MedDataX Logo

Prevention of Contrast-Induced Nephropathy in Diabetic Patients With Undergoing Coronary Angiography

NCT ID: NCT00950079

Last Updated: 2009-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

368 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2010-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Contrast Induced Nephropathy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

sodium bicarbonate diabetes mellitus coronary angiography or intervention

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sodium bicarbonate

sodium bicarbonate

Group Type EXPERIMENTAL

Sodium bicarbonate

Intervention Type DRUG

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

Saline

saline infusion

Group Type ACTIVE_COMPARATOR

saline

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sodium bicarbonate

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

Intervention Type DRUG

saline

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

CardioVascular Research Foundation, Korea

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Asan Medical Center

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Seong-Wook Park, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Soonchunhyang University Bucheon Hospital

Bucheon-si, , South Korea

Site Status RECRUITING

Busan Saint Mary Hospital

Busan, , South Korea

Site Status RECRUITING

Soonchunhyang University Hospital, Cheonan

Cheonan, , South Korea

Site Status RECRUITING

Kangwon National University Hospital

Chuncheon, , South Korea

Site Status RECRUITING

Chungnam National University Hospital

Daejeon, , South Korea

Site Status RECRUITING

Gangneung Asan Hospital

Gangneung, , South Korea

Site Status RECRUITING

Asan Medical Center

Seoul, , South Korea

Site Status RECRUITING

Soonchunhyang University Seoul Hospital

Seoul, , South Korea

Site Status RECRUITING

Ulsan University Hospital

Ulsan, , South Korea

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Seong-Wook Park, MD, PhD

Role: CONTACT

Phone: 2-3010-3153

Email: [email protected]

Seung-Whan Lee, MD, PhD

Role: CONTACT

Phone: 2-3010-3170

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Nae-Hee Lee, MD, PhD

Role: primary

Jae-Sik Jang, MD

Role: primary

Won-Yong Shin, MD, PhD

Role: primary

Bong-Ki Lee, MD, PhD

Role: primary

Bong-Ki Lee

Role: backup

In-Whan Seong, MD, PhD

Role: primary

Sang-Sik Cheong

Role: primary

Seong-Wook Park, MD, PhD

Role: primary

Seung-Whan Lee, MD, PhD

Role: backup

Min-Su Hyun, MD, PhD

Role: primary

Sang-Gon Lee, MD, PhD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2007-0180

Identifier Type: -

Identifier Source: org_study_id