About this trial
Lay Summary
This study tests two ways of measuring blood magnesium after heart surgery. Children who need heart surgery may have heart and kidney problems after surgery. The right amount of magnesium in blood reduces this risk. This study will test the best way to measure magnesium. This will let doctors choose the right dose of MgSO4. MgSO4 is a magnesium supplement. Taking MgSO4 after heart surgery helps children. For each child, it is best to personalize MgSO4 dose. This is based on the amount of magnesium in blood. This study will test two ways of personalizing MgSO4 dose.
In the blood, there are two kinds of magnesium. Usually, blood magnesium tests measure both forms together. This does not say anything about active magnesium. This study will measure the two forms separately. Then, MgSO4 will be given based on either the active or whole magnesium. Measuring active magnesium is good. Active magnesium levels change faster than total. That means active magnesium tests may better protect children. Also, active magnesium has more of an impact on heart and kidney function. Focusing on the active form will help these organs stay healthy.
To test how well the MgSO4 is working, heart and kidneys will be examined. After surgery, certain harmful heart rhythms can occur. The types and number of harmful rhythms will be studied. Kidney problems can also happen after heart surgery. Kidney health will be studied. To help understand how active magnesium works, further tests will be done. These tests will look for evidence of poor health in the cells that make up the heart, kidney, and blood.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children undergoing cardiac surgery utilizing cardiopulmonary bypass
Disqualifiers
Children undergoing cardiac surgery without cardiopulmonary bypass
Children with Renal disease
Children with pre-existing arrhythmia
Children on anti-arrhythmia medication
Trial design
Parallel
Treatments tested in this trial
total magnesium
Diagnostic testTreatment based on total Magnesium
ionized magnesium
DeviceTreatment based on ionized magnesium
Treatment groups
Trial outcomes
Primary outcomes
Duration from reanimation to sinus rhythm
Time in non-sinus rhythms: within 24h of removing aortic cross-clamp
Time in non-sinus rhythms: 24-48h after removing aortic cross-clamp
Presence of any arrhythmia
Defined as any non-sinus rhythm
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: