CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 217 enrolled
Drug / intervention
Sodium chloride +2 moredrug
Likely dose
90 mg of calciumfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06494007
NCT06494007Phase 4Completed

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

Haseki Training and Research Hospital·interventional·Posted Jul 10, 2024·Updated Jul 11, 2024

In Brief

A Phase 4 clinical trial evaluating Sodium chloride, 90 mg of calcium, and 1 other intervention for Atrial Fibrillation and 2 related conditions. Completed, enrolled 217 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTurkey (Türkiye)
Collaborators--

Timeline

Phase 4CompletedFinished
2023202420252026
First PostedJul 10, 2024
Enrollment StartJan 1, 2023
Primary CompletionJun 1, 2024
Study CompletionJul 1, 2024
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 2.0 years ago

Interventions

Sodium chloridedrug

The Diltiazem monotherapy group received 6.66 mL of IV sodium chloride 0.9% (NaCl) prior to receiving IV weight-adjusted diltiazem.

90 mg of calciumdrug

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 Calciumdrug

The Diltiazem with 180 mg calcium group received 6.66 mL of IV CaCl2 (180 mg) as pretreatment prior to receiving IV diltiazem.