Clinical Trial of Sodium Bicarbonate to Prevent Contrast-Induced Nephropathy
NCT ID: NCT00424320
Last Updated: 2007-01-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE3
100 participants
INTERVENTIONAL
2006-10-31
2007-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of Sodium Bicarbonate to Reduce the Incidence of Contrast Induced Chronic Kidney Injury in Patients With Kidney Disease
NCT00930436
The Use of Sodium Bicarbonate in the Prevention of Contrast Induced Nephropathy
NCT00494637
COmbined N-acetylcysteine and Bicarbonate in PCI To Reduce Adverse Side Effect of contrasT
NCT00497328
Sodium Bicarbonate for Prevention of Contrast-Induced Nephropathy
NCT01172353
Prevention of Contrast Induced Nephropathy With Sodium Bicarbonate
NCT00472563
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sodium bicarbonate
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Instituto Nacional de Cardiologia Ignacio Chavez
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Emma Miranda Malpica, PhD
Role: PRINCIPAL_INVESTIGATOR
Ignacio Chávez National Institute of Cardiology
Marco A Martínez Ríos, MD, FACC
Role: STUDY_DIRECTOR
Ignacio Chávez National Institute of Cardiology
Jorge Gaspar Hernández, MD
Role: STUDY_CHAIR
Ignacio Chávez National Institute of Cardiology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
ABC Medical Center
Mexico City, Mexico City (d.f.), Mexico
Ignacio Chávez National Institute of Cardiology
Mexico City, Mexico City (d.f:), Mexico
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Jesús Simón Domínguez, PharmD
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Bagshaw SM, Ghali WA. Acetylcysteine for prevention of contrast-induced nephropathy after intravascular angiography: a systematic review and meta-analysis. BMC Med. 2004 Oct 22;2:38. doi: 10.1186/1741-7015-2-38.
Itoh Y, Yano T, Sendo T, Oishi R. Clinical and experimental evidence for prevention of acute renal failure induced by radiographic contrast media. J Pharmacol Sci. 2005 Apr;97(4):473-88. doi: 10.1254/jphs.crj05002x. Epub 2005 Apr 9.
Aspelin P. Nephrotoxicity and the role of contrast media. Radiat Med. 2004 Nov-Dec;22(6):377-8. No abstract available.
Mueller C, Seidensticker P, Buettner HJ, Perruchoud AP, Staub D, Christ A, Buerkle G. Incidence of contrast nephropathy in patients receiving comprehensive intravenous and oral hydration. Swiss Med Wkly. 2005 May 14;135(19-20):286-90. doi: 10.4414/smw.2005.10938.
Goldenberg I, Matetzky S. Nephropathy induced by contrast media: pathogenesis, risk factors and preventive strategies. CMAJ. 2005 May 24;172(11):1461-71. doi: 10.1503/cmaj.1040847.
Cavusoglu E, Chhabra S, Marmur JD, Kini A, Sharma SK. The prevention of contrast-induced nephropathy in patients undergoing percutaneous coronary intervention. Minerva Cardioangiol. 2004 Oct;52(5):419-32.
Rezkalla SH. Contrast nephropathy. Clin Med Res. 2003 Oct;1(4):301-4. doi: 10.3121/cmr.1.4.301.
Merten GJ, Burgess WP, Gray LV, Holleman JH, Roush TS, Kowalchuk GJ, Bersin RM, Van Moore A, Simonton CA 3rd, Rittase RA, Norton HJ, Kennedy TP. Prevention of contrast-induced nephropathy with sodium bicarbonate: a randomized controlled trial. JAMA. 2004 May 19;291(19):2328-34. doi: 10.1001/jama.291.19.2328.
Briguori C, Airoldi F, Morici N, Colombo A. New pharmacological protocols to prevent or reduce contrast media nephropathy. Minerva Cardioangiol. 2005 Feb;53(1):49-58.
Related Links
Access external resources that provide additional context or updates about the study.
National Institute of Cardiology
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
06-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.