Q10 Preloading Before Cardiac Surgery for Kidney Failure Reduction

Acute Kidney Injury Clinical Trial

— PREKARKID-10  

Official title:

Q10 Preloading Before Cardiac Surgery for Kidney Failure Reduction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04445779
• Other study ID #: 28878529
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2020
• Est. completion date: December 2021

Study information

• Verified date: July 2020
• Source: Clinical Hospital Center, Split
• Contact: Hrvoje Vucemilovic, MD
• Phone: 00385914444032
• Email: hrvoje.vucemilovic[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Failure
• Acute Kidney Injury
• Renal Insufficiency

Intervention

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.

Locations

Country	Name	City	State
Croatia	Clinical Hospital Center Split	Split	Splitsko Dalmatinska Županija

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Hospital Center, Split

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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