Q10 Preloading Before Cardiac Surgery for Kidney Failure Reduction

NCT ID: NCT04445779

Last Updated: 2020-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-15

Study Completion Date

2021-12-31

Brief Summary

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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

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Conditions

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Acute Kidney Injury Acute Kidney Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Coenzyme Q10

Intervention Type 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.

Placebo

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

Group Type PLACEBO_COMPARATOR

Coenzyme Q10

Intervention Type 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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinical Hospital Center, Split

OTHER

Sponsor Role lead

Responsible Party

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Hrvoje Vučemilović

Hrvoje Vučemilović, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clinical Hospital Center Split

Split, Split-Dalmatia County, Croatia

Site Status RECRUITING

Countries

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Croatia

Central Contacts

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Hrvoje Vučemilović, MD

Role: CONTACT

00385914444032

Facility Contacts

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Hrvoje Vučemilović, MD

Role: primary

00 385 91 4444 032

Other Identifiers

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28878529

Identifier Type: -

Identifier Source: org_study_id

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