## Protocol Section
### Identification Module
**NCT ID:** NCT00950079

**Brief Title:** Prevention of Contrast-Induced Nephropathy in Diabetic Patients With Undergoing Coronary Angiography

**Official Title:** Preventive Strategies of REnal Insufficiency in Patients With Diabetes Undergoing InterVENTion or Arteriography(PREVENT Trial)

#### Organization Study ID Info
**ID:** 2007-0180
#### Organization
**Class:** OTHER
**Full Name:** CardioVascular Research Foundation, Korea
### Status Module
#### Completion Date
**Date:** 2010-01

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2009-07-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2009-07-30

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2009-08

**Type:** ESTIMATED

#### Start Date
**Date:** 2008-02

**Status Verified Date:** 2009-07

#### Study First Post Date
**Date:** 2009-07-31
**Type:** ESTIMATED
**Study First Submit Date:** 2009-07-06
**Study First Submit QC Date:** 2009-07-30
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** CardioVascular Research Foundation, Korea

#### Responsible Party

**Old Name Title:** Seong-Wook Park, MD, PhD

**Old Organization:** Asan Medical Center

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The aim of this study is to determine whether sodium bicarbonate is superior to sodium chloride in preventing contrast induced nephropathy in diabetic patients undergoing coronary angiography or intervention.

**Detailed Description:** Contrast induced nephropathy (CIN) is a common cause of renal failure associated with prolonged hospitalization, significant morbidity or mortality, and cost. CIN has been reported to account for 10% of hospital acquired renal failure. Several strategies or medications were tried to prevent CIN. Of these, mucomyst and normal saline infusion are effective to prevent CIN. Sodium bicarbonate has shown mixed results from recent randomized trials. Moreover,limited data have been available for preventing CIN in diabetic renal dysfunction undergoing coronary angiography or intervention. Our hypothesis is that addition of sodium bicarbonate will be more efficacious than normal saline in preventing CIN at above situation.

### Conditions Module

**Conditions:**

- Contrast Induced Nephropathy

**Keywords:**

- sodium bicarbonate

- diabetes mellitus

- coronary angiography or intervention

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 368

**Type:** ESTIMATED

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** sodium bicarbonate

**Intervention Names:**

- Drug: Sodium bicarbonate

**Label:** Sodium bicarbonate

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** saline infusion

**Intervention Names:**

- Drug: saline

**Label:** Saline

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Sodium bicarbonate

**Description:** 3 mL/kg for 1 hour immediately before contrast injection , 1mg/kg/hr during procedure and 6 hours after procedure

**Name:** Sodium bicarbonate

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Saline

**Description:** 0.9% normal saline with 1 mL/kg/hr infusion 12 hours before procedure and 12 hours after procedure

**Name:** saline

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Incidence of contrast-induced nephropathy

**Time Frame:** 24 and 48 hours after angiography or intervention

#### Secondary Outcomes

**Measure:** all-cause mortality

**Time Frame:** 30 days after index angiography

**Measure:** stroke

**Time Frame:** 30 days after index angiography

**Measure:** Dialysis

**Time Frame:** 30 days after index angiography

**Measure:** Myocardial infarction

**Time Frame:** 30 days after index angiography

**Measure:** all-cause mortality

**Time Frame:** 30 days to 6 months after index angiography

**Measure:** stroke

**Time Frame:** 30 days to 6 months after index angiography

**Measure:** dialysis

**Time Frame:** 30 days to 6 months after index angiography

**Measure:** myocardial infarction

**Time Frame:** 30 days to 6 months after index angiography

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* age\>18 years, no upper limits
* diabetes treated with insulin or oral hypoglycemic agents
* serum creatinine \>=1.1 and
* resting estimated glomerular filtration rate \<60ml/min/1.73 square meter

Exclusion Criteria:

* serum creatinine \>=8mg/dL
* resting estimated GFR \<15ml/min/1.73 square meter
* end stage renal disease on hemodialysis
* multiple myeloma
* uncontrolled hypertension (systolic BP \>160mmHg or diastolic BP\>100mmHg)
* acute myocardial infarction
* emergent coronary angioplasty or angiography
* recent use of contrast within 2 days
* allergic reaction to contrast
* pregnancy
* allergic to following medication : theophylline, dopamine, mannitol, fenoldopam, N-acetylcysteine

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** swpark@amc.seoul.kr

**Name:** Seong-Wook Park, MD, PhD

**Phone:** 2-3010-3153

**Phone Ext:** 82

**Role:** CONTACT

**Contact 2:**

**Email:** seungwlee@amc.seoul.kr

**Name:** Seung-Whan Lee, MD, PhD

**Phone:** 2-3010-3170

**Phone Ext:** 82

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Bucheon

**Contacts:**

***Contact 1:***

- **Name:** Nae-Hee Lee, MD, PhD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Nae-Hee Lee, MD, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Korea, Republic of

**Facility:** Soonchunhyang University Bucheon Hospital

**Status:** RECRUITING

**Location 2:**

**City:** Busan

**Contacts:**

***Contact 1:***

- **Name:** Jae-Sik Jang, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Jae-Sik Jang, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Korea, Republic of

**Facility:** Busan Saint Mary Hospital

**Status:** RECRUITING

**Location 3:**

**City:** Cheonan

**Contacts:**

***Contact 1:***

- **Name:** Won-Yong Shin, MD, PhD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Dong-Gyu Jin, MD, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Korea, Republic of

**Facility:** Soonchunhyang University Hospital, Cheonan

**Status:** RECRUITING

**Location 4:**

**City:** Chuncheon

**Contacts:**

***Contact 1:***

- **Name:** Bong-Ki Lee, MD, PhD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Bong-Ki Lee

- **Role:** CONTACT

***Contact 3:***

- **Name:** Bong-Ki Lee, MD, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Korea, Republic of

**Facility:** Kangwon National University Hospital

**Status:** RECRUITING

**Location 5:**

**City:** Daejeon

**Contacts:**

***Contact 1:***

- **Name:** In-Whan Seong, MD, PhD

- **Role:** CONTACT

***Contact 2:***

- **Name:** In-Whan Seong, MD, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Korea, Republic of

**Facility:** Chungnam National University Hospital

**Status:** RECRUITING

**Location 6:**

**City:** Gangneung

**Contacts:**

***Contact 1:***

- **Name:** Sang-Sik Cheong

- **Role:** CONTACT

***Contact 2:***

- **Name:** Sang-Sik Cheong, MD, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Korea, Republic of

**Facility:** Gangneung Asan Hospital

**Status:** RECRUITING

**Location 7:**

**City:** Seoul

**Contacts:**

***Contact 1:***

- **Email:** swpark@amc.seoul.kr

- **Name:** Seong-Wook Park, MD, PhD

- **Phone:** 2-3010-3153

- **Phone Ext:** 82

- **Role:** CONTACT

***Contact 2:***

- **Email:** seungwlee@amc.seoul.kr

- **Name:** Seung-Whan Lee, MD, PhD

- **Phone:** 2-3010-3170

- **Phone Ext:** 82

- **Role:** CONTACT

***Contact 3:***

- **Name:** Seong-Wook Park, MD, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Korea, Republic of

**Facility:** Asan Medical Center

**Status:** RECRUITING

**Zip:** 138-736

**Location 8:**

**City:** Seoul

**Contacts:**

***Contact 1:***

- **Name:** Min-Su Hyun, MD, PhD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Min-Su Hyun, MD, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Korea, Republic of

**Facility:** Soonchunhyang University Seoul Hospital

**Status:** RECRUITING

**Location 9:**

**City:** Ulsan

**Contacts:**

***Contact 1:***

- **Name:** Sang-Gon Lee, MD, PhD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Sang-Gon Lee, MD, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Korea, Republic of

**Facility:** Ulsan University Hospital

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine

**Name:** Seong-Wook Park, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- 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: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

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

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: LOW

- As Found: Unknown

- ID: M10698

- Name: Kidney Diseases

- Relevance: HIGH

- As Found: Nephropathy

- ID: M26718

- Name: Renal Insufficiency

- 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

### Condition Browse Module - Meshes

- ID: D000007674

- Term: Kidney Diseases

### Misc Info Module

- Version Holder: 2024-05-24
