Clinical Trial of Sodium Bicarbonate to Prevent Contrast-Induced Nephropathy
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|ClinicalTrials.gov Identifier: NCT00424320|
Recruitment Status : Unknown
Verified January 2007 by Instituto Nacional de Cardiologia Ignacio Chavez.
Recruitment status was: Recruiting
First Posted : January 19, 2007
Last Update Posted : January 19, 2007
|Condition or disease||Intervention/treatment||Phase|
|Acute Kidney Failure||Drug: Sodium bicarbonate||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||October 2006|
|Study Completion Date :||January 2007|
- Contrast-induced nephropathy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00424320
|Contact: Emma Miranda Malpica, PhD||52+55+55499120 ext email@example.com|
|ABC Medical Center||Recruiting|
|Mexico City, Mexico City (D.F.), Mexico, 01120|
|Contact: Jesús Simón Domínguez, PharmD 52+55+52308098|
|Principal Investigator: Jesús Simón Domínguez, PharmD|
|Ignacio Chávez National Institute of Cardiology||Recruiting|
|Mexico City, Mexico City (D.F:), Mexico, 14080|
|Contact: Emma M Miranda Malpica, MD, PhD 52+55+55732911 ext 1236 firstname.lastname@example.org|
|Principal Investigator: Emma M Miranda Malpica, MD, PhD|
|Sub-Investigator: Hilda E Delgadillo Rodríguez, MD|
|Principal Investigator: Juan P Herrera, MD|
|Sub-Investigator: Carlos J González-Quesada, MD|
|Principal Investigator: Marco A Peña Duque, MD|
|Sub-Investigator: Luís J Uribe González, MD, PhD|
|Sub-Investigator: Pedro A Reyes López, MD|
|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|