Q10 Preloading Before Cardiac Surgery for Kidney Failure Reduction

Not Applicable

• Conditions: Acute Kidney Injury; Acute Kidney Failure
• Interventions: Dietary Supplement: Coenzyme Q10

• Registration Number: NCT04445779
• Lead Sponsor: Clinical Hospital Center, Split

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-05
• Study First Submitted QC: 2020-06-21
• Study First Posted: 2020-06-24
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-14
• Study Start: 2020-07-15
• Last Update Posted: 2020-07-16
• Primary Completion: 2021-09
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CoQ10	Coenzyme Q10	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.
Placebo	Coenzyme Q10	Patients will receive per-orally placebo in three divided doses.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Clinical Hospital Center Split; 🇭🇷 Split, Splitsko Dalmatinska Županija, Croatia