## Protocol Section
### Identification Module
**NCT ID:** NCT04445779

**Acronym:** PREKARKID-10

**Brief Title:** Q10 Preloading Before Cardiac Surgery for Kidney Failure Reduction

**Official Title:** Q10 Preloading Before Cardiac Surgery for Kidney Failure Reduction

#### Organization Study ID Info
**ID:** 28878529
#### Organization
**Class:** OTHER
**Full Name:** Clinical Hospital Center, Split
### Status Module
#### Completion Date
**Date:** 2021-12

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2020-07-16

**Type:** ACTUAL

**Last Update Submit Date:** 2020-07-14

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2021-09

**Type:** ESTIMATED

#### Start Date
**Date:** 2020-07-15

**Type:** ESTIMATED

**Status Verified Date:** 2020-07

#### Study First Post Date
**Date:** 2020-06-24
**Type:** ACTUAL
**Study First Submit Date:** 2020-06-05
**Study First Submit QC Date:** 2020-06-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Clinical Hospital Center, Split

#### Responsible Party

**Investigator Affiliation:** Clinical Hospital Center, Split

**Investigator Full Name:** Hrvoje Vučemilović

**Investigator Title:** Hrvoje Vučemilović, Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Acute Kidney Injury

- Acute Kidney Failure

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 100

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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.

**Intervention Names:**

- Dietary Supplement: Coenzyme Q10

**Label:** CoQ10

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Dietary Supplement: Coenzyme Q10

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- CoQ10

- Placebo

**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.

**Name:** Coenzyme Q10

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Primary Outcomes

**Description:** Increase in serum creatinine as defined by KDIGO stages will be used as indicator of kidney injury.

**Measure:** Difference in serum creatinine after cardiac surgery indicating kidney injury.

**Time Frame:** 7 days

**Description:** Alpha 1 microglobulin is an indicator of kidney tubular damage, measured in urine.

**Measure:** Difference in urinary low molekular weight alpha 1 microglobulin as an indicator of kidney tubular injury.

**Time Frame:** 3 days

**Description:** Urine output less than 0.5 ml/kg/h during 6 hours indicates increased risk of developing AKI.

**Measure:** Daily urine output during the 72 hours postoperatively.

**Time Frame:** 3 days

#### Secondary Outcomes

**Description:** Length of stay in intensive care unit will be compared between an intervention and placebo arm of trial.

**Measure:** Length of stay in intensive care unit

**Time Frame:** 10 days

**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.

**Measure:** Advanced glycation endproducts

**Time Frame:** 7 days

### Eligibility Module

**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

**Minimum Age:** 40 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** hrvoje.vucemilovic@gmail.com

**Name:** Hrvoje Vučemilović, MD

**Phone:** 00385914444032

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Split

**Contacts:**

***Contact 1:***

- **Email:** hrvoje.vucemilovic@gmail.com

- **Name:** Hrvoje Vučemilović, MD

- **Phone:** 00 385 91 4444 032

- **Role:** CONTACT

**Country:** Croatia

**Facility:** Clinical Hospital Center Split

**State:** Splitsko Dalmatinska Županija

**Status:** RECRUITING

**Zip:** 21000

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007674

- Term: Kidney Diseases

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M28998

- Name: Acute Kidney Injury

- Relevance: HIGH

- As Found: Acute Kidney Injury

- ID: M26718

- Name: Renal Insufficiency

- Relevance: HIGH

- As Found: Kidney Failure

- ID: M10698

- Name: Kidney Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000058186

- Term: Acute Kidney Injury

- ID: D000051437

- Term: Renal Insufficiency

### Intervention Browse Module - Ancestors

- ID: D000018977

- Term: Micronutrients

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000014815

- Term: Vitamins

### Intervention Browse Module - Browse Branches

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Ot

- Name: Other Dietary Supplements

### Intervention Browse Module - Browse Leaves

- ID: M271049

- Name: Coenzyme Q10

- Relevance: HIGH

- As Found: Micronutrient

- ID: M17201

- Name: Ubiquinone

- Relevance: HIGH

- As Found: Vacuum

- ID: M21009

- Name: Micronutrients

- Relevance: LOW

- As Found: Unknown

- ID: M16885

- Name: Trace Elements

- Relevance: LOW

- As Found: Unknown

- ID: M17558

- Name: Vitamins

- Relevance: LOW

- As Found: Unknown

- ID: T383

- Name: Coenzyme Q10

- Relevance: HIGH

- As Found: Micronutrient

### Intervention Browse Module - Meshes

- ID: D000014451

- Term: Ubiquinone

- ID: C000024989

- Term: Coenzyme Q10

### Misc Info Module

- Version Holder: 2024-05-24
