Q10 Preloading Before Cardiac Surgery for Kidney Failure Reduction

Clinical Hospital Center, Split100 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

100

Conditions

Acute Kidney Injury Acute Kidney Failure

Interventions

Coenzyme Q10DIETARY_SUPPLEMENT

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.

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

Clinical Hospital Center Split

Split, Split-Dalmatia County, Croatia

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 3 days

Secondary Outcomes

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.

Time frame: 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.

Time frame: 7 days

Central Contacts

Hrvoje Vučemilović, MD

CONTACT

00385914444032 hrvoje.vucemilovic@gmail.com

Data from ClinicalTrials.gov

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