Clinical Trial of Sodium Bicarbonate to Prevent Contrast-Induced Nephropathy

Acute Kidney Failure Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00424320
• Other study ID #: 06-001
• Status: Recruiting
• Phase: Phase 3
• First received: January 18, 2007
• Last updated: January 18, 2007
• Start date: October 2006
• Est. completion date: January 2007

Study information

• Verified date: January 2007
• Source: Instituto Nacional de Cardiologia Ignacio Chavez
• Contact: Emma Miranda Malpica, PhD
• Phone: 52+55+55499120
• Email: malpicae[@]yahoo.com.mx
• Is FDA regulated: No
• Health authority: Mexico: National Council of Science and Technology
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Kidney Failure
• Acute Kidney Injury
• Kidney Diseases
• Renal Insufficiency

Intervention

Drug:
• Sodium bicarbonate

Locations

Country	Name	City	State
Mexico	ABC Medical Center	Mexico City	Mexico City (D.F.)
Mexico	Ignacio Chávez National Institute of Cardiology	Mexico City	Mexico City (D.F:)

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Cardiologia Ignacio Chavez

Country where clinical trial is conducted

Mexico, 

References & Publications (9)

Aspelin P. Nephrotoxicity and the role of contrast media. Radiat Med. 2004 Nov-Dec;22(6):377-8. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Goldenberg I, Matetzky S. Nephropathy induced by contrast media: pathogenesis, risk factors and preventive strategies. CMAJ. 2005 May 24;172(11):1461-71. Review. Erratum in: CMAJ. 2005 Nov 8;173(10):1210. — View Citation

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. Epub 2005 Apr 9. Review. — View Citation

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. — View Citation

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. — View Citation

Rezkalla SH. Contrast nephropathy. Clin Med Res. 2003 Oct;1(4):301-4. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contrast-induced nephropathy
Secondary	Hemodialysis

External Links

•   National Institute of Cardiology