Role of IV Calcium to Prevent Diltiazem-related Hypotension

Haseki Training and Research Hospital217 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

217

Conditions

Atrial Fibrillation

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 5, 10, and 15 minutes following the initial administration.

Secondary Outcomes

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.

Time frame: 5, 10, and 15 minutes following the initial administration