Antiarrhythmic and Cardioprotective Effects of Atorvastatin Versus Magnesium Sulfate in Cardiac Valve Replacement Surgery
NCT ID: NCT03289429
Last Updated: 2018-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
96 participants
INTERVENTIONAL
2017-09-24
2018-02-28
Brief Summary
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Detailed Description
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Statin is used commonly for its lipid lowering action, however, some studies shows that statin has powerful pleiotropic effects including its antiarrhythmic effect.
This study aims to compare the antiarrhythmic and cardioprotective effects of Atorvastatin versus magnesium sulfate after cardiac replacement surgery.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Atorvastatin
Atorvastatin and intravenous placebo
Atorvastatin
Atorvastatin in a dose of 80 mgs, twelve hours preoperatively, two hours preoperatively, and on the 2nd, 3rd, 4th and 5th postoperative days.
intravenous placebo
100 mL of isotonic saline (to be infused over 2 hours) twelve hours preoperatively, within the first hour of ICU arrival, and on the 2nd and 3rd postoperative days.
Magnesium sulfate
Magnesium sulfate and tablets placebo
Magnesium Sulfate
Magnesium sulfate: ( 3 grams dissolved in 100 mL of isotonic saline to be infused over 2 hours) twelve hours preoperatively, within the first hour of ICU arrival, and on the 2nd and 3rd postoperative days.
tablets placebo
Placebo tablets: twelve hours preoperatively, two hours preoperatively, and on the 2nd, 3rd, 4th and 5th postoperative days.
Control
intravenous placebo and tablet placebo
intravenous placebo
100 mL of isotonic saline (to be infused over 2 hours) twelve hours preoperatively, within the first hour of ICU arrival, and on the 2nd and 3rd postoperative days.
tablets placebo
Placebo tablets: twelve hours preoperatively, two hours preoperatively, and on the 2nd, 3rd, 4th and 5th postoperative days.
Interventions
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Atorvastatin
Atorvastatin in a dose of 80 mgs, twelve hours preoperatively, two hours preoperatively, and on the 2nd, 3rd, 4th and 5th postoperative days.
Magnesium Sulfate
Magnesium sulfate: ( 3 grams dissolved in 100 mL of isotonic saline to be infused over 2 hours) twelve hours preoperatively, within the first hour of ICU arrival, and on the 2nd and 3rd postoperative days.
intravenous placebo
100 mL of isotonic saline (to be infused over 2 hours) twelve hours preoperatively, within the first hour of ICU arrival, and on the 2nd and 3rd postoperative days.
tablets placebo
Placebo tablets: twelve hours preoperatively, two hours preoperatively, and on the 2nd, 3rd, 4th and 5th postoperative days.
Eligibility Criteria
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Inclusion Criteria
* Preoperative rhythm: Sinus rhythm.
* Preoperative troponin I \< 0.01 ng/mL.
* Normal lipid profile.
* White blood cells (4-11 X 103/mm3).
* Preoperative C-reactive protein \< 3 mg/L.
Exclusion Criteria
* Any degree of heart block or patients with implanted pacemaker.
* Prior use of Antiarrhythmic drugs.
* Preoperative lipid lowering therapy (e.g statins) during the last 3 months.
* Previous treatment with any type of magnesium containing supplementation (the week before the intervention).
* Underlying heart failure or Left ventricular ejection fraction \< 0.3.
* Previous myocardial infarction.
* Diabetes or other metabolic disorders.
* Renal diseases.
* Hepatic dysfunction.
* Underlying thyroid problems (hypo/hyperthyroidism).
* Underlying inflammatory disease (active or controlled)
* Immunosuppressive and anti-inflammatory medications for the treatment of coexisting conditions.
* Psychological disorders,
* Emergency cardiac surgery
18 Years
50 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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FATMA NABIL AHMED MOHAMED
Assistant lecturer of anesthesia and intensive care, Assiut University
Locations
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Assiut University
Asyut, , Egypt
Countries
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Facility Contacts
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Other Identifiers
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Statin and Magnesium
Identifier Type: -
Identifier Source: org_study_id
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