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

S

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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