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

NCT ID: NCT05391893

Last Updated: 2024-12-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

444 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-19

Study Completion Date

2023-04-01

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation Atrial Flutter

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 response
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Oral

Intervention Type DRUG

Diltiazem 0.25mg/kg injection, give over 2 minutes, max dose 30mg

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.

Group Type PLACEBO_COMPARATOR

Intravenous drug

Intervention Type 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.

Interventions

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Oral

Diltiazem 0.25mg/kg injection, give over 2 minutes, max dose 30mg

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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these patients will receive oral and intravenous diltiazem

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Spectrum Health - Lakeland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Matthew Hysell

Saint Joseph, Michigan, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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EGME#03-2021

Identifier Type: -

Identifier Source: org_study_id