Pre-diltiazem, Calcium Versus Placebo for Atrial Fibrillation With Rapid Ventricular Response

Sponsor

Ascension Genesys Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05691959

Collaborator

(none)

378

Enrollment

Arms

24.2

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The goal of this randomized double blind controlled trial is to learn about the effects of calcium when it is given prior to diltiazem for patients with atrial fibrillation ( a type of irregular heart beat) who have rapid ventricular response ( a pulse over 100 beats per minute). Normally diltiazem 0.25mg/kg (max 20mg) is given to slow the heart rate. We will give Placebo versus Calcium Gluconate 2gm given prior to diltiazem.

The main questions it aims to answer are:

Does calcium decrease the incidence of low blood pressure (a side effect of diltiazem)?
How does calcium effect the action of diltiazem? Does it interfere with the desired decrease in heart rate?

Participants will receive either placebo or calcium immediately prior to the administration of diltiazem. Their blood pressure and pulse will be measured:

prior to study drug administration
post study drug and prior to diltiazem administration
3 minutes post start of diltiazem
5 minutes post start of diltiazem
10 minutes post start of diltiazem
20 minutes post start of diltiazem
30 minutes post start of diltiazem

Researchers will compare the placebo group to the calcium group to see if there is a difference in the blood pressure and pulse.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation With Rapid Ventricular Response Hypotension	Drug: Placebo Drug: Calcium	Phase 2

Detailed Description

Diltiazem, a calcium channel blocker is the standard of care for treatment of stable patients with atrial fibrillation and rapid ventricular response. Many emergency physicians opine that calcium, the "antidote" for calcium channel blockers, when given prior to diltiazem administration, mitigates the common adverse effect of hypotension.

In order to obtain evidence related to this belief, we will study the effects of placebo (normal saline 50ml) versus calcium gluconate (2 grams in normal saline 50ml). Hemodynamically stable patients in afib with rvr will be identified on their arrival to the emergency department. Those who consent to the study will be enrolled and the pharmacy will be contacted to provide a blinded study sample to the patient's bedside. After initial vital signs are recorded the study sample will be infused via pump over a 10 minute period. Vitals will be recorded on its completion and a diltiazem bolus (0.25mg/kg, max 20mg) will be administered. Vitals will be recorded at 3, 5, 10, 20 and 30 minutes post start of diltiazem bolus.

The primary outcome of hypotension will be calculated using rates (frequencies). The rate of hypotension will be compared between the two groups using Chi square analysis. The groups will be compared for similarity using means(sd) and frequencies(percentages). Any variables that differ by group will be controlled for with a multiple logistic regression analysis.

A 35% rate of hypotension is estimated for the placebo group and a hypothesized 22% in the treatment group (a relative 37% decrease). This will require a minimum total sample size of 378 (184/ group) . We may terminate the study earlier if we achieve power.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

378 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized Placebo Controlled Double Blind StudyRandomized Placebo Controlled Double Blind Study

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Each formulation is masked by the pharmacy department.

Primary Purpose:

Treatment

Official Title:

Calcium Administration to Prevent Hypotension Caused by Diltiazem Administration in the Treatment of Atrial Fibrillation With Rapid Ventricular Response

Anticipated Study Start Date :

Jan 26, 2023

Anticipated Primary Completion Date :

Jan 31, 2025

Anticipated Study Completion Date :

Jan 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Normal Saline Normal saline 50 ml intravenous piggyback once over 10 minutes	Drug: Placebo Patients randomized to placebo group will receive Normal Saline 50ml IV. Other Names: Normal saline
Experimental: Calcium chloride x grams in 50 ml ivpb once over 10 minutes	Drug: Calcium Patients randomized to the study group will receive Calcium 2gm in Normal Saline 50ml IV. Other Names: Study drug

Arm

Intervention/Treatment

Placebo Comparator: Normal Saline

Normal saline 50 ml intravenous piggyback once over 10 minutes

Drug: Placebo

Patients randomized to placebo group will receive Normal Saline 50ml IV.

Other Names:

Normal saline

Experimental: Calcium chloride

x grams in 50 ml ivpb once over 10 minutes

Drug: Calcium

Patients randomized to the study group will receive Calcium 2gm in Normal Saline 50ml IV.

Other Names:

Study drug

Outcome Measures

Primary Outcome Measures

Hypotension [Thirty minutes from time of drug administration]
Mean arterial blood pressure less than 70mm Hg

Secondary Outcome Measures

Heart rate [Thirty minutes from drug administration]
Decrease below 100 beats per minute

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria: Diagnosis of atrial fibrillation with rapid ventricular response (ventricular rate over 100 bpm) due to an electrophysiologic etiology.