Q10 Preloading Before Cardiac Surgery for Kidney Failure Reduction

Study Overview
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Brief Summary
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Coenzyme Q10 (CoQ10) is an essential molecule in human body. It acts as an antioxidant, a co-factor for energy conversion in mitochondria and has anti-inflammatory effects capable of improving endothelial function. Our goal is to investigate whether CoQ10 is capable to reduce the incidence of acute kidney injury/failure following cardiac surgery. Cardiac surgery is major risk factor for acute kidney injury/failure (AKI/F).

Official Title
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Q10 Preloading Before Cardiac Surgery for Kidney Failure Reduction

Conditions
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Acute Kidney Injury, Acute Kidney Failure

Intervention / Treatment
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* Dietary Supplement: Coenzyme Q10


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients scheduled for elective cardiac surgery Exclusion Criteria: patients receiving high dose vitamin B supplementation (defined as more that 200% of recommended daily allowances) patients under warfarin therapy urgent surgery end stage kidney disease therapy with multiple nephrotoxic drugs chronic kidney disease obstructive uropathy previous cardiac surgery procedure alcohol abuse malignancy allergy to any ingredient of Myoqinon capsule patients receiving Myoqinon and fail to demonstrate a significant increase in blood concentration of Q10 uncontrolled hypertension

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CoQ10<br>Patients will receive per-orally 10 mg/kg of body weight of coenzyme Q10 in the form of Myokinon (PharmaNord, Denmark) in three divided doses. They will receive therapy for at least 10 days before the surgical procedure. | Dietary Supplement: Coenzyme Q10<br>* Patients will receive per-orally 10 mg/kg of body weight of coenzyme Q10 in form of Myokinon (PharmaNord, Denmark) in three divided doses. They will receive therapy for at least 10 days before surgical procedure.<br>|
| Placebo Comparator: Placebo<br>Patients will receive per-orally placebo in three divided doses. | Dietary Supplement: Coenzyme Q10<br>* Patients will receive per-orally 10 mg/kg of body weight of coenzyme Q10 in form of Myokinon (PharmaNord, Denmark) in three divided doses. They will receive therapy for at least 10 days before surgical procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in serum creatinine after cardiac surgery indicating kidney injury. | Increase in serum creatinine as defined by KDIGO stages will be used as indicator of kidney injury. | 7 days | 
| Difference in urinary low molekular weight alpha 1 microglobulin as an indicator of kidney tubular injury. | Alpha 1 microglobulin is an indicator of kidney tubular damage, measured in urine. | 3 days | 
| Daily urine output during the 72 hours postoperatively. | Urine output less than 0.5 ml/kg/h during 6 hours indicates increased risk of developing AKI. | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay in intensive care unit | Length of stay in intensive care unit will be compared between an intervention and placebo arm of trial. | 10 days | 
| Advanced glycation endproducts | Elevated advanced glycation endproducts (AGE) in skin, measured using skin autofluorescence, are reliable predictors of cardiovascular disease and diabetes mellitus. Elevated levels before cardiac surgery should also predict increased risk of intraoperative morbidity, mortality and postoperative complications. | 7 days |