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

Sponsors

Lead Sponsor: Mahidol University

Source Mahidol University
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.

Overall Status Unknown status
Start Date January 2010
Completion Date January 2018
Primary Completion Date December 2017
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Rate of conversion to sinus rhythm and/or ventricular rate less than 120 beats per min 6 hours
Secondary Outcome
Measure Time Frame
Blood pressure, superior vena cava or mixed venous oxygen saturation, cardiac index, inotropic and vasopressors dosage 6 hours
Enrollment 128
Condition
Intervention

Intervention Type: Drug

Intervention Name: Placebo

Description: 5%D/W 20 ml intravenous in 10 min then 5%D/W 100 ml intravenous in 6 hours.

Arm Group Label: 5%D/W

Other Name: 5%D/W

Intervention Type: Drug

Intervention Name: Magnesium sulphate

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.

Arm Group Label: Magnesium sulphate

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Last Name: Surat Tongyoo, MD

Phone: 6624198534

Email: [email protected]

Location
Facility: Status: Contact: Faculty of Medicine, Siriraj Hospital, Mahidol University Surat Tongyoo, MD 6624198534 [email protected]
Location Countries

Thailand

Verification Date

March 2016

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Mahidol University

Investigator Full Name: Surat Tongyoo

Investigator Title: Dr.

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: 5%D/W

Type: Placebo Comparator

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.

Label: Magnesium sulphate

Type: Experimental

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

Acronym EMSAF
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov