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Effect of Oral and Intravenous Diltiazem Protocol for Emergency Department Atrial Fibrillation

Sponsor
Spectrum Health - Lakeland (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05391893
Collaborator
(none)
200
Enrollment
1
Location
2
Arms
23.4
Anticipated Duration (Months)
8.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of the study is to reduce hospital admission and decrease time to disposition through establishing an effective treatment protocol for AF and Atrial Flutter in the Emergency Department of Spectrum Health Lakeland. Secondary outcome is to measure if oral diltiazem is an effective HR controlling agent in AF RVR and Flutter.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A treatment protocol using oral and IV diltiazem has been implemented. We will compare admission rates, time to heart rate control, and hypotension between the protocol group and patients receiving traditional treatments for atrial fibrillation with rapid ventricular responseA treatment protocol using oral and IV diltiazem has been implemented. We will compare admission rates, time to heart rate control, and hypotension between the protocol group and patients receiving traditional treatments for atrial fibrillation with rapid ventricular response
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Emergency Department Atrial Fibrillation Oral Diltiazem Observation Protocol
Actual Study Start Date :
Jun 19, 2020
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Diltiazem with oral and intravenous treatment

Diltiazem 0.25mg/kg injection, give over 2 minutes, max dose 30mg. 15 minutes following Diltiazem Infusion administer oral Diltiazem 60mg IR Tablet, do not give if BP<100

Drug: Oral
Diltiazem 0.25mg/kg injection, give over 2 minutes, max dose 30mg
Other Names:
  • these patients will receive oral and intravenous diltiazem

    		•
    Placebo Comparator: traditional atrial fibrillation with rapid ventricular response

    these patients will receive traditional treatments at provider discretion. To be included in teh study their initial heart rate must also be over 125, and they must receive at least one intravenous medication for atrial fibrillation with rapid ventricular response. This will be a heterogenous group of patients receiving digoxin, amiodarone, various beta-blockers, and intravenous diltiazem without oral diltiazem.

    Drug: Intravenous drug
    these patients will receive traditional treatments at provider discretion. They must receive at least one intravenous medication for atrial fibrillation with rapid ventricular response. This will be a heterogenous group of patients receiving digoxin, amiodarone, various beta-blockers, and intravenous diltiazem without oral diltiazem.

    Outcome Measures

    Primary Outcome Measures

    1. Admission rate [1 days]

      This will compare rates of patients admitted between the protocol group and patients treated traditionally

    2. Time to heart rate less than 110 [1 days]

      This will compare the total hours from first medicine administration to heart rate less than 110 between the protocol and traditional treatment group

    Secondary Outcome Measures

    1. Rate of hypotension [1 day]

      rates of patients experiencing systolic blood pressure less than 90

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Heart rate >125

    • Systolic BP>110

    • Atrial Fibrillation/Flutter confirmed on ECG.

    • Meets observation unit requirements (performs certain ADL's (acts of daily living)

    • Age>18.

    Exclusion Criteria:

    • Wolf-Parkinson-White syndrome

    • ST Elevation Myocardial Infarction

    • Pregnant

    • Clinical diagnosis of Sepsis,

    • Decompensated HF

    • allergy to Diltiazem

    • provider discretion

    • clinical need for cardioversion

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Matthew Hysell Saint Joseph Michigan United States 49085

    Sponsors and Collaborators

    • Spectrum Health - Lakeland

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Spectrum Health - Lakeland
    ClinicalTrials.gov Identifier:
    NCT05391893
    Other Study ID Numbers:
    • EGME#03-2021
    First Posted:
    May 26, 2022
    Last Update Posted:
    May 26, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Atrial Fibrillation
    Atrial Flutter
    Emergencies
    Diltiazem

    Study Results

    No Results Posted as of May 26, 2022