Low Versus High Dose Magnesium Sulfate in the Early Manag... | NCT00965874

Studies
Low Versus High Dose Magnesium Sulfate in the Early Management of Rapid Atrial Fibrillation

NCT00965874

Sponsor

University of Monastir

Status

Completed

Last Update Posted

Apr 20, 2018Actual

Enrollment

450Actual

Phase

Phase 3

Conditions

Atrial Fibrillation

Interventions

Magnesium Sulfate high dose
Magnesium Sulfate low dose
Placebos

Countries

Tunisia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009Actual

Primary Completion Date

Apr 2014Actual

Completion Date

Aug 2014Actual

First Submitted Date

Aug 24, 2009

First Submission Date that Met QC Criteria

Aug 25, 2009

First Posted Date

Aug 26, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 18, 2018

Last Update Posted Date

Apr 20, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Pr. Semir Nouira, Professor, University of MonastirPrincipal Investigator

Lead Sponsor

University of MonastirOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Objective:

To assess the efficacy and the safety of high (9g) and low dose (4.5g) of MgS in the immediate treatment of rapid AF.

Detailed Description

Introduction:

Atrial fibrillation (AF) is a potentially life-threatening cardiac arrhythmia and a frequent chief complaint in emergency departments (ED). It is an important concern for a substantial proportion of people worldwide. According to the Rotterdam study, the prevalence of AF among individuals aged between 55 to 59 years is estimated at 1.1 for 1000 persons/year and 20.7 for individuals between 80 and 84 years. Given current adult advanced cardiac life support (ACLS), the immediate clinical objective in rapid AF is to achieve ventricular rate control. Digoxin, beta blockers and calcium channel antagonists are the most widely used agents for the emergent treatment of rapid AF. However, their effect is limited because only half of the patients will acutely respond to the first intention treatment. Several studies showed that the magnesium sulfate (MgS) is beneficial in the control of the rate and the rhythm of AF. In addition, hypomagnesemia is present among patients having AF in 20 to 53% of the cases . The association of hypomagnesemia and AF is common after a cardiac surgery and the prophylactic administration of MgS could be useful in post-operative AF .

The last meta analysis published in 2007 showed that the MgS is as well efficient in rate control (OR = 1.96) as in rhythm control (OR = 1.60) of AF. However most studies included in this meta analysis were conducted on limited number of patients (303 patients included for rate control outcome analysis and 376 for rhythm control). Consequently we need further randomized controlled studies to establish definitively the efficacy and the safety of MgS in the early management of rapid AF.

Objective:

To assess the efficacy and the safety of high (9g) and low dose (4.5g) of MgS in the immediate treatment of rapid AF.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

450Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Magnesium Sulfate high dose infusion	Experimental	9 g Magnesium sulfate infusion over 30 minutes	Drug: Magnesium Sulfate high dose
Magnesium Sulfate low dose infusion	Active Comparator	4.5 magnesium sulfate infusion over 30 minutes	Drug: Magnesium Sulfate low dose
placebo	Placebo Comparator	serum salin	Drug: Placebos

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Magnesium Sulfate high dose	Drug	9 g infusion once during 30 minutes	Magnesium Sulfate high dose infusion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HR <90 bpm or 20% reduction from baseline at 24 hours		24 hours

Secondary Outcomes

Measure	Description	Time Frame
Arterial hypotension Bradycardia (HR <45 bpm) Other (chest pain, allergic reaction……)		24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients presenting to ED with rapid AF (Heart rate >120 bpm).

Exclusion Criteria:

Unstable hemodynamic state.
Renal insufficiency (creatinemia> 180 µmol/l).
Allergy to MgS.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
nouira semir, MD	University of Monastir	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Monastir		Monastir	Monstir	5000	Tunisia

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation
D001145	Arrhythmias, Cardiac

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008278	Magnesium Sulfate

Ancestor Terms

ID	Term
D017616	Magnesium Compounds
D007287	Inorganic Chemicals
D013431	Sulfates
D013464	Sulfuric Acids

Browse Leaves

Not provided

Browse Branches

Not provided