Ignite Creation Date:
2024-07-17 @ 11:03 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06494007
Status:
COMPLETED
Last Update Posted:
2024-07-11
First Post:
2024-07-01
Brief Title:
Role of IV Calcium to Prevent Diltiazem-related Hypotension
Sponsor:
Haseki Training and Research Hospital
Organization:
Haseki Training and Research Hospital
Study Overview
Official Title:
Reducing Diltiazem-Related Hypotension in Atrial Fibrillation The Role of IV Calcium Pretreatment
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AFstd
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 lt100 bpm a reduction in HR by gt20 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 035 mgkg 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 AFibAFL 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None