024-06

Locations

US (1)