Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00424320
Status:
UNKNOWN
Last Update Posted:
2007-01-19
First Post:
2007-01-18
Brief Title:
Clinical Trial of Sodium Bicarbonate to Prevent Contrast-Induced Nephropathy
Sponsor:
Instituto Nacional de Cardiologia Ignacio Chavez
Organization:
Instituto Nacional de Cardiologia Ignacio Chavez
Study Overview
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 andor Percutaneous Coronary Intervention
Status:
UNKNOWN
Status Verified Date:
2007-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 136 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 todays most accepted prevention therapy is intravenous hydration with normal saline solution
Comparison Hydration previously during and afterwards contrast media administration with normal saline solution 09 compared to hydration previous during and afterwards contrast media administration with a solution made of normal saline and sodium bicarbonate
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 136 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 todays most accepted prevention therapy is intravenous hydration with normal saline solution
Comparison Hydration previously during and afterwards contrast media administration with normal saline solution 09 compared to hydration previous during and afterwards contrast media administration with a solution made of normal saline and sodium bicarbonate
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None