Role of IV Calcium to Prevent Diltiazem-related Hypotension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

217 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-07-01

Brief Summary

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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.

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Detailed Description

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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

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Atrial Fibrillation Rapid Ventricular Response Hypotension Drug-Induced

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Single center

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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.

Study Groups

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Diltiazem monotherapy

The Diltiazem monotherapy

Group Type ACTIVE_COMPARATOR

Sodium chloride

Intervention Type DRUG

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

Diltiazem with 90 mg calcium

Group Type ACTIVE_COMPARATOR

90 mg of calcium

Intervention Type 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.

The Diltiazem with 180 mg calcium

Diltiazem with 180 mg calcium

Group Type ACTIVE_COMPARATOR

180 mg Calcium

Intervention Type DRUG

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

Interventions

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Sodium chloride

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

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No