## Protocol Section
### Identification Module
**NCT ID:** NCT01886079

**Brief Title:** The Effects of Dexmedetomidine on Postoperative Renal Function in Valvular Heart Surgery

#### Organization Study ID Info
**ID:** 4-2013-0194
#### Organization
**Class:** OTHER
**Full Name:** Yonsei University
### Status Module
#### Completion Date
**Date:** 2015-05

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2013-06-25

**Type:** ESTIMATED

**Last Update Submit Date:** 2013-06-20

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2015-05

**Type:** ESTIMATED

#### Start Date
**Date:** 2013-05

**Status Verified Date:** 2013-06

#### Study First Post Date
**Date:** 2013-06-25
**Type:** ESTIMATED
**Study First Submit Date:** 2013-06-18
**Study First Submit QC Date:** 2013-06-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Yonsei University

#### Responsible Party

**Type:** SPONSOR

### Description Module

**Brief Summary:** The purpose of study is to compare the incidence of acute kidney injury in patients receiving perioperative dexmedetomidine or placebo undergoing valvular heart surgery.

### Conditions Module

**Conditions:**

- Acute Kidney Injury

### 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:** 200

**Type:** ESTIMATED

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: dexmedetomidine

**Label:** Dexmedetomidine group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Drug: Saline

**Label:** Saline group

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Dexmedetomidine group

**Description:** 0.4 mcg/kg/h, IV, The infusion of study drug is started after anesthesia induction and continued until 24 hours after surgery

**Name:** dexmedetomidine

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Saline group

**Description:** 0.4 mcg/kg/h, IV

**Name:** Saline

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** BUN/Creatinine, cystatin C, eGFR, urine output Incidence of acute kidney injury (based on the AKIN criteria)

**Measure:** Comparison of postoperative renal function in patients with or without dexmedetomidine undergoing valvular heart surgery:

**Time Frame:** 24 hours after surgery.

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* adult patients over the age of 20 scheduled for valvular heart surgery

Exclusion Criteria:

* Left ventricular-ejection fraction \< 30%
* Preexisting congestive heart failure
* Severe coronary artery disease
* Hemodynamically unstable arrhythmia
* Cardiogenic shock during perioperative period
* Ventricular assist device
* Severe renal dysfunction (eGFR \< 15ml/min per 1.73m2)

**Maximum Age:** 90 Years

**Minimum Age:** 20 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** SJW72331@yuhs.ac

**Name:** Jong Wook Song, MD

**Phone:** 82-2-2228-2420

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

**Status:** RECRUITING

**Zip:** 120-752

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000051437

- Term: Renal Insufficiency

- 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: LOW

- As Found: Unknown

- 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

### Intervention Browse Module - Ancestors

- ID: D000006993

- Term: Hypnotics and Sedatives

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018712

- Term: Analgesics, Non-Narcotic

- ID: D000000700

- Term: Analgesics

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000058647

- Term: Adrenergic alpha-2 Receptor Agonists

- ID: D000000316

- Term: Adrenergic alpha-Agonists

- ID: D000000322

- Term: Adrenergic Agonists

- ID: D000018663

- Term: Adrenergic Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: Analg

- Name: Analgesics

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M22662

- Name: Dexmedetomidine

- Relevance: HIGH

- As Found: Twice daily

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M10043

- Name: Hypnotics and Sedatives

- Relevance: LOW

- As Found: Unknown

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M20786

- Name: Analgesics, Non-Narcotic

- Relevance: LOW

- As Found: Unknown

- ID: M20746

- Name: Adrenergic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M3668

- Name: Adrenergic alpha-Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M3673

- Name: Adrenergic Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000020927

- Term: Dexmedetomidine

### Misc Info Module

- Version Holder: 2024-05-24
