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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00950079

Enrollment

368

Registered

2009-07-31

Start date

2008-02-29

Completion date

2010-01-31

Last updated

2009-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contrast Induced Nephropathy

Keywords

sodium bicarbonate, diabetes mellitus, coronary angiography or intervention

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.

Interventions

DRUGSodium bicarbonate

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

DRUGsaline

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incidence of contrast-induced nephropathy	24 and 48 hours after angiography or intervention

Secondary

Measure	Time frame
stroke	30 days after index angiography
Dialysis	30 days after index angiography
all-cause mortality	30 days after index angiography
dialysis	30 days to 6 months after index angiography
myocardial infarction	30 days to 6 months after index angiography
Myocardial infarction	30 days after index angiography

Countries

South Korea

Contacts

Primary ContactSeong-Wook Park, MD, PhD

swpark@amc.seoul.kr2-3010-3153

Backup ContactSeung-Whan Lee, MD, PhD

seungwlee@amc.seoul.kr2-3010-3170

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026