NCT00472563

Prevention of Contrast Induced Nephropathy With Sodium Bicarbonate

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 212 (actual)
• Sponsor: Universidad de Antioquia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

Deterioration of kidney renal function occurs in a minority of people due to contrast-required procedures. The purpose of this study is to compare two different interventions to reduce the risk of kidney injury after contrast medium exposition. We will perform a randomized clinical trial following a modification of a previously published protocol (Merten et al.JAMA 2004;291(19):2328-34). Patients will be randomly assigned to one of two groups of treatment. Group A will receive 1 cc/kg/hour of 0.9% saline infusion starting 12 hours before and continuing 12 hours after the procedure. Group B will receive 3 cc/kg of sodium bicarbonate solution for one hour prior to procedure, then drip rate will be decreased to 1 cc/kg/hour until 6 hours post procedure.

Detailed description

We will perform a randomized clinical trial following a modification of a previously published protocol (Merten et al.JAMA 2004;291(19):2328-34). Patients will be randomly assigned to one of two groups of treatment. Group A will receive 1 cc/kg/hour of 0.9% saline infusion starting 12 hours before and continuing 12 hours after the procedure. Group B will receive 3 cc/kg of sodium bicarbonate solution for one hour prior to procedure, then drip rate will be decreased to 1 cc/kg/hour until 6 hours post procedure. Phase 2/3 study Study Type: Interventional Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study. Subjects: Consecutive samples of all inpatients who meet the inclusion criteria Primary outcomes: Development of contrast induced nephropathy, defined as an increase in serum creatinine of 25% or more within 48 h after administration of contrast. Secondary outcomes: change in serum bicarbonate; change in serum potassium; change in serum creatinine. Expected total enrollment: 212 Allocation Assignment: Patients who meet inclusion criteria and agree to participate in the study will be assigned by a random number table to saline or bicarbonate, using closed envelopes and stratifying according to history of diabetes and type of procedure (cardiac catheterism or others). Condition: Contrast Induced Nephropathy Intervention: 75 cc of sodium bicarbonate (8.4%) mixed in 425 cc of D5W Gender: both Age: 18+ years of age Recruitment Status: participants are currently being recruited Facility location: Universidad de Antioquia, Internal Medicine Department; Hospital Universitario San Vicente de Paul. Medellin, Colombia.

Conditions

• Acute Kidney Failure

Interventions

Type	Name	Description
DRUG	Bicarbinate 150 mEq/L	75 cc of sodium bicarbonate (8.4%) mixed in 425 cc of D5W

Timeline

• Start date: 2007-05-01
• Primary completion: 2008-02-01
• Completion: 2008-02-01
• First posted: 2007-05-11
• Last updated: 2008-05-06

Locations

1 site across 1 country: Colombia