NCT00531765

Sodium Bicarbonate in Preventing Contrast Induced Nephropathy

Sodium Bicarbonate in Preventing Contrast Induced Nephropathy (SIPCIN): A Randomized Controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: King Faisal Specialist Hospital & Research Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

We plan to conduct an open-label, randomized, stratified, parallel-group study to compare normal saline infusion to sodium bicarbonate infusion.

Detailed description

We plan to conduct an open-label, randomized, stratified, parallel-group study to compare normal saline infusion to sodium bicarbonate infusion. 220 adult patients scheduled for routine cardiac catheterization will be enrolled. They will stratified according to the presence or absence of DM, or an estimated GER of less than 60 ml/hr before being block-randomized to the two groups. The incidence of CIN will be determined based on the average of two measurements of creatinine level before and 48 hours after the procedure, and an increase of 25% or 0.5 mg/dL (44.2 umol/L) or more.

Conditions

• Contrast Induced Nephropathy

Interventions

Type	Name	Description
OTHER	sodium bicarbonate infusion	short infusion of sodium bicarbonate

Timeline

• Start date: 2007-06-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2007-09-19
• Last updated: 2010-07-27

Locations

1 site across 1 country: Saudi Arabia