Clinical trial NCT00950079: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Contrast Induced Nephropathy
Keywords: sodium bicarbonate
diabetes mellitus
coronary angiography or intervention
Lead sponsor: CardioVascular Research Foundation, Korea
Sponsor class: OTHER
First posted: 2009-07-31
Enrollment: 368
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Incidence of contrast-induced nephropathy
timeFrame: 24 and 48 hours after angiography or intervention
Secondary outcomes:
measure: all-cause mortality
timeFrame: 30 days after index angiography
measure: stroke
timeFrame: 30 days after index angiography
measure: Dialysis
timeFrame: 30 days after index angiography
measure: Myocardial infarction
timeFrame: 30 days after index angiography
measure: all-cause mortality
timeFrame: 30 days to 6 months after index angiography
measure: stroke
timeFrame: 30 days to 6 months after index angiography
measure: dialysis
timeFrame: 30 days to 6 months after index angiography
measure: myocardial infarction
timeFrame: 30 days to 6 months after index angiography
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Soonchunhyang University Bucheon Hospital
city: Busan
country: Korea, Republic of
facility: Busan Saint Mary Hospital
city: Cheonan
country: Korea, Republic of
facility: Soonchunhyang University Hospital, Cheonan
city: Chuncheon
country: Korea, Republic of
facility: Kangwon National University Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Gangneung
country: Korea, Republic of
facility: Gangneung Asan Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Soonchunhyang University Seoul Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
affiliation: Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
name: Seong-Wook Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: