Acute Kidney Failure, Acute Kidney Injury
Conditions
Brief summary
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).
Interventions
DIETARY_SUPPLEMENTCoenzyme Q10
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.
Sponsors
Clinical Hospital Center, Split
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in serum creatinine after cardiac surgery indicating kidney injury. | 7 days | Increase in serum creatinine as defined by KDIGO stages will be used as indicator of kidney injury. |
| Difference in urinary low molekular weight alpha 1 microglobulin as an indicator of kidney tubular injury. | 3 days | Alpha 1 microglobulin is an indicator of kidney tubular damage, measured in urine. |
| Daily urine output during the 72 hours postoperatively. | 3 days | Urine output less than 0.5 ml/kg/h during 6 hours indicates increased risk of developing AKI. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of stay in intensive care unit | 10 days | Length of stay in intensive care unit will be compared between an intervention and placebo arm of trial. |
| Advanced glycation endproducts | 7 days | 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. |
Countries
Croatia
Contacts
Primary ContactHrvoje Vučemilović, MD
Outcome results
None listed