Back to resultsMagnesium Sulphate for Treatment of New Onset Atrial Fibrillation in Medical Intensive Care Unit Patient (EMSAF)
Primary Purpose
Atrial Fibrillation
Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Placebo
Magnesium sulphate
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Hemodynamically unstable patients, Magnesium sulfate, Septic shock, Medical intensive care unit, New onset atrial fibrillation, Critically ill patients
Eligibility Criteria
Inclusion Criteria:
- Admitted in medical intensive care unit
- Age 18 years or more
- New onset atrial fibrillation (within 48 hours), persist for at least 1 hour, ventricular rate 120 beats per min or more without evidence of volume depletion (CVP 8 mmHg or more or receive volume resuscitation about 20-30 ml/kg), oxygen saturation not less than 90%, serum Potassium level between 3.0-5.0 mEq/l, serum Calcium level between 8.0-11.0 mg/dl
Exclusion Criteria:
- Chronic atrial fibrillation
- Severe valvular heart disease including severe mitral regurgitation, mitral stenosis, aortic regurgitation, aortic stenosis, tricuspid regurgitation, tricuspid stenosis, pulmonic regurgitation or pulmonic stenosis
- Indicated for electrical cardioversion
- Severe hypomagnesemia (serum Magnesium < 1.2 mg/dl)
- Severe hypermagnesemia (serum Magnesium > 5.0 mg/dl)
- Renal insufficiency with creatinine > 3.0 mg/dl without renal replacement therapy
Sites / Locations
- Faculty of Medicine, Siriraj Hospital, Mahidol UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
5%D/W
Magnesium sulphate
Arm Description
The patients in this group will receive 5%D/W 20 ml intravenous in 10 min and then 5%D/W 100 ml infusion in 6 hours as the placebo drug.
The patients in this group will receive 2g of Magnesium sulphate diluted with 5%D/W into 20 ml solution, infusion intravenously in 10 min then 6g of Magnesium sulphate diluted with 5%D/W into 100 ml solution, infusion intravenously in 6 hours
Outcomes
Primary Outcome Measures
Rate of conversion to sinus rhythm and/or ventricular rate less than 120 beats per min
Secondary Outcome Measures
Blood pressure, superior vena cava or mixed venous oxygen saturation, cardiac index, inotropic and vasopressors dosage
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01049464
Brief Title
Magnesium Sulphate for Treatment of New Onset Atrial Fibrillation in Medical Intensive Care Unit Patient
Acronym
EMSAF
Official Title
Efficacy of Magnesium Sulphate for Rate and Rhythm Control of New-onset Atrial Fibrillation in the Medical Critically Ill Patients: A Randomized, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
January 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the efficacy of Magnesium sulphate for the rate and rhythm control of the new onset (within 48 hours) atrial fibrillation in the hemodynamically unstable patients, admitted in the medical intensive care unit patients.
Detailed Description
Atrial fibrillation is one of the most common arrhythmia, reported in the hemodynamically unstable patients in the intensive care unit. Loss of atrial contraction and the sequential atrioventricular contraction decrease the overall cardiac output which results in severe inadequate tissue perfusion. Medications aim for rate and rhythm control are recommended to treat new onset atrial fibrillation. These drugs (verapamil, diltiazem, amiodarone and beta blockers) may further compromise the patients' cardiac output by its' negative inotropic effect.
Magnesium sulphate with the cell membrane threshold potential stabilizing effect has been reported as an effective drug for rate and rhythm control for post-operative atrial fibrillation and the atrial fibrillation presented in the hospital emergency unit. However, there was inadequate data about the efficacy of Magnesium sulphate for treatment of new onset atrial fibrillation in the hemodynamically unstable patients admitted in the medical intensive care unit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial fibrillation, Hemodynamically unstable patients, Magnesium sulfate, Septic shock, Medical intensive care unit, New onset atrial fibrillation, Critically ill patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
5%D/W
Arm Type
Placebo Comparator
Arm Description
The patients in this group will receive 5%D/W 20 ml intravenous in 10 min and then 5%D/W 100 ml infusion in 6 hours as the placebo drug.
Arm Title
Magnesium sulphate
Arm Type
Experimental
Arm Description
The patients in this group will receive 2g of Magnesium sulphate diluted with 5%D/W into 20 ml solution, infusion intravenously in 10 min then 6g of Magnesium sulphate diluted with 5%D/W into 100 ml solution, infusion intravenously in 6 hours
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
5%D/W
Intervention Description
5%D/W 20 ml intravenous in 10 min then 5%D/W 100 ml intravenous in 6 hours.
Intervention Type
Drug
Intervention Name(s)
Magnesium sulphate
Intervention Description
Magnesium sulphate 2g diluted with 5%D/W into 20 ml solution, intravenous infusion in 10 min then Magnesium sulphate 6g diluted with 5%D/W into 100 ml solution, intravenous infusion in 6 hours.
Primary Outcome Measure Information:
Title
Rate of conversion to sinus rhythm and/or ventricular rate less than 120 beats per min
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Blood pressure, superior vena cava or mixed venous oxygen saturation, cardiac index, inotropic and vasopressors dosage
Time Frame
6 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Admitted in medical intensive care unit
Age 18 years or more
New onset atrial fibrillation (within 48 hours), persist for at least 1 hour, ventricular rate 120 beats per min or more without evidence of volume depletion (CVP 8 mmHg or more or receive volume resuscitation about 20-30 ml/kg), oxygen saturation not less than 90%, serum Potassium level between 3.0-5.0 mEq/l, serum Calcium level between 8.0-11.0 mg/dl
Exclusion Criteria:
Chronic atrial fibrillation
Severe valvular heart disease including severe mitral regurgitation, mitral stenosis, aortic regurgitation, aortic stenosis, tricuspid regurgitation, tricuspid stenosis, pulmonic regurgitation or pulmonic stenosis
Indicated for electrical cardioversion
Severe hypomagnesemia (serum Magnesium < 1.2 mg/dl)
Severe hypermagnesemia (serum Magnesium > 5.0 mg/dl)
Renal insufficiency with creatinine > 3.0 mg/dl without renal replacement therapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Surat Tongyoo, MD
Phone
6624198534
Email
surat_Ty@yahoo.co.uk
Facility Information:
Facility Name
Faculty of Medicine, Siriraj Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Surat Tongyoo, MD
Phone
6624198534
Email
surat_Ty@yahoo.co.uk
12. IPD Sharing Statement
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Magnesium Sulphate for Treatment of New Onset Atrial Fibrillation in Medical Intensive Care Unit Patient
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