Hypotension Clinical Trial
Official title:
Calcium Administration to Prevent Hypotension Caused by Diltiazem Administration in the Treatment of Atrial Fibrillation With Rapid Ventricular Response
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: - Does calcium decrease the incidence of low blood pressure (a side effect of diltiazem)? - How does calcium effect the action of diltiazem? Does it interfere with the desired decrease in heart rate? Participants will receive either placebo or calcium immediately prior to the administration of diltiazem. Their blood pressure and pulse will be measured: - prior to study drug administration - post study drug and prior to diltiazem administration - 3 minutes post start of diltiazem - 5 minutes post start of diltiazem - 10 minutes post start of diltiazem - 20 minutes post start of diltiazem - 30 minutes post start of diltiazem Researchers will compare the placebo group to the calcium group to see if there is a difference in the blood pressure and pulse.
Status | Not yet recruiting |
Enrollment | 378 |
Est. completion date | January 31, 2025 |
Est. primary completion date | January 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: Diagnosis of atrial fibrillation with rapid ventricular response (ventricular rate over 100 bpm) due to an electrophysiologic etiology. - Exclusion Criteria: 1. Unstable, requiring electric cardioversion -hypotensive - altered mental status - myocardial infarction - pulmonary hypertension 2. Patients at risk of hypercalcemia - renal failure 3. Know cardiac valvular disease 4. Allergic to calcium gluconate or diltiazem 5. Underlying cardiac disease - sick sinus syndrome - 2nd/3rd degree atrial ventricular block - cardiogenic shock - recent IV beta blocker administration - accession bypass tract (WPW, short PR) |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Ascension Genesys Hospital |
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hypotension | Mean arterial blood pressure less than 70mm Hg | Thirty minutes from time of drug administration | |
Secondary | Heart rate | Decrease below 100 beats per minute | Thirty minutes from drug administration |
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