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

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 Overview

• Status: Unknown
• Conditions: Acute Kidney Injury; Acute Kidney Failure
• Intervention / Treatment: Dietary supplement: Coenzyme Q10

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Croatia
  • Splitsko Dalmatinska Županija
    • Split, Splitsko Dalmatinska Županija, Croatia, 21000
      • Recruiting
      • Clinical Hospital Center Split
      • Contact: Hrvoje Vučemilović, MD; Phone Number: 00 385 91 4444 032; Email: hrvoje.vucemilovic@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: Coenzyme 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.
Placebo Comparator: Placebo; Patients will receive per-orally placebo in three divided doses.	Dietary supplement: Coenzyme 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	7 days

Collaborators and Investigators

• Sponsor: Clinical Hospital Center, Split

Study record dates

Study Major Dates

• Study Start (Anticipated): July 15, 2020
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: June 5, 2020
• First Submitted That Met QC Criteria: June 21, 2020
• First Posted (Actual): June 24, 2020

Study Record Updates

• Last Update Posted (Actual): July 16, 2020
• Last Update Submitted That Met QC Criteria: July 14, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury; Physiological Effects of Drugs; Micronutrients; Vitamins; Coenzyme Q10; Ubiquinone
• Other Study ID Numbers: 28878529

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No