Role of IV Calcium to Prevent Diltiazem-related Hypotension

NCT06494007 | Completed Phase 4 DMC

• 1 other identifier: Haseki TRH
• Study Type: interventional
• Target: 217
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Rapid Ventricular Response; Hypotension Drug-Induced

Keywords

Atrial fibrillation; Rapid ventricular response; Diltiazem-related hypotension; IV Calcium

Outcome Measures

Primary Outcomes (1)

• 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.

  5, 10, and 15 minutes following the initial administration.

Secondary Outcomes (1)

• Change in Heart Rate before and after treatment

  5, 10, and 15 minutes following the initial administration

Other Outcomes (1)

• Assessing the treatment-related complications

  2 hours following the initial administration

Study Arms (3)

Diltiazem monotherapy

ACTIVE COMPARATOR

The Diltiazem monotherapy

Drug: Sodium chloride

Diltiazem with 90 mg calcium

ACTIVE COMPARATOR

Diltiazem with 90 mg calcium

Drug: 90 mg of calcium

The Diltiazem with 180 mg calcium

ACTIVE COMPARATOR

Diltiazem with 180 mg calcium

Drug: 180 mg Calcium

Interventions

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.

Diltiazem monotherapy

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.

Diltiazem with 90 mg calcium

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.

The Diltiazem with 180 mg calcium

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Haseki Training and Research Hospital: lead

Study Sites (1)

Haseki Training and Research Hospital

Istanbul, Fatih, 34265, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 36442264 RESULT

• 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.

  PMID: 15093843 RESULT

• 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.

  PMID: 1539892 RESULT

• 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.

  PMID: 7056937 RESULT

• Az A, Sogut O, Dogan Y, Akdemir T, Ergenc H, Umit TB, Celik AF, Armagan BN, Bilici E, Cakmak S. Reducing diltiazem-related hypotension in atrial fibrillation: Role of pretreatment intravenous calcium. Am J Emerg Med. 2025 Feb;88:23-28. doi: 10.1016/j.ajem.2024.11.033. Epub 2024 Nov 17.

  PMID: 39577214 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Hypotension

Interventions

Sodium Chloride; Calcium

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Metals, Alkaline Earth; Elements; Metals; Blood Coagulation Factors; Biological Factors

Study Officials

• Adem Az, M.D.

  Haseki Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: Single center

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 10, 2024
• Study Start: January 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: July 1, 2024
• Last Updated: July 11, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)