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

NCT ID: NCT01049464

Last Updated: 2016-03-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2018-01-31

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

Magnesium sulphate

Intervention Type: DRUG

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.

Interventions

Placebo

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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

5%D/W

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Surat Tongyoo

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Medicine, Siriraj Hospital, Mahidol University

Bangkok, Bangkok, Thailand

Site Status: RECRUITING

Countries

Thailand

Central Contacts

Surat Tongyoo, MD

Role: CONTACT

surat_Ty@yahoo.co.uk

6624198534

Facility Contacts

Surat Tongyoo, MD

Role: primary

surat_Ty@yahoo.co.uk

6624198534

Other Identifiers

Si628/2009

Identifier Type: -

Identifier Source: org_study_id