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The objective of this study is to examine the efficacy and safety of IV calcium pretreatment at varying doses prior to weight-adjusted IV Diltiazem on the incidence of Diltiazem-related hypotension in adult patients presenting to the Emergency Department due to Atrial Fibrillation with Rapid Ventricular Response. Specifically, we tested the hypothesis that patients with Atrial Fibrillation who receive IV calcium pretreatment prior to IV Diltiazem suffer less hypotension than those receiving Diltiazem monotherapy.
Patients were randomly divided into one of three groups. We assessed the Systolic Blood Pressure and Heart Rate of participants before treatment and 5, 10, and 15 min after treatment among the patient groups. Successful rhythm control was defined as achieving an HR of <100 bpm, a reduction in HR by >20% compared to baseline, or the restoration of normal sinus rhythm (NSR). If adequate rhythm control was not achieved within 15 min of the initial treatment, we administered 0.35 mg/kg of IV diltiazem slowly over 2 minutes as a rescue treatment. The need for rescue treatment or any intervention for hypotension, as well as any adverse effects, were recorded in a prepared data form. Also, patient demographics (age and sex), new onset versus chronic AFib/AFL, relevant medical history, vital signs on admission (SBP and HR), complaints and symptoms on admission, and laboratory parameters were documented in a prepared data form.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diltiazem monotherapy | Active Comparator | The Diltiazem monotherapy |
|
| Diltiazem with 90 mg calcium | Active Comparator | Diltiazem with 90 mg calcium |
|
| The Diltiazem with 180 mg calcium | Active Comparator | Diltiazem with 180 mg calcium |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium chloride | Drug | The Diltiazem monotherapy group received 6.66 mL of IV sodium chloride 0.9% (NaCl) prior to receiving IV weight-adjusted diltiazem. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Systolic blood pressure before and after treatment | We investigated the change in systolic blood pressure at 5, 10, and 15 minutes following the initial IV diltiazem administration comparatively among treatment groups. | 5, 10, and 15 minutes following the initial administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Heart Rate before and after treatment | We also investigated the change in Heart rate values at 5, 10, and 15 minutes following the initial IV diltiazem administration comparatively among treatment groups. | 5, 10, and 15 minutes following the initial administration |
| Measure | Description | Time Frame |
|---|---|---|
| Assessing the treatment-related complications | We also evaluated treatment-related adverse effects, hypotension, and hypercalcemia. | 2 hours following the initial administration |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adem Az, M.D. | Haseki Training and Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haseki Training and Research Hospital | Istanbul | Fatih | 34265 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36442264 | Result | Rossi N, Allen B, Hailu K, Kamataris K, Ryan C. Impact of intravenous calcium with diltiazem for atrial fibrillation/flutter in the emergency department. Am J Emerg Med. 2023 Feb;64:57-61. doi: 10.1016/j.ajem.2022.11.018. Epub 2022 Nov 17. | |
| 15093843 | Result | 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. |
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Stored in non-publicly available Available on request
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D002118 | Calcium |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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Single center
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Each participant was assigned an identification number indicating their treatment group. An emergency nurse prepared the treatment solutions just before administration based on the assigned identification number and stored them in labeled containers with no indication of their content. A clinician with eight years of experience, who was blinded to the study's null hypothesis and did not participate in the evaluation of results, administered the treatments and recorded patient data onto a pre-prepared case data form. Another physician, who was not present during the treatment, assessed the findings post-treatment.
| 90 mg of calcium | Drug | The Diltiazem with 90 mg calcium group received 3.33 mL of IV calcium chloride (CaCl2, 90 mg) and 3.33 mL of IV NaCl 0.9% as pretreatment over 5-10 min prior to receiving IV diltiazem. |
|
| 180 mg Calcium | Drug | The Diltiazem with 180 mg calcium group received 6.66 mL of IV CaCl2 (180 mg) as pretreatment prior to receiving IV diltiazem. |
|
| 1539892 | Result | Jameson SJ, Hargarten SW. Calcium pretreatment to prevent verapamil-induced hypotension in patients with SVT. Ann Emerg Med. 1992 Jan;21(1):68. doi: 10.1016/s0196-0644(05)82242-5. No abstract available. |
| 7056937 | Result | Lipman J, Jardine I, Roos C, Dreosti L. Intravenous Calcium chloride as an antidote to verapamil-induced hypotension. Intensive Care Med. 1982 Jan;8(1):55-7. doi: 10.1007/BF01686855. No abstract available. |
| 39577214 | Derived | Az A, Sogut O, Dogan Y, Akdemir T, Ergenc H, Umit TB, Celik AF, Armagan BN, Bilici E, Cakmak S. Reducing diltiazem-related hypotension in atrial fibrillation: Role of pretreatment intravenous calcium. Am J Emerg Med. 2025 Feb;88:23-28. doi: 10.1016/j.ajem.2024.11.033. Epub 2024 Nov 17. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D017670 |
| Sodium Compounds |
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D008670 | Metals |
| D001779 | Blood Coagulation Factors |
| D001685 | Biological Factors |