Clinical trial NCT06494007: Role of IV Calcium to Prevent Diltiazem-related Hypotension
Official title: Reducing Diltiazem-Related Hypotension in Atrial Fibrillation: The Role of IV Calcium Pretreatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Fibrillation
Rapid Ventricular Response
Hypotension Drug-Induced
Keywords: Atrial fibrillation
Rapid ventricular response
Diltiazem-related hypotension
IV Calcium
Lead sponsor: Haseki Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-07-10
Enrollment: 217
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Single center
Primary purpose: PREVENTION

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 \&lt;100 bpm, a reduction in HR by \&gt;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.

Eligibility criteria: 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 \&lt;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

Primary outcomes:
measure: Change in Systolic blood pressure before and after treatment
timeFrame: 5, 10, and 15 minutes following the initial administration.
Secondary outcomes:
measure: Change in Heart Rate before and after treatment
timeFrame: 5, 10, and 15 minutes following the initial administration
Other outcomes:
measure: Assessing the treatment-related complications
timeFrame: 2 hours following the initial administration
Locations:
city: Istanbul
country: Turkey
facility: Haseki Training and Research Hospital
state: Fatih
Study officials:
affiliation: Haseki Training and Research Hospital
name: Adem Az, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rossi N, Allen B, Hailu K, Kamataris K, Ryan C. Impact of intravenous calcium with diltiazem for atrial fibrillation/flutter in the emergency department. Am J Emerg Med. 2023 Feb;64:57-61. doi: 10.1016/j.ajem.2022.11.018. Epub 2022 Nov 17.
citation: Kolkebeck T, Abbrescia K, Pfaff J, Glynn T, Ward JA. Calcium chloride before i.v. diltiazem in the management of atrial fibrillation. J Emerg Med. 2004 May;26(4):395-400. doi: 10.1016/j.jemermed.2003.12.020.
citation: Jameson SJ, Hargarten SW. Calcium pretreatment to prevent verapamil-induced hypotension in patients with SVT. Ann Emerg Med. 1992 Jan;21(1):68. doi: 10.1016/s0196-0644(05)82242-5. No abstract available.
citation: Lipman J, Jardine I, Roos C, Dreosti L. Intravenous Calcium chloride as an antidote to verapamil-induced hypotension. Intensive Care Med. 1982 Jan;8(1):55-7. doi: 10.1007/BF01686855. No abstract available.