Back to resultsQ10 Preloading Before Cardiac Surgery for Kidney Failure Reduction (PREKARKID-10)
Primary Purpose
Acute Kidney Injury, Acute Kidney Failure
Status
Unknown status
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
Coenzyme Q10
Sponsored by
About this trial
This is an interventional prevention trial for Acute Kidney Injury
Eligibility Criteria
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
Sites / Locations
- Clinical Hospital Center SplitRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
CoQ10
Placebo
Arm Description
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.
Patients will receive per-orally placebo in three divided doses.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT04445779
First Posted
June 5, 2020
Last Updated
July 14, 2020
Sponsor
Clinical Hospital Center, Split
1. Study Identification
Unique Protocol Identification Number
NCT04445779
Brief Title
Q10 Preloading Before Cardiac Surgery for Kidney Failure Reduction
Acronym
PREKARKID-10
Official Title
Q10 Preloading Before Cardiac Surgery for Kidney Failure Reduction
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 15, 2020 (Anticipated)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinical Hospital Center, Split
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury, Acute Kidney Failure
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CoQ10
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will receive per-orally placebo in three divided doses.
Intervention Type
Dietary Supplement
Intervention Name(s)
Coenzyme Q10
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difference in serum creatinine after cardiac surgery indicating kidney injury.
Description
Increase in serum creatinine as defined by KDIGO stages will be used as indicator of kidney injury.
Time Frame
7 days
Title
Difference in urinary low molekular weight alpha 1 microglobulin as an indicator of kidney tubular injury.
Description
Alpha 1 microglobulin is an indicator of kidney tubular damage, measured in urine.
Time Frame
3 days
Title
Daily urine output during the 72 hours postoperatively.
Description
Urine output less than 0.5 ml/kg/h during 6 hours indicates increased risk of developing AKI.
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Length of stay in intensive care unit
Description
Length of stay in intensive care unit will be compared between an intervention and placebo arm of trial.
Time Frame
10 days
Title
Advanced glycation endproducts
Description
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.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hrvoje Vučemilović, MD
Phone
00385914444032
Email
hrvoje.vucemilovic@gmail.com
Facility Information:
Facility Name
Clinical Hospital Center Split
City
Split
State/Province
Splitsko Dalmatinska Županija
ZIP/Postal Code
21000
Country
Croatia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hrvoje Vučemilović, MD
Phone
00 385 91 4444 032
Email
hrvoje.vucemilovic@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Q10 Preloading Before Cardiac Surgery for Kidney Failure Reduction
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