Clinical Trial of Sodium Bicarbonate to Prevent Contrast-Induced Nephropathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by Instituto Nacional de Cardiologia Ignacio Chavez.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Instituto Nacional de Cardiologia Ignacio Chavez
ClinicalTrials.gov Identifier:
NCT00424320
First received: January 18, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Instituto Nacional de Cardiologia Ignacio Chavez:

Primary Outcome Measures:
  • Contrast-induced nephropathy

Secondary Outcome Measures:
  • Hemodialysis

Estimated Enrollment: 100
Study Start Date: October 2006
Estimated Study Completion Date: January 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00424320

Contacts
Contact: Emma Miranda Malpica, PhD 52+55+55499120 ext 1232 malpicae@yahoo.com.mx

Locations
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         
Sponsors and Collaborators
Instituto Nacional de Cardiologia Ignacio Chavez
Investigators
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
Renal Insufficiency
Acute Kidney Injury
Urologic Diseases
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014