Acute Kidney InjuryPREKARKID-10NCT04445779
Q10 Preloading Before Cardiac Surgery for Kidney Failure Reduction
A study testing Coenzyme Q10 in people with Acute Kidney Injury and Acute Kidney Failure, run by Clinical Hospital Center, Split at 1 site in Croatia.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Acute Kidney Injury, Acute Kidney Failure
- What is being tested?
- Coenzyme Q10
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteCroatia
- Study dates
- 15 Jul 2020to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients scheduled for elective cardiac surgery
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
Clinical Hospital Center Split
Split, Split-Dalmatia County, 21000
Hrvoje Vučemilović, MD, 00 385 91 4444 032, hrvoje.vucemilovic@gmail.com
About this study
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
- Being tested
- Coenzyme Q10
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coenzyme Q10Dietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Coenzyme Q10 |
| Placebo | Placebo comparator | Patients will receive per-orally placebo in three divided doses. Receives: Dietary Supplement: Coenzyme Q10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 3 days
Secondary outcomes (2)
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.
Measured: 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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start15 Jul 2020 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Hospital Center, Split
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hrvoje Vučemilović, Clinical Hospital Center, Split
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04445779
- Sponsor's protocol ID
- 28878529
- Acronym
- PREKARKID-10
- Status last verified
- Jul 2020
- First submitted
- 5 Jun 2020
- Last updated
- 16 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Q10 Preloading Before Cardiac Surgery for Kidney Failure Reduction
- ClinicalTrials.gov ID
- NCT04445779
- Acronym / sponsor ID
- PREKARKID-10 / 28878529
- Conditions
- Acute Kidney Injury, Acute Kidney Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Clinical Hospital Center, SplitUniversity, hospital or other
- Study start
- 15 Jul 2020 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 24 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CoQ10 | Experimental | Dietary Supplement: Coenzyme Q10Patients 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 | Placebo comparator | Dietary Supplement: Coenzyme Q10Patients will receive per-orally placebo in three divided doses. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients scheduled for elective cardiac surgery
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coenzyme Q10Patients 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. | Dietary supplement | CoQ10, Placebo |
Primary outcome
Difference in serum creatinine after cardiac surgery indicating kidney injury.
Time frame: 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.
Time frame: 3 days
Alpha 1 microglobulin is an indicator of kidney tubular damage, measured in urine.
Daily urine output during the 72 hours postoperatively.
Time frame: 3 days
Urine output less than 0.5 ml/kg/h during 6 hours indicates increased risk of developing AKI.
2 secondary outcomes
Length of stay in intensive care unit
Time frame: 10 days
Advanced glycation endproducts
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coenzyme Q10 in people with Acute Kidney Injury and Acute Kidney Failure, run by Clinical Hospital Center, Split at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hrvoje Vučemilović, MD (00385914444032, hrvoje.vucemilovic@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in serum creatinine after cardiac surgery indicating kidney injury. (time frame: 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2020; AzTrials last refreshed its copy on 28 Oct 2026.