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Completed

NCT Number: NCT06494007

Role of IV Calcium to Prevent Diltiazem-related Hypotension

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Haseki Training and Research Hospital

Istanbul, Fatih, 34265, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sodium Chloride

Drug

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 calcium

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.

180 mg Calcium

Drug

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

Primary outcomes

  1. Change in Systolic blood pressure before and after treatment

    Time frame: 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 outcomes

  1. Change in Heart Rate before and after treatment

    Time frame: 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.

Other outcomes

  1. Assessing the treatment-related complications

    Time frame: 2 hours following the initial administration

    We also evaluated treatment-related adverse effects, hypotension, and hypercalcemia.

Sponsors and collaborators

Lead sponsor

Haseki Training and Research Hospital

Other

Registry information

Official study title

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

Acronym: AFstd

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 10, 2024
Registry last updated
Jul 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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