The Effect of Magnesium Therapy to Prevent Post-operative Atrial Fibrillation After Cardiac Surgery in Adults
1 other identifier
interventional
40
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable atrial-fibrillation
Started Aug 2015
Shorter than P25 for not_applicable atrial-fibrillation
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 7, 2016
CompletedFirst Posted
Study publicly available on registry
October 10, 2016
CompletedOctober 10, 2016
October 1, 2016
1 year
October 7, 2016
October 7, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Atrial fibrillation
the incidence of postoperative atrial fibrillation
3 post operative days
Study Arms (2)
magnesium
ACTIVE COMPARATORFive 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 COMPARATOR100 ml of normal saline solution infused intravenously over 4 hours once daily , for 3 days
Interventions
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.
100 ml of saline solution infused intravenously over 4 hours, once daily for 3 days starting when the patient is shifted to ICU.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- history of AF,
- implanted pacemaker,
- postoperative myocardial infarction,
- use of left ventricular assist devices
- Renal failure or on hemodialysis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Emad Zarief Kamel Said
Asyut, Asyut Governorate, 71111, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of Anesthesia and critical care Medicine
Study Record Dates
First Submitted
October 7, 2016
First Posted
October 10, 2016
Study Start
August 1, 2015
Primary Completion
August 1, 2016
Study Completion
October 1, 2016
Last Updated
October 10, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will share