Atrial FibrillationNCT02928315
The Effect of Magnesium Therapy to Prevent Post-operative Atrial Fibrillation After Cardiac Surgery in Adults
A study testing Magnesium Sulfate in people with Atrial Fibrillation, run by Assiut University at 1 site in Egypt.
Trial summary
It is well known that magnesium sulfate has a membrane stabilizing effect , and broad spectrum anti arrhythmic properties. In this trial, the investigators study its prophylactic effect against atrial fibrillation in postoperative period of cardiac surgery. 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 Sulfate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2015to Oct 2016
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients over 18 years.
- Left ventricular ejection fraction >0.3,
- Blood pressure is normal or less than 180/110.
- ASA ≤ III.
- Normal liver, pulmonary and renal function,
- No diabetes or other metabolism disorders,
- No pulmonary hypertension,
- No atrial fibrillation in the past, sinus rhythm on preoperative electrocardiogram.
Who cannot join
- history of AF,
- implanted pacemaker,
- postoperative myocardial infarction,
- use of left ventricular assist devices
- Renal failure or on hemodialysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Magnesium Therapy to Prevent Post-operative Atrial Fibrillation After Cardiac Surgery in Adults, Concerning the Perioperative Changes in Serum Electrolytes
It is well known that magnesium sulfate has a membrane stabilizing effect , and broad spectrum anti arrhythmic properties. In this trial, the investigators study its prophylactic effect against atrial fibrillation in postoperative period of cardiac surgery.
Read the detailed description
One of the most common postoperative complications after cardiac surgery is postoperative atrial fibrillation (AF). It is rarely fatal but it may cause subjective symptoms and result in thromboembolic complications, heart failure, renal insufficiency, and stroke which may prolong hospital stay.
The risk factors of AF include advanced age, transient atrial ischemia, arterial hypertension, dilated atria, male sex, pulmonary hypertension, previous atrial fibrillation and serum electrolyte disorders . On the other hand, there is evidence that cardiopulmonary bypass (CPB) time, duration of aortic cross clamping and the time of surgery, also the type of cardioplegia and the number of constructed grafts do not influence the incidence of AF.
There are only few studies that show the depletion of electrolytes and serum electrolyte concentration changes after cardiac surgery . The role of potassium in pathogenesis of cardiac arrhythmias is well recognized. Low serum potassium level is often found in association with hypomagnesemia and predisposes to atrial fibrillation. Extracellular magnesium is broadly implicated in neuronal control, neuromuscular transmission, and cardiovascular tone. It has been shown that magnesium suppresses arrhythmias after acute myocardial infarction, and there are studies confirming correlation between hypomagnesemia and postoperative atrial fibrillation . The underlying mechanism of these effects is not well understood but most probably involves magnesium interaction with calcium channels within myocytes membrane. Still the role of magnesium in the pathogenesis of AF is not clear yet.
Also, it is not clear if magnesium supplementation is useful for these patients, or it is useful only in hypomagnesemia patients. Hypophosphatemia and its consequences are less investigated in patients after cardiac surgery. Common complications after cardiac surgery are cardiac and respiratory failure, and they are also among the clinical manifestations of hypophosphatemia. Hypophosphatemia could be the cause of prolonged artificial lung ventilation and myocardial dysfunction; also, it may have influence on the incidence of arrhythmias. Anyway, there are no data confirming the arrhythmogenic effect of changes in serum phosphate level.
- Conditions
- Atrial Fibrillation
- Being tested
- Magnesium Sulfate, control
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium SulfateDrug
The patients in the study group will receive 10 mmol of magnesium sulphate (2.47 gm). Five ampoules of 500 mg of magnesium sulphate will be dissolved in 100 ml of saline solution infused intravenously over 4 hours, once daily for 3 days starting when the patient is shifted to ICU.
controlOther
100 ml of saline solution infused intravenously over 4 hours, once daily for 3 days starting when the patient is shifted to ICU.
| Study group | Role | What they receive |
|---|---|---|
| magnesium | Active comparator | Five ampules of 500 mg of magnesium sulfate will be dissolved in 100 ml of normal saline solution infused intravenously over 4 hours, once daily for 3 days starting when the patient is shifted to ICU. Receives: Drug: Magnesium Sulfate |
| control | Placebo comparator | 100 ml of normal saline solution infused intravenously over 4 hours once daily , for 3 days Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial fibrillation
the incidence of postoperative atrial fibrillation
Measured: 3 post operative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2016 (estimated)
- Study startAug 2015
- Primary completionAug 2016
- Study completionOct 2016
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 Assiut 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emad Zarief , MD, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02928315
- Sponsor's protocol ID
- IRB00009907
- Status last verified
- Oct 2016
- First submitted
- 7 Oct 2016
- Last updated
- 10 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Magnesium Therapy to Prevent Post-operative Atrial Fibrillation After Cardiac Surgery in Adults, Concerning the Perioperative Changes in Serum Electrolytes
- ClinicalTrials.gov ID
- NCT02928315
- Acronym / sponsor ID
- IRB00009907
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 10 Oct 2016 (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.
It is well known that magnesium sulfate has a membrane stabilizing effect , and broad spectrum anti arrhythmic properties. In this trial, the investigators study its prophylactic effect against atrial fibrillation in postoperative period of cardiac surgery.
Detailed description
One of the most common postoperative complications after cardiac surgery is postoperative atrial fibrillation (AF). It is rarely fatal but it may cause subjective symptoms and result in thromboembolic complications, heart failure, renal insufficiency, and stroke which may prolong hospital stay.
The risk factors of AF include advanced age, transient atrial ischemia, arterial hypertension, dilated atria, male sex, pulmonary hypertension, previous atrial fibrillation and serum electrolyte disorders . On the other hand, there is evidence that cardiopulmonary bypass (CPB) time, duration of aortic cross clamping and the time of surgery, also the type of cardioplegia and the number of constructed grafts do not influence the incidence of AF.
There are only few studies that show the depletion of electrolytes and serum electrolyte concentration changes after cardiac surgery . The role of potassium in pathogenesis of cardiac arrhythmias is well recognized. Low serum potassium level is often found in association with hypomagnesemia and predisposes to atrial fibrillation. Extracellular magnesium is broadly implicated in neuronal control, neuromuscular transmission, and cardiovascular tone. It has been shown that magnesium suppresses arrhythmias after acute myocardial infarction, and there are studies confirming correlation between hypomagnesemia and postoperative atrial fibrillation . The underlying mechanism of these effects is not well understood but most probably involves magnesium interaction with calcium channels within myocytes membrane. Still the role of magnesium in the pathogenesis of AF is not clear yet.
Also, it is not clear if magnesium supplementation is useful for these patients, or it is useful only in hypomagnesemia patients. Hypophosphatemia and its consequences are less investigated in patients after cardiac surgery. Common complications after cardiac surgery are cardiac and respiratory failure, and they are also among the clinical manifestations of hypophosphatemia. Hypophosphatemia could be the cause of prolonged artificial lung ventilation and myocardial dysfunction; also, it may have influence on the incidence of arrhythmias. Anyway, there are no data confirming the arrhythmogenic effect of changes in serum phosphate level.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| magnesium | Active comparator | Drug: Magnesium SulfateFive ampules of 500 mg of magnesium sulfate will be dissolved in 100 ml of normal saline solution infused intravenously over 4 hours, once daily for 3 days starting when the patient is shifted to ICU. |
| control | Placebo comparator | Other: control100 ml of normal saline solution infused intravenously over 4 hours once daily , for 3 days |
Who may qualify
- Ages
- 18 years and older
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult patients over 18 years.
- Left ventricular ejection fraction >0.3,
- Blood pressure is normal or less than 180/110.
- ASA ≤ III.
- Normal liver, pulmonary and renal function,
Key exclusion criteria (5 listed)
- history of AF,
- implanted pacemaker,
- postoperative myocardial infarction,
- use of left ventricular assist devices
- Renal failure or on hemodialysis
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 |
|---|---|---|
| Magnesium SulfateThe patients in the study group will receive 10 mmol of magnesium sulphate (2.47 gm). Five ampoules of 500 mg of magnesium sulphate will be dissolved in 100 ml of saline solution infused intravenously over 4 hours, once daily for 3 days starting when the patient is shifted to ICU. | Drug | magnesium |
| control100 ml of saline solution infused intravenously over 4 hours, once daily for 3 days starting when the patient is shifted to ICU. | Other | control |
Primary outcome
Atrial fibrillation
Time frame: 3 post operative days
the incidence of postoperative atrial fibrillation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2016.
- Individual participant dataSharing planned: Yes
Related trials for Atrial Fibrillation
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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CONVERGE Post-Approval Study (PAS)
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Atrial Fibrillation (AF)
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Sulfate in people with Atrial Fibrillation, run by Assiut University at 1 site in Egypt.
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 8 inclusion and 5 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: finished, as of the sponsor's last update on 10 Oct 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial fibrillation (time frame: 3 post operative days). 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 10 Oct 2016.