Clinical Trial of Sodium Bicarbonate to Prevent Contrast-Induced Nephropathy

January 18, 2007 updated by: Instituto Nacional de Cardiologia Ignacio Chavez

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Mexico City (D.F.)
      • Mexico City, Mexico City (D.F.), Mexico, 01120
        • Recruiting
        • ABC Medical Center
        • Contact:
          • Jesús Simón Domínguez, PharmD
          • Phone Number: 52+55+52308098
        • Principal Investigator:
          • Jesús Simón Domínguez, PharmD
    • Mexico City (D.F:)
      • Mexico City, Mexico City (D.F:), Mexico, 14080
        • Recruiting
        • Ignacio Chávez National Institute of Cardiology
        • Contact:
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Contrast-induced nephropathy

Secondary Outcome Measures

Outcome Measure
Hemodialysis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Study Completion

January 1, 2007

Study Registration Dates

First Submitted

January 18, 2007

First Submitted That Met QC Criteria

January 18, 2007

First Posted (Estimate)

January 19, 2007

Study Record Updates

Last Update Posted (Estimate)

January 19, 2007

Last Update Submitted That Met QC Criteria

January 18, 2007

Last Verified

January 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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