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

Atrial Fibrillation Clinical Trial

Official title:

Emergency Department Atrial Fibrillation Oral Diltiazem Observation Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05391893
• Other study ID #: EGME#03-2021
• Status: Completed
• Phase: Phase 4
• Start date: June 19, 2020
• Est. completion date: April 1, 2023

Study information

• Verified date: October 2023
• Source: Spectrum Health - Lakeland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 444
• Est. completion date: April 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Flutter
• Emergencies

Intervention

Drug:
• Oral
Diltiazem 0.25mg/kg injection, give over 2 minutes, max dose 30mg
• 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.

Locations

Country	Name	City	State
United States	Matthew Hysell	Saint Joseph	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Spectrum Health - Lakeland

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Admission rate	This will compare rates of patients admitted between the protocol group and patients treated traditionally	1 days
Primary	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	Rate of hypotension	rates of patients experiencing systolic blood pressure less than 90	1 day