Atrial FibrillationEMSAFNCT01049464
Magnesium Sulphate for Treatment of New Onset Atrial Fibrillation in Medical Intensive Care Unit Patient
A study testing Magnesium sulphate in people with Atrial Fibrillation, run by Mahidol University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Magnesium sulphate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2010to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Siriraj Hospital, Mahidol University
Bangkok, Bangkok, 10700
Surat Tongyoo, MD, 6624198534, surat_Ty@yahoo.co.uk
About this study
Official title: 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.
Read the 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
- Being tested
- Placebo, Magnesium sulphate
- Keywords
- Atrial fibrillation, Hemodynamically unstable patients, Magnesium sulfate, Septic shock, Medical intensive care unit, New onset atrial fibrillation, Critically ill patients
- Medical subject headings
- Atrial Fibrillation, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called 5%D/W
5%D/W 20 ml intravenous in 10 min then 5%D/W 100 ml intravenous in 6 hours.
Magnesium sulphateDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: Magnesium sulphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of conversion to sinus rhythm and/or ventricular rate less than 120 beats per min
Measured: 6 hours
Secondary outcomes (1)
Blood pressure, superior vena cava or mixed venous oxygen saturation, cardiac index, inotropic and vasopressors dosage
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionDec 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Surat Tongyoo, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01049464
- Sponsor's protocol ID
- Si628/2009
- Acronym
- EMSAF
- Status last verified
- Mar 2016
- First submitted
- 13 Jan 2010
- Last updated
- 29 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Magnesium Sulphate for Rate and Rhythm Control of New-onset Atrial Fibrillation in the Medical Critically Ill Patients: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT01049464
- Acronym / sponsor ID
- EMSAF / Si628/2009
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Hemodynamically unstable patients, Magnesium sulfate, Septic shock, Medical intensive care unit, New onset atrial fibrillation, Critically ill patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 14 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5%D/W | Placebo comparator | Drug: PlaceboThe 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. |
| Magnesium sulphate | Experimental | Drug: Magnesium sulphateThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboAlso: 5%D/W5%D/W 20 ml intravenous in 10 min then 5%D/W 100 ml intravenous in 6 hours. | Drug | 5%D/W |
| Magnesium sulphateMagnesium 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. | Drug | Magnesium sulphate |
Primary outcome
Rate of conversion to sinus rhythm and/or ventricular rate less than 120 beats per min
Time frame: 6 hours
1 secondary outcome
Blood pressure, superior vena cava or mixed venous oxygen saturation, cardiac index, inotropic and vasopressors dosage
Time frame: 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium sulphate in people with Atrial Fibrillation, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Surat Tongyoo, MD (6624198534, surat_Ty@yahoo.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of conversion to sinus rhythm and/or ventricular rate less than 120 beats per min (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2016.