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

Primary Purpose

Atrial Fibrillation, Atrial Flutter

Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Oral
Intravenous drug
Sponsored by
Spectrum Health - Lakeland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Matthew Hysell

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Diltiazem with oral and intravenous treatment

traditional atrial fibrillation with rapid ventricular response

Arm 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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Rate of hypotension
rates of patients experiencing systolic blood pressure less than 90

Full Information

First Posted
September 23, 2021
Last Updated
October 25, 2022
Sponsor
Spectrum Health - Lakeland
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1. Study Identification

Unique Protocol Identification Number
NCT05391893
Brief Title
Effect of Oral and Intravenous Diltiazem Protocol for Emergency Department Atrial Fibrillation
Official Title
Emergency Department Atrial Fibrillation Oral Diltiazem Observation Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 19, 2020 (Actual)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spectrum Health - Lakeland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Atrial Flutter

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
A treatment protocol using oral and IV diltiazem has been implemented. We will compare admission rates, time to heart rate control, and hypotension between the protocol group and patients receiving traditional treatments for atrial fibrillation with rapid ventricular response
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diltiazem with oral and intravenous treatment
Arm Type
Active Comparator
Arm 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
Arm Title
traditional atrial fibrillation with rapid ventricular response
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Oral
Other Intervention Name(s)
these patients will receive oral and intravenous diltiazem
Intervention Description
Diltiazem 0.25mg/kg injection, give over 2 minutes, max dose 30mg
Intervention Type
Drug
Intervention Name(s)
Intravenous drug
Intervention Description
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 Outcome Measure Information:
Title
Admission rate
Description
This will compare rates of patients admitted between the protocol group and patients treated traditionally
Time Frame
1 days
Title
Time to heart rate less than 110
Description
This will compare the total hours from first medicine administration to heart rate less than 110 between the protocol and traditional treatment group
Time Frame
1 days
Secondary Outcome Measure Information:
Title
Rate of hypotension
Description
rates of patients experiencing systolic blood pressure less than 90
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Matthew Hysell
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States

12. IPD Sharing Statement

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

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