Clinical Trial of Sodium Bicarbonate to Prevent Contrast-Induced Nephropathy
Recruitment status was: Recruiting
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||Clinical Controlled Trial to Determinate the Role of Sodium Bicarbonate in the Prevention of Contrast-Induced Nephropathy in High-Risk Patients Undergoing to Diagnostic Coronariography and/or Percutaneous Coronary Intervention|
- Contrast-induced nephropathy
|Study Start Date:||October 2006|
|Estimated Study Completion Date:||January 2007|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00424320
|ABC Medical Center|
|Mexico City, Mexico City (D.F.), Mexico, 01120|
|Ignacio Chávez National Institute of Cardiology|
|Mexico City, Mexico City (D.F:), Mexico, 14080|
|Principal Investigator:||Emma Miranda Malpica, PhD||Ignacio Chávez National Institute of Cardiology|
|Study Director:||Marco A Martínez Ríos, MD, FACC||Ignacio Chávez National Institute of Cardiology|
|Study Chair:||Jorge Gaspar Hernández, MD||Ignacio Chávez National Institute of Cardiology|