Atrial Fibrillation, Atrial Flutter
Conditions
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.
Interventions
DRUGOral
Diltiazem 0.25mg/kg injection, give over 2 minutes, max dose 30mg
DRUGIntravenous 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.
Sponsors
Corewell Health South
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Rate of Hypotension | 1 day | rates of patients experiencing systolic blood pressure less than 90 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Diltiazem With Oral and Intravenous Treatment 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
Oral: Diltiazem 0.25mg/kg injection, give over 2 minutes, max dose 30mg | 177 |
| Traditional Atrial Fibrillation With Rapid Ventricular Response 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.
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. | 267 |
| Total | 444 |
Baseline characteristics
| Characteristic | Diltiazem With Oral and Intravenous Treatment | Total | Traditional Atrial Fibrillation With Rapid Ventricular Response |
|---|---|---|---|
| Age, Continuous | 69.1 years STANDARD_DEVIATION 13.3 | 70.05 years STANDARD_DEVIATION 13 | 71 years STANDARD_DEVIATION 12.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants | 57 Participants | 37 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 157 Participants | 387 Participants | 230 Participants |
| Region of Enrollment United States | 177 participants | 444 participants | 267 participants |
| Sex: Female, Male Female | 102 Participants | 240 Participants | 138 Participants |
| Sex: Female, Male Male | 75 Participants | 204 Participants | 129 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 177 | 1 / 267 |
| other Total, other adverse events | 7 / 177 | 17 / 267 |
| serious Total, serious adverse events | 0 / 177 | 0 / 267 |
Outcome results
Primary
Admission Rate
This will compare rates of patients admitted between the protocol group and patients treated traditionally
Time frame: 1 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Diltiazem With Oral and Intravenous Treatment | Admission Rate | 98 Participants |
| Traditional Atrial Fibrillation With Rapid Ventricular Response | Admission Rate | 188 Participants |
Primary
Treatment Success at 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
Time frame: 3 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Diltiazem With Oral and Intravenous Treatment | Treatment Success at 3 Hours | 150 Participants |
| Traditional Atrial Fibrillation With Rapid Ventricular Response | Treatment Success at 3 Hours | 192 Participants |
Secondary
Rate of Hypotension
rates of patients experiencing systolic blood pressure less than 90
Time frame: 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Diltiazem With Oral and Intravenous Treatment | Rate of Hypotension | 7 Participants |
| Traditional Atrial Fibrillation With Rapid Ventricular Response | Rate of Hypotension | 17 Participants |