NCT06494007

Role of IV Calcium to Prevent Diltiazem-related Hypotension

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 217 (actual)
• Sponsor: Haseki Training and Research Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Atrial Fibrillation
• Rapid Ventricular Response
• Hypotension Drug-Induced

Interventions

Type	Name	Description
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.
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.
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.

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-06-01
• Completion: 2024-07-01
• First posted: 2024-07-10
• Last updated: 2024-07-11

Locations

1 site across 1 country: Turkey (Türkiye)