Atrial Fibrillation, Hypotension Drug-Induced, Rapid Ventricular Response
Conditions
Keywords
Atrial fibrillation, Rapid ventricular response, Diltiazem-related hypotension, IV Calcium
Brief 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.
Detailed 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.
Interventions
DRUGSodium chloride
The Diltiazem monotherapy group received 6.66 mL of IV sodium chloride 0.9% (NaCl) prior to receiving IV weight-adjusted diltiazem.
DRUG90 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.
DRUG180 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.
Sponsors
Haseki Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
Single center
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Systolic blood pressure before and after treatment | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Heart Rate before and after treatment | 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
| Measure | Time frame | Description |
|---|---|---|
| Assessing the treatment-related complications | 2 hours following the initial administration | We also evaluated treatment-related adverse effects, hypotension, and hypercalcemia. |
Countries
Turkey (Türkiye)
Outcome results
None listed