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| ID | Type | Description | Link |
|---|---|---|---|
| 22.135 | Other Identifier | Advocate Aurora Health Care |
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The purpose of this study is to see how well calcium pre-treatment works for decreasing incidence of drug-induced hypotension after diltiazem administration for treatment of atrial flutter with rapid ventricular rate.
Non-dihydropyridine calcium channel blockers(CCB) are routinely used in the treatment of atrial fibrillation or flutter with rapid ventricular response (AFF with RVR); however, their use can be limited by drug-induced hypotension. This drug induced hypotension limits and complicates CCB use in the treatment of AFF with RVR. Calcium pre-treatment with calcium channel blocker administration has been studied extensively with verapamil administration in preventing drug induced hypotension however, similar studies evaluating calcium pretreatment with diltiazem administration in the prevention of drug-induced hypotension are limited.
The purpose of this study is to compare the relative efficacy and safety for calcium pretreatment with diltiazem in the treatment of AFF with RVR in preventing drug-induced hypotension. This prospective, randomized double-blinded study will evaluate patients who present to the emergency department at Advocate Christ Medical Center with a diagnosis of AFF with RVR with ventricular rate greater than or equal to 120 beats per minute from IRB approval to June 1, 2024. Via simple randomization, patients will be administered calcium pretreatment versus control prior to diltiazem administration. Calcium gluconate 1 gm or 100 mL of normal saline will be administered as an intravenous infusion over 5 minutes followed by bolus diltiazem 0.25 mg/kg IV push (with a 20 mg max) with repeat diltiazem bolus dose after 15 minutes if rate control not achieved 0.35mg/kg IV push. Calcium gluconate will not be administered with repeat doses of diltiazem. Weight-based dosing of diltiazem was most utilized, though some providers may elect to modify based on the clinical scenario. The primary outcome will be the mean difference in systolic blood pressure evaluated at 5 and 15 minutes after administration of diltiazem bolus. Secondary outcomes include decrease in heart rate, conversion to sinus rhythm, and adverse effects of medication administered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calcium pre-treatment | Active Comparator | Calcium gluconate 1 gram/100ml 0.9% NaCl or 100ml 0.9% NaCl |
|
| Placebo | Placebo Comparator | diluent (NS) vials |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcium pre-treatment | Drug | The intervention is Calcium gluconate 1 gram/100ml 0.9% NaCl or 100ml 0.9% NaCl) over 5 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Difference in Systolic Blood Pressure | Mean difference in systolic blood pressure after administration of diltiazem bolus. Monitors were set to obtain an automated full set of vitals every 5 minutes after administration of diltiazem. | Baseline to 5 Minutes |
| Mean Difference in Systolic Blood Pressure | Mean difference in systolic blood pressure evaluated after administration of diltiazem bolus. Monitors were set to obtain an automated full set of vitals every 5 minutes after administration of diltiazem. | Baseline to 10 Minutes |
| Mean Difference in Systolic Blood Pressure | Mean difference in systolic blood pressure after administration of diltiazem bolus. Monitors were set to obtain an automated full set of vitals every 5 minutes after administration of diltiazem | Baseline to 15 Minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Heart Rate | Mean difference in heart rate evaluated after administration of diltiazem bolus. Monitors were set to obtain an automated full set of vitals every 5 minutes after administration of diltiazem. | Baseline to 5 Minutes |
| Mean Change in Heart Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael V Cirone, MD | Advocate Aurora Health (AAH) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advocate Christ Medical Center Emergency Department (ACMC ED) | Oak Lawn | Illinois | 60453 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Calcium Pre-treatment | Calcium gluconate 1 gram/100ml 0.9% NaCl or 100ml 0.9% NaCl Calcium pre-treatment: The intervention is Calcium gluconate 1 gram/100ml 0.9% NaCl or 100ml 0.9% NaCl) over 5 minutes. |
| FG001 | Placebo | diluent (NS) vials Placebo: Placebo/ no calcium pre-treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Calcium Pre-treatment | Calcium gluconate 1 gram/100ml 0.9% NaCl or 100ml 0.9% NaCl Calcium pre-treatment: The intervention is Calcium gluconate 1 gram/100ml 0.9% NaCl or 100ml 0.9% NaCl) over 5 minutes. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Difference in Systolic Blood Pressure | Mean difference in systolic blood pressure after administration of diltiazem bolus. Monitors were set to obtain an automated full set of vitals every 5 minutes after administration of diltiazem. | Posted | Mean | Standard Deviation | mmHg | Baseline to 5 Minutes |
|
Adverse event data was collected at the 5 minutes, 10 minutes, and 15 minutes intervals after initiation of diltiazem infusion by the emergency department pharmacy staff associated with this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Calcium Pre-treatment | Calcium gluconate 1 gram/100ml 0.9% NaCl or 100ml 0.9% NaCl Calcium pre-treatment: The intervention is Calcium gluconate 1 gram/100ml 0.9% NaCl or 100ml 0.9% NaCl) over 5 minutes. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hypotension | General disorders | Systematic Assessment |
Limitations: this was a single-center study with a relatively small sample size, which may limit generalizability. There was variability in diltiazem dosing amongst providers. Additionally, variability in provider practice and in dosing and timing of administration was present with the use of magnesium sulfate for atrial flutter with rapid ventricular rate. The timing and dose of magnesium administration was not protocolized.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Cirone, MD | Advocate Health | 7086841710 | michael.cirone@aah.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 6, 2024 | Oct 17, 2025 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 12, 2024 | Jan 15, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Placebo | Other | Placebo/ no calcium pre-treatment. |
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Mean difference in heart rate evaluated after administration of diltiazem bolus. Monitors were set to obtain an automated full set of vitals every 5 minutes after administration of diltiazem. |
| Baseline to 10 Minutes |
| Mean Change in Heart Rate | Mean difference in heart rate evaluated after administration of diltiazem bolus. Monitors were set to obtain an automated full set of vitals every 5 minutes after administration of diltiazem. | Baseline to 15 Minutes |
| Heart Rhythm at 5 Minutes | Heart rhythm category after 5 minutes of initial diltiazem administration for treatment of AFF with RVR. | Baseline to 5 Minutes |
| Heart Rhythm at 15 Minutes | Heart rhythm category after 15 minutes of initial diltiazem administration for treatment of AFF with RVR. | Baseline to 15 Minutes |
diluent (NS) vials
Placebo: Placebo/ no calcium pre-treatment.
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Weight (kg) | Median | Inter-Quartile Range | kilograms |
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| Height (cm) | Median | Inter-Quartile Range | centimeters |
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| On rate Control Medicine (yes/no)? | Count of Participants | Participants |
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| Which Rate Control Agent? | Count of Participants | Participants |
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| On Rhythm Medication for PTA? | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Mean Difference in Systolic Blood Pressure | Mean difference in systolic blood pressure evaluated after administration of diltiazem bolus. Monitors were set to obtain an automated full set of vitals every 5 minutes after administration of diltiazem. | Posted | Mean | Standard Deviation | mmHg | Baseline to 10 Minutes |
|
|
|
| Primary | Mean Difference in Systolic Blood Pressure | Mean difference in systolic blood pressure after administration of diltiazem bolus. Monitors were set to obtain an automated full set of vitals every 5 minutes after administration of diltiazem | Posted | Mean | Standard Deviation | mmHg | Baseline to 15 Minutes |
|
|
|
| Secondary | Mean Change in Heart Rate | Mean difference in heart rate evaluated after administration of diltiazem bolus. Monitors were set to obtain an automated full set of vitals every 5 minutes after administration of diltiazem. | Posted | Mean | Standard Deviation | beats per minute | Baseline to 5 Minutes |
|
|
|
| Secondary | Mean Change in Heart Rate | Mean difference in heart rate evaluated after administration of diltiazem bolus. Monitors were set to obtain an automated full set of vitals every 5 minutes after administration of diltiazem. | Posted | Mean | Standard Deviation | beats per minute | Baseline to 10 Minutes |
|
|
|
| Secondary | Mean Change in Heart Rate | Mean difference in heart rate evaluated after administration of diltiazem bolus. Monitors were set to obtain an automated full set of vitals every 5 minutes after administration of diltiazem. | Posted | Mean | Standard Deviation | beats per minute | Baseline to 15 Minutes |
|
|
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| Secondary | Heart Rhythm at 5 Minutes | Heart rhythm category after 5 minutes of initial diltiazem administration for treatment of AFF with RVR. | Posted | Count of Participants | Participants | Baseline to 5 Minutes |
|
|
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| Secondary | Heart Rhythm at 15 Minutes | Heart rhythm category after 15 minutes of initial diltiazem administration for treatment of AFF with RVR. | Posted | Count of Participants | Participants | Baseline to 15 Minutes |
|
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| 0 |
| 44 |
| 0 |
| 44 |
| 5 |
| 44 |
| EG001 | Placebo | diluent (NS) vials Placebo: Placebo/ no calcium pre-treatment. | 0 | 39 | 0 | 39 | 2 | 39 |
| extravasation via Calcium Gluconate | General disorders | Systematic Assessment |
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| ringing in ears/chest pressure | General disorders | Systematic Assessment |
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| extravasation via CCB | General disorders | Systematic Assessment |
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| NSR |
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| NSR |
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