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

NCT01049464 | Unknown

• 1 other identifier: Si628/2009
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation; Hemodynamically unstable patients; Magnesium sulfate; Septic shock; Medical intensive care unit; New onset atrial fibrillation; Critically ill patients

Outcome Measures

Primary Outcomes (1)

• Rate of conversion to sinus rhythm and/or ventricular rate less than 120 beats per min

  6 hours

Secondary Outcomes (1)

• Blood pressure, superior vena cava or mixed venous oxygen saturation, cardiac index, inotropic and vasopressors dosage

  6 hours

Study Arms (2)

5%D/W

PLACEBO COMPARATOR

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.

Drug: Placebo

Magnesium sulphate

EXPERIMENTAL

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

Drug: Magnesium sulphate

Interventions

Placebo DRUG

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

Also known as: 5%D/W

5%D/W

Magnesium sulphate 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.

Magnesium sulphate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Medicine, Siriraj Hospital, Mahidol University

Bangkok, Bangkok, 10700, Thailand

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Shock, Septic

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Shock

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Central Study Contacts

Surat Tongyoo, MD

CONTACT

6624198534; surat_Ty@yahoo.co.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: January 13, 2010
• First Posted: January 14, 2010
• Study Start: January 1, 2010
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2018
• Last Updated: March 29, 2016

Record last verified: 2016-03

Locations

TH (1)