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

October 27, 2023 updated by: Spectrum Health - Lakeland

Emergency Department Atrial Fibrillation Oral Diltiazem Observation Protocol

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

444

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Saint Joseph, Michigan, United States, 49085
        • Matthew Hysell

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Admission rate
Time Frame: 1 days
This will compare rates of patients admitted between the protocol group and patients treated traditionally
1 days
Time to heart rate less than 110
Time Frame: 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
1 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of hypotension
Time Frame: 1 day
rates of patients experiencing systolic blood pressure less than 90
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spectrum Health - Lakeland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2020

Primary Completion (Actual)

April 1, 2023

Study Completion (Actual)

April 1, 2023

Study Registration Dates

First Submitted

September 23, 2021

First Submitted That Met QC Criteria

May 21, 2022

First Posted (Actual)

May 26, 2022

Study Record Updates

Last Update Posted (Actual)

October 31, 2023

Last Update Submitted That Met QC Criteria

October 27, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EGME#03-2021

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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