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

Contrast Induced Nephropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00950079
• Other study ID #: 2007-0180
• Status: Recruiting
• Phase: Phase 4
• First received: July 6, 2009
• Last updated: July 30, 2009
• Start date: February 2008
• Est. completion date: January 2010

Study information

• Verified date: July 2009
• Source: CardioVascular Research Foundation, Korea
• Contact: Seong-Wook Park, MD, PhD
• Phone: 2-3010-3153
• Email: swpark[@]amc.seoul.kr
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 368
• Est. completion date: January 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Contrast Induced Nephropathy
• Kidney Diseases

Intervention

Drug:
• Sodium bicarbonate
3 mL/kg for 1 hour immediately before contrast injection , 1mg/kg/hr during procedure and 6 hours after procedure
• saline
0.9% normal saline with 1 mL/kg/hr infusion 12 hours before procedure and 12 hours after procedure

Locations

Country	Name	City	State
Korea, Republic of	Soonchunhyang University Bucheon Hospital	Bucheon
Korea, Republic of	Busan Saint Mary Hospital	Busan
Korea, Republic of	Soonchunhyang University Hospital, Cheonan	Cheonan
Korea, Republic of	Kangwon National University Hospital	Chuncheon
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Gangneung Asan Hospital	Gangneung
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Soonchunhyang University Seoul Hospital	Seoul
Korea, Republic of	Ulsan University Hospital	Ulsan

Sponsors (1)

Lead Sponsor	Collaborator
CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of contrast-induced nephropathy		24 and 48 hours after angiography or intervention	No
Secondary	all-cause mortality		30 days after index angiography	Yes
Secondary	stroke		30 days after index angiography	Yes
Secondary	Dialysis		30 days after index angiography	Yes
Secondary	Myocardial infarction		30 days after index angiography	Yes
Secondary	all-cause mortality		30 days to 6 months after index angiography	Yes
Secondary	stroke		30 days to 6 months after index angiography	Yes
Secondary	dialysis		30 days to 6 months after index angiography	Yes
Secondary	myocardial infarction		30 days to 6 months after index angiography	Yes