Oral Versus Intravenous Hydration to Prevent Contrast Induced Nephropathy — HYDRATE  

Contrast Induced Nephropathy Clinical Trial

Official title: Oral Hydration and Alkalinization is Non-Inferior to Intravenous Therapy for Prevention of Contrast Induced Nephropathy in Patients With Chronic Kidney Disease.

Status Withdrawn

Clinical Trial Summary

The increased risk for contrast-induced nephropathy (CIN) in patients with chronic kidney disease (CKD) undergoing coronary angiography (CAG) has been established. Current and historical data on CIN prevention strategies have shown wide variation with respect to the optimal type, route and timing of these therapies. We investigate the role for oral hydration and/or oral sodium bicarbonate administration compared to intravenous hydration and/or sodium bicarbonate in patients with CKD undergoing CAG.

Clinical Trial Description

This is a single center study randomizing patients with CKD undergoing CAG into 4 groups: 1) Intravenous normal saline, 2) Intravenous normal saline and intravenous bicarbonate, 3) oral hydration, and 4) oral hydration and oral bicarbonate. The primary endpoint was the occurrence of contrast-medium-induced nephropathy defined as greater than 25% increase in serum creatinine from baseline or an absolute increase of 0.5 mg/dL from baseline at 72 hours following exposure to radiocontrast. Secondary endpoints include the length of hospitalization and in-house mortality. ;

Related Conditions & MeSH terms

• Contrast Induced Nephropathy
• Kidney Diseases

• NCT number: NCT01093131
• Study type: Interventional
• Source: The Western Pennsylvania Hospital
• Status: Withdrawn
• Phase: Phase 4
• Start date: February 2005
• Completion date: February 2010