Prevention of Contrast Induced Nephropathy With Sodium Bicarbonate

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3

Details

• Lead Sponsor: Universidad de Antioquia

Criteria

Inclusion Criteria:

• 18+ years of age

• Inpatient at Hospital Universitario San Vicente de Paúl scheduled to undergo diagnostic CT scan using contrast or angiography and either

• Serum creatinine 1.2 mg/dl or more, or

• Type 2 Diabetes Mellitus

Exclusion Criteria:

• Current clinical diagnosis of exacerbated congestive heart failure

• Exposure to contrast 30 days prior to study

• Allergy to contrast dye

• Chronic renal disease with dialysis therapy

• Acute renal failure with dialytic urgency

• Urgency procedure needed

• Systolic blood pressure < 90 or vasopressor support

• No authorization by patient or physician in charge

• Serum potassium < 3 mEq/L

• Ejection fraction < 35% by previous echocardiography

• Acute pulmonary edema in previous 48 hours