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

Phase 4

Completed

• Conditions: Atrial Fibrillation; Atrial Flutter
• Interventions: Drug: Intravenous drug; Drug: Oral

• Registration Number: NCT05391893
• Lead Sponsor: Spectrum Health - Lakeland

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-19
• Study First Submitted: 2021-09-23
• Study First Submitted QC: 2022-05-21
• Study First Posted: 2022-05-26
• Primary Completion: 2023-04-01
• Study Completion: 2023-04-01
• Status Verified: 2023-10
• Results First Submitted: 2024-12-03
• Results First Submitted QC: 2024-12-03
• Last Update Submitted: 2024-12-03
• Results First Posted: 2024-12-27
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 444

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
traditional atrial fibrillation with rapid ventricular response	Intravenous drug	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.
Diltiazem with oral and intravenous treatment	Oral	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

Primary Outcome Measures

Name	Time	Method
Admission Rate	1 days	This will compare rates of patients admitted between the protocol group and patients treated traditionally
Treatment Success at 3 Hours	3 hours	This will compare the total number of patients who in 3 hours from first medicine administration achieved heart rate less than 110 between the protocol and traditional treatment group

Secondary Outcome Measures

Name	Time	Method
Rate of Hypotension	1 day	rates of patients experiencing systolic blood pressure less than 90

Trial Locations

Locations (1)

Matthew Hysell; 🇺🇸 Saint Joseph, Michigan, United States