Clinical Trial of Sodium Bicarbonate to Prevent Contrast-Induced Nephropathy
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Purpose
The purpose of this study is to determine whether sodium bicarbonate is effective in the prevention of sodium-induced nephropathy
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Kidney Failure |
Drug: Sodium bicarbonate |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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
- Hemodialysis
| Estimated Enrollment: | 100 |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Emma Miranda Malpica, PhD | 52+55+55499120 ext 1232 | malpicae@yahoo.com.mx |
| Mexico | |
| 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 malpicae@yahoo.com.mx | |
| 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 |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00424320 History of Changes |
| Other Study ID Numbers: | 06-001 |
| Study First Received: | January 18, 2007 |
| Last Updated: | January 18, 2007 |
| Health Authority: | Mexico: National Council of Science and Technology |
Keywords provided by Instituto Nacional de Cardiologia Ignacio Chavez:
|
Acute kidney failure Contrast-induced nephropathy Non-ionic contrast media Ionic contrast media |
Iopamidol Percutaneous coronary intervention Coronariography |
Additional relevant MeSH terms:
|
Kidney Diseases Acute Kidney Injury Renal Insufficiency Urologic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013