Q10 Preloading Before Cardiac Surgery for Kidney Failure Reduction

NCT04445779 | Unknown

• 1 other identifier: 28878529
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Acute Kidney Injury; Acute Kidney Failure

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Length of stay in intensive care unit

  10 days

• Advanced glycation endproducts

  7 days

Study Arms (2)

CoQ10

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Coenzyme Q10

Interventions

Coenzyme Q10 DIETARY_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.

CoQ10; Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients scheduled for elective cardiac surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinical Hospital Center, Split: lead

Study Sites (1)

Clinical Hospital Center Split

Split, Split-Dalmatia County, 21000, Croatia

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

coenzyme Q10

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Hrvoje Vučemilović, MD

CONTACT

00385914444032; hrvoje.vucemilovic@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hrvoje Vučemilović, Principal Investigator

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: June 24, 2020
• Study Start: July 15, 2020
• Primary Completion: September 1, 2021
• Study Completion: December 1, 2021
• Last Updated: July 16, 2020

Record last verified: 2020-07

Locations

CR (1)