NCT00950079

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 368 (estimated)
• Sponsor: CardioVascular Research Foundation, Korea · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Contrast Induced Nephropathy

Interventions

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

Timeline

• Start date: 2008-02-01
• Primary completion: 2009-08-01
• Completion: 2010-01-01
• First posted: 2009-07-31
• Last updated: 2009-07-31

Locations

9 sites across 1 country: South Korea