Role of IV Calcium to Prevent Diltiazem-related Hypotension

Phase 4

Completed

• Conditions: Hypotension Drug-Induced; Atrial Fibrillation; Rapid Ventricular Response
• Interventions: Drug: 90 mg of calcium; Drug: 180 mg Calcium; Drug: Sodium chloride

• Registration Number: NCT06494007
• Lead Sponsor: Haseki Training and Research Hospital

Brief 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 p...

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 nor...

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2023-01-01
• Primary Completion: 2024-06-01
• Status Verified: 2024-07
• Study Completion: 2024-07-01
• Study First Submitted: 2024-07-01
• Study First Submitted QC: 2024-07-02
• Last Update Submitted: 2024-07-09
• Study First Posted: 2024-07-10
• Last Update Posted: 2024-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 217

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Diltiazem with 90 mg calcium	90 mg of calcium	Diltiazem with 90 mg calcium
The Diltiazem with 180 mg calcium	180 mg Calcium	Diltiazem with 180 mg calcium
Diltiazem monotherapy	Sodium chloride	The Diltiazem monotherapy

Primary Outcome Measures

Name	Time	Method
Change in Systolic blood pressure before and after treatment	5, 10, and 15 minutes following the initial administration.	We investigated the change in systolic blood pressure at 5, 10, and 15 minutes following the initial IV diltiazem administration comparatively among treatment groups.

Secondary Outcome Measures

Name	Time	Method
Change in Heart Rate before and after treatment	5, 10, and 15 minutes following the initial administration	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.

Trial Locations

Locations (1)

Haseki Training and Research Hospital; 🇹🇷 Istanbul, Fatih, Turkey