Q10 Preloading Before Cardiac Surgery for Kidney Failure Reduction
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Difference in serum creatinine after cardiac surgery indicating kidney injury.
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Placebo
Patients will receive per-orally placebo in three divided doses.
Intervention: Coenzyme Q10 (Dietary Supplement)
CoQ10
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.
Intervention: Coenzyme Q10 (Dietary Supplement)
Outcomes
Primary Outcomes
Difference in serum creatinine after cardiac surgery indicating kidney injury.
Time Frame: 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.
Time Frame: 3 days
Alpha 1 microglobulin is an indicator of kidney tubular damage, measured in urine.
Daily urine output during the 72 hours postoperatively.
Time Frame: 3 days
Urine output less than 0.5 ml/kg/h during 6 hours indicates increased risk of developing AKI.
Secondary Outcomes
- Advanced glycation endproducts(7 days)
- Length of stay in intensive care unit(10 days)
Investigators
Hrvoje Vučemilović
Hrvoje Vučemilović, Principal Investigator
Clinical Hospital Center, Split