Q10 Preloading Before Cardiac Surgery for Kidney Failure Reduction (PREKARKID-10)

Clinical Hospital Center, Split

Status

Unknown

Conditions

Acute Kidney Failure

Acute Kidney Injury

Treatments

Dietary Supplement: Coenzyme Q10

Study type

Interventional

Funder types

Other

Identifiers

NCT04445779

28878529

Details and patient eligibility

About

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).

Enrollment

100 estimated patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

100 participants in 2 patient groups, including a placebo group

CoQ10

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Coenzyme Q10

Placebo

Placebo Comparator group

Description:

Patients will receive per-orally placebo in three divided doses.

Treatment:

Dietary Supplement: Coenzyme Q10