Viewing Study NCT00312117



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Last Modification Date: 2024-10-26 @ 9:24 AM
Study NCT ID: NCT00312117
Status: COMPLETED
Last Update Posted: 2015-03-11
First Post: 2006-04-05

Brief Title: Trial for Prevention of Contrast Nephropathy With Sodium Bicarbonate
Sponsor: Kaiser Permanente
Organization: Kaiser Permanente

Study Overview

Official Title: A Randomized Trial for Prevention of Contrast Nephropathy With Sodium Bicarbonate
Status: COMPLETED
Status Verified Date: 2015-03
Last Known Status: None
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: Contrast nephropathy CN is a common cause of renal failure associated with prolonged hospitalization significant morbiditymortality and cost In addition these patients may require temporary or permanent hemodialysis which in turn is associated with further morbidity mortality and cost CN has been reported to account for 10 of hospital acquired renal failure In recent years studies have investigated preventive therapies with mixed results Fenoldopam was found to be ineffective in a large randomized trial Dopamine has been shown to be ineffective as a preventive strategy Hemofiltration has been shown to be beneficial New England Journal of Medicine NEJM 2003 but is costly and not practical Mucomyst has shown mixed results The single strategy which most would agree as being beneficial remains hydration most commonly with intravenous 09 normal saline Most recently sodium bicarbonate has been shown to be beneficial in a small randomized trial n119 It is clear that the most cost effective strategies for treatment of CN should be aimed at prevention

The general question is Is a sodium bicarbonate solution more efficacious in preventing contrast nephropathy compared to normal saline The general hypothesis is that sodium bicarbonate will be more efficacious
Detailed Description: None

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