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Clinical Trial of Sodium Bicarbonate to Prevent Contrast-Induced Nephropathy

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00424320
Enrollment
100
Registered
2007-01-19
Start date
2006-10-31
Completion date
2007-01-31
Last updated
2007-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Failure

Keywords

Acute kidney failure, Contrast-induced nephropathy, Non-ionic contrast media, Ionic contrast media, Iopamidol, Percutaneous coronary intervention, Coronariography

Brief summary

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

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.

Interventions

DRUGSodium bicarbonate

Sponsors

Instituto Nacional de Cardiologia Ignacio Chavez
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Contrast-induced nephropathy

Secondary

MeasureTime frame
Hemodialysis

Countries

Mexico

Contacts

Primary ContactEmma Miranda Malpica, PhD
malpicae@yahoo.com.mx52+55+55499120

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026