Role of IV Calcium to Prevent Diltiazem-related Hypotension (AFstd)

Reducing Diltiazem-Related Hypotension in Atrial Fibrillation: The Role of IV Calcium Pretreatment

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Hypotension Drug-Induced; Rapid Ventricular Response
• Intervention / Treatment: Drug: Sodium chloride; Drug: 90 mg of calcium; Drug: 180 mg Calcium

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 217
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Fatih
    • Istanbul, Fatih, Turkey, 34265
      • Haseki Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients aged ≥ 18 years
• Patients with documented AFib/AFL (confirmed by ECG)
• Patients with a Heart Rate of ≥ 120 bpm, and a Systolic Blood Pressure of ≥ 90 mmHg

Exclusion Criteria:

• Patients under 18 years of age
• pregnant individuals
• Patients with hemodynamic instability requiring electrocardioversion
• Patients with a documented history of sick sinus syndrome, third-degree AV block, Wolff-Parkinson-White syndrome
• Patients with hypotension (SBP <90 mmHg)
• Patients with known or suspected hypercalcemia
• Patients with a confirmed allergy to diltiazem
• Patients with concurrent use of another Heart Rate control agent (such as beta-blockers, amiodarone, or digoxin) on the same admission

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Diltiazem monotherapy; The Diltiazem monotherapy	Drug: Sodium chloride; The Diltiazem monotherapy group received 6.66 mL of IV sodium chloride 0.9% (NaCl) prior to receiving IV weight-adjusted diltiazem.
Active Comparator: Diltiazem with 90 mg calcium	Drug: 90 mg of calcium; 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.
Active Comparator: The Diltiazem with 180 mg calcium; Diltiazem with 180 mg calcium	Drug: 180 mg Calcium; The Diltiazem with 180 mg calcium group received 6.66 mL of IV CaCl2 (180 mg) as pretreatment prior to receiving IV diltiazem.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Haseki Training and Research Hospital
• Investigators: Principal Investigator: Adem Az, M.D., Haseki Training and Research Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): June 1, 2024
• Study Completion (Actual): July 1, 2024

Study Registration Dates

• First Submitted: July 1, 2024
• First Submitted That Met QC Criteria: July 2, 2024
• First Posted (Actual): July 10, 2024

Study Record Updates

• Last Update Posted (Actual): July 11, 2024
• Last Update Submitted That Met QC Criteria: July 9, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Atrial fibrillation; Rapid ventricular response; Diltiazem-related hypotension; IV Calcium
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Hypotension; Physiological Effects of Drugs; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Calcium; Calcium, Dietary
• Other Study ID Numbers: Haseki TRH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Stored in non-publicly available Available on request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes