PREKARKID-10: Q10 Preloading Before Cardiac Surgery for Kidney Failure Reduction

Sponsor

Clinical Hospital Center, Split (Other)

Overall Status

Unknown status

CT.gov ID

NCT04445779

Collaborator

(none)

100

Enrollment

Location

Arms

16.6

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury Acute Kidney Failure	Dietary Supplement: Coenzyme Q10	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

Official Title:

Q10 Preloading Before Cardiac Surgery for Kidney Failure Reduction

Anticipated Study Start Date :

Jul 15, 2020

Anticipated Primary Completion Date :

Sep 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.
Placebo Comparator: Placebo Patients will receive per-orally placebo in three divided doses.	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.

Arm

Intervention/Treatment

Experimental: 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.

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.

Placebo Comparator: Placebo

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

Dietary Supplement: Coenzyme Q10

Outcome Measures

Primary Outcome Measures

Difference in serum creatinine after cardiac surgery indicating kidney injury. [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. [3 days]
Alpha 1 microglobulin is an indicator of kidney tubular damage, measured in urine.
Daily urine output during the 72 hours postoperatively. [3 days]
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 [10 days]
Length of stay in intensive care unit will be compared between an intervention and placebo arm of trial.
Advanced glycation endproducts [7 days]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Hospital Center Split	Split	Splitsko Dalmatinska Županija	Croatia	21000

Sponsors and Collaborators

Clinical Hospital Center, Split

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hrvoje Vučemilović, Hrvoje Vučemilović, Principal Investigator, Clinical Hospital Center, Split

ClinicalTrials.gov Identifier:

NCT04445779

Other Study ID Numbers:

28878529

First Posted:

Jun 24, 2020

Last Update Posted:

Jul 16, 2020

Last Verified:

Jul 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 16, 2020