Role of IV Calcium to Prevent Diltiazem-related Hypotension (AFstd)

Haseki Training and Research Hospital

Status and phase: Completed; Phase 4

Conditions: Atrial Fibrillation; Hypotension Drug-Induced; Rapid Ventricular Response

Treatments: Drug: Sodium chloride; Drug: 180 mg Calcium; Drug: 90 mg of calcium

Study type: Interventional

Funder types: Other

Identifiers

NCT06494007

Haseki TRH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 217 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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217 participants in 3 patient groups

Diltiazem monotherapy

Active Comparator group

Description:

The Diltiazem monotherapy

Treatment:

Drug: Sodium chloride

Diltiazem with 90 mg calcium

Active Comparator group

Description:

Diltiazem with 90 mg calcium

Treatment:

Drug: 90 mg of calcium

The Diltiazem with 180 mg calcium

Active Comparator group

Description:

Diltiazem with 180 mg calcium

Treatment:

Drug: 180 mg Calcium