Clinical Trial of Sodium Bicarbonate to Prevent Contrast-Induced Nephropathy

Phase 3

• Conditions: Acute Kidney Failure

• Registration Number: NCT00424320
• Lead Sponsor: Instituto Nacional de Cardiologia Ignacio Chavez

Brief Summary

The purpose of this study is to determine whether sodium bicarbonate is effective in the prevention of sodium-induced nephropathy

Detailed Description

The use of contrast media is more frequent as new diagnostic and therapeutic procedures are developed. As a consequence, the occurrence of acute renal failure (ARF), also known as contrast-induced nephropathy, is more frequently seen after the realization of these procedures, representing about 10% of all in-hospital ARF. The importance of preventing this complication is related with its strong association with higher morbidity and mortality rates in patients who present it. A number of drugs and interventions have been studied for preventing contrast-induced nephropathy, including intravenous hydration with normal and hypotonic saline solutions, oral hydration, mannitol, diuretics, dopamine and its antagonists (fenoldopam), calcium antagonists, theophylline, N-acetylcysteine, natriuretic atrial peptide and hemodialysis after or during contrast media administration.

There is only one study in humans that demonstrates the utility of the sodium bicarbonate to prevent the contrast-induced nephropathy, showing a reduction in the incidence of this complication of about 13.6%. Although this result could seem convincing, its relevance has been questioned because the definition used by the authors as contrast-induced nephropathy was an increase of 25% from basal creatinine. Although when compared, the absolute differences between basal and after-procedure creatinines were not statistically significative, the sample size was small and the participants were low-risk patients to develop contrast-induced nephropathy. It is also important to note that the control group was hydrated with a dextrose 5% solution with 154 mEq of NaCl, although today's most accepted prevention therapy is intravenous hydration with normal saline solution.

Comparison: Hydration previously, during and afterwards contrast media administration with normal saline solution (0.9%), compared to hydration previous, during and afterwards contrast media administration with a solution made of normal saline and sodium bicarbonate.

Study Timeline

• Study Start: 2006-10
• Status Verified: 2007-01
• Study Completion: 2007-01
• Study First Submitted: 2007-01-18
• Study First Submitted QC: 2007-01-18
• Last Update Submitted: 2007-01-18
• Study First Posted: 2007-01-19
• Last Update Posted: 2007-01-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Age over 18 years old
• Indication for coronariography and/or percutaneous coronary intervention
• Voluntary written consent for the realization of coronariography and/or percutaneous intervention and for the participation in this clinical trial
• A MEHRAN contrast-induced nephropathy score of six or more

Exclusion Criteria

• Patients with chronic kidney failure requiring any kind of dialysis
• Patients unable to complete follow-up
• Multiple myeloma
• Exposure to contrast 48 hours prior to study
• Pregnancy
• Patients unable to give consent
• Already receiving sodium bicarbonate solutions
• Receiving contrast media other than non-ionic

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Contrast-induced nephropathy

Secondary Outcome Measures

Name	Time	Method
Hemodialysis

Trial Locations

Locations (2)

ABC Medical Center; 🇲🇽 Mexico City, Mexico City (D.F.), Mexico

Ignacio Chávez National Institute of Cardiology; 🇲🇽 Mexico City, Mexico City (D.F:), Mexico