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

Study Overview
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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.

Official Title
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Emergency Department Atrial Fibrillation Oral Diltiazem Observation Protocol

Conditions
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Atrial Fibrillation, Atrial Flutter

Intervention / Treatment
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* Drug: Oral
* Drug: Intravenous drug


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Diltiazem with oral and intravenous treatment<br>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<br>* Diltiazem 0.25mg/kg injection, give over 2 minutes, max dose 30mg<br>* Other names: these patients will receive oral and intravenous diltiazem;|
| Placebo Comparator: traditional atrial fibrillation with rapid ventricular response<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Admission rate | This will compare rates of patients admitted between the protocol group and patients treated traditionally | 1 days | 
| Time to heart rate less than 110 | 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 | rates of patients experiencing systolic blood pressure less than 90 | 1 day |