Ignite Creation Date:
2024-05-05 @ 9:39 PM
Last Modification Date:
2024-10-26 @ 10:08 AM
Study NCT ID:
NCT00939913
Status:
UNKNOWN
Last Update Posted:
2009-09-18
First Post:
2009-07-14
Brief Title:
Effect of Intravenous Acetadote on Incidence of Contrast Induced Nephropathy
Sponsor:
Ochsner Health System
Organization:
Ochsner Health System
Study Overview
Official Title:
N-Acetylcysteine to Prevent Contrast-Induced Nephropathy in Acute Coronary Syndromes
Status:
UNKNOWN
Status Verified Date:
2009-09
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:
NAC
Brief Summary:
In patients undergoing coronary angiography the incidence of contrast induced nephropathyCINvaries widely and ranges from 5 in the lowest risk patients to nearly 50 in the highest risk patients Prior data has shown oral n-acetyl cysteine NAC to be effective in reducing the incidence of CINDue to extensive first pass metabolism the bioavailability of oral NAC is poor and ranges from 4-10 We hypothesize that the incidence of CIN will be reduced in patients with ACS who undergo PCI by the prophylactic administration of intravenous NAC
This is a prospective randomized double-blind placebo-controlled single center clinical trial designed to evaluate the effects of intravenous NAC on patients with acute coronary syndromes ACSundergoing coronary angiography andor percutaneous coronary intervention PCI The medication Acetadote is provided by Cumberland Pharmaceuticals Inc wwwcumberlandpharmacom
Patients will be excluded if they have end-stage renal disease requiring dialysisknown hypersensitivity to NAC or a history of life-threatening contrast reaction Primary end-point is incidence of CIN Secondary end-points are in-hospital mortality30-day mortalityduration of hospitalization and change in serum cystatin C level
This is a prospective randomized double-blind placebo-controlled single center clinical trial designed to evaluate the effects of intravenous NAC on patients with acute coronary syndromes ACSundergoing coronary angiography andor percutaneous coronary intervention PCI The medication Acetadote is provided by Cumberland Pharmaceuticals Inc wwwcumberlandpharmacom
Patients will be excluded if they have end-stage renal disease requiring dialysisknown hypersensitivity to NAC or a history of life-threatening contrast reaction Primary end-point is incidence of CIN Secondary end-points are in-hospital mortality30-day mortalityduration of hospitalization and change in serum cystatin C level
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