- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01049464
Magnesium Sulphate for Treatment of New Onset Atrial Fibrillation in Medical Intensive Care Unit Patient (EMSAF)
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bangkok, Thailand, 10700
- Recruiting
- Faculty of medicine, Siriraj hospital, Mahidol university
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 5%D/W
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.
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5%D/W 20 ml intravenous in 10 min then 5%D/W 100 ml intravenous in 6 hours.
Other Names:
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Experimental: Magnesium sulphate
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
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of conversion to sinus rhythm and/or ventricular rate less than 120 beats per min
Time Frame: 6 hours
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6 hours
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blood pressure, superior vena cava or mixed venous oxygen saturation, cardiac index, inotropic and vasopressors dosage
Time Frame: 6 hours
|
6 hours
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Arrhythmias, Cardiac
- Atrial Fibrillation
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Calcium Channel Blockers
- Tocolytic Agents
- Magnesium Sulfate
Other Study ID Numbers
- Si628/2009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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