Clinical trial

Emergency Department Atrial Fibrillation Oral Diltiazem Observation Protocol

Name

EGME#03-2021

Description

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.

Trial arms

Trial start

2020-06-19

Estimated PCD

2023-04-01

Trial end

2023-04-01

Status

Completed

Phase

Early phase I

Treatment

Oral

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

Arms:

Diltiazem with oral and intravenous treatment

Other names:

these patients will receive oral and intravenous diltiazem

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.

Arms:

traditional atrial fibrillation with rapid ventricular response

Size

444

Primary endpoint

Admission rate

1 days

Time to heart rate less than 110

1 days

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 444, 'type': 'ACTUAL'}}

Updated at

2023-10-31

1 organization

2 products

2 indications

Organization

Spectrum Health Lakeland

Product

Indication

Indication

Product