Magnesium Sulphate for Treatment of New Onset Atrial Fibrillation in Medical Intensive Care Unit Patient (EMSAF)

This study is currently recruiting participants.
Verified May 2013 by Mahidol University
Sponsor:
Information provided by (Responsible Party):
Surat Tongyoo, Mahidol University
ClinicalTrials.gov Identifier:
NCT01049464
First received: January 13, 2010
Last updated: May 1, 2013
Last verified: May 2013

January 13, 2010
May 1, 2013
January 2010
December 2013   (final data collection date for primary outcome measure)
Rate of conversion to sinus rhythm and/or ventricular rate less than 120 beats per min [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01049464 on ClinicalTrials.gov Archive Site
Blood pressure, superior vena cava or mixed venous oxygen saturation, cardiac index, inotropic and vasopressors dosage [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Magnesium Sulphate for Treatment of New Onset Atrial Fibrillation in Medical Intensive Care Unit Patient
Efficacy of Magnesium Sulphate for Rate and Rhythm Control of New-onset Atrial Fibrillation in the Medical Critically Ill Patients: A Randomized, Controlled Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Atrial Fibrillation
  • Drug: Placebo
    5%D/W 20 ml intravenous in 10 min then 5%D/W 100 ml intravenous in 6 hours.
    Other Name: 5%D/W
  • Drug: Magnesium sulphate
    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.
  • 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.
    Intervention: Drug: Placebo
  • 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
    Intervention: Drug: Magnesium sulphate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
128
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Surat Tongyoo, MD 6624198534 surat_Ty@yahoo.co.uk
Thailand
 
NCT01049464
Si628/2009
No
Surat Tongyoo, Mahidol University
Mahidol University
Not Provided
Not Provided
Mahidol University
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP