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

Spectrum Health - Lakeland

Status and phase: Completed; Phase 4

Conditions: Atrial Flutter; Atrial Fibrillation

Treatments: Drug: Intravenous drug; Drug: Oral

Study type: Interventional

Funder types: Other

Identifiers

NCT05391893

EGME#03-2021

Details and patient eligibility

About

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.

Enrollment: 444 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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444 participants in 2 patient groups, including a placebo group

Diltiazem with oral and intravenous treatment

Active Comparator group

Description:

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

Treatment:

Drug: Oral

traditional atrial fibrillation with rapid ventricular response

Placebo Comparator group

Description:

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.

Treatment:

Drug: Intravenous drug