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Completed

NCT Number: NCT05391893

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Atrial Flutter Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Matthew Hysell

Saint Joseph, Michigan, 49085, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral

Drug

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

Other names: these patients will receive oral and intravenous diltiazem

Intravenous drug

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.

Primary outcomes

  1. Admission Rate

    Time frame: 1 days

    This will compare rates of patients admitted between the protocol group and patients treated traditionally

  2. Treatment Success at 3 Hours

    Time frame: 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 outcomes

  1. Rate of Hypotension

    Time frame: 1 day

    rates of patients experiencing systolic blood pressure less than 90

Sponsors and collaborators

Lead sponsor

Corewell Health South

Other

Registry information

Official study title

Emergency Department Atrial Fibrillation Oral Diltiazem Observation Protocol

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
May 26, 2022
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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