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The goal of this randomized double blind controlled trial is to learn about the effects of calcium when it is given prior to diltiazem for patients with atrial fibrillation ( a type of irregular heart beat) who have rapid ventricular response ( a pulse over 100 beats per minute). Normally diltiazem 0.25mg/kg (max 20mg) is given to slow the heart rate. We will give Placebo versus Calcium Gluconate 2gm given prior to diltiazem.
The main questions it aims to answer are:
Participants will receive either placebo or calcium immediately prior to the administration of diltiazem. Their blood pressure and pulse will be measured:
Researchers will compare the placebo group to the calcium group to see if there is a difference in the blood pressure and pulse.
Diltiazem, a calcium channel blocker is the standard of care for treatment of stable patients with atrial fibrillation and rapid ventricular response. Many emergency physicians opine that calcium, the "antidote" for calcium channel blockers, when given prior to diltiazem administration, mitigates the common adverse effect of hypotension.
In order to obtain evidence related to this belief, we will study the effects of placebo (normal saline 50ml) versus calcium gluconate (2 grams in normal saline 50ml). Hemodynamically stable patients in afib with rvr will be identified on their arrival to the emergency department. Those who consent to the study will be enrolled and the pharmacy will be contacted to provide a blinded study sample to the patient's bedside. After initial vital signs are recorded the study sample will be infused via pump over a 10 minute period. Vitals will be recorded on its completion and a diltiazem bolus (0.25mg/kg, max 20mg) will be administered. Vitals will be recorded at 3, 5, 10, 20 and 30 minutes post start of diltiazem bolus.
The primary outcome of hypotension will be calculated using rates (frequencies). The rate of hypotension will be compared between the two groups using Chi square analysis. The groups will be compared for similarity using means(sd) and frequencies(percentages). Any variables that differ by group will be controlled for with a multiple logistic regression analysis.
A 35% rate of hypotension is estimated for the placebo group and a hypothesized 22% in the treatment group (a relative 37% decrease). This will require a minimum total sample size of 378 (184/ group) . We may terminate the study earlier if we achieve power.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Saline | Placebo Comparator | Normal saline 50 ml intravenous piggyback once over 10 minutes |
|
| Calcium chloride | Experimental | x grams in 50 ml ivpb once over 10 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Patients randomized to placebo group will receive Normal Saline 50ml IV. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hypotension | Mean arterial blood pressure less than 70mm Hg | Thirty minutes from time of drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate | Decrease below 100 beats per minute | Thirty minutes from drug administration |
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Inclusion Criteria: Diagnosis of atrial fibrillation with rapid ventricular response (ventricular rate over 100 bpm) due to an electrophysiologic etiology.
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Exclusion Criteria:
Unstable, requiring electric cardioversion -hypotensive
Patients at risk of hypercalcemia - renal failure
Know cardiac valvular disease
Allergic to calcium gluconate or diltiazem
Underlying cardiac disease - sick sinus syndrome
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Virginia A LaBond, MS MD | Contact | 810-606-5000 | virginia.labond@ascension.org | |
| Tara Knisley, MD | Contact | 810-606-5000 | tara.knisley@ascension.org |
| Name | Affiliation | Role |
|---|---|---|
| Virginia A LaBond, MS MD | Ascension Health | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2331904 | Background | Barnett JC, Touchon RC. Short-term control of supraventricular tachycardia with verapamil infusion and calcium pretreatment. Chest. 1990 May;97(5):1106-9. doi: 10.1378/chest.97.5.1106. | |
| 3718093 | Background | Haft JI, Habbab MA. Treatment of atrial arrhythmias. Effectiveness of verapamil when preceded by calcium infusion. Arch Intern Med. 1986 Jun;146(6):1085-9. doi: 10.1001/archinte.146.6.1085. |
| Label | URL |
|---|---|
| rate control therapy | View source |
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| ID | Term |
|---|---|
| D007022 | Hypotension |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D002118 | Calcium |
| D004341 | Drug Evaluation |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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Randomized Placebo Controlled Double Blind Study
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Each formulation is masked by the pharmacy department.
| Calcium | Drug | Patients randomized to the study group will receive Calcium 2gm in Normal Saline 50ml IV. |
|
|
| 15093843 | Background | Kolkebeck T, Abbrescia K, Pfaff J, Glynn T, Ward JA. Calcium chloride before i.v. diltiazem in the management of atrial fibrillation. J Emerg Med. 2004 May;26(4):395-400. doi: 10.1016/j.jemermed.2003.12.020. |
| 20825912 | Background | Lee J, Kim K, Lee CC, Nam YW, Lee JH, Rhee JE, Singer AJ, Kim KS, Ro Y. Low-dose diltiazem in atrial fibrillation with rapid ventricular response. Am J Emerg Med. 2011 Oct;29(8):849-54. doi: 10.1016/j.ajem.2010.03.021. Epub 2010 May 1. |
| 10852091 | Background | Moser LR, Smythe MA, Tisdale JE. The use of calcium salts in the prevention and management of verapamil-induced hypotension. Ann Pharmacother. 2000 May;34(5):622-9. doi: 10.1345/aph.18318. |
| calcium gluconate drug information | View source |
| diltiazem drug information | View source |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008673 |
| Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
| D001779 | Blood Coagulation Factors |
| D001685 | Biological Factors |
| D000076722 | Drug Development |
| D008919 | Investigative Techniques |
| D005069 | Evaluation Studies as Topic |