Ignite Creation Date:
2024-05-06 @ 12:58 AM
Last Modification Date:
2024-10-26 @ 10:56 AM
Study NCT ID:
NCT01690832
Status:
UNKNOWN
Last Update Posted:
2012-09-24
First Post:
2012-09-19
Brief Title:
Fenoldopam for Prevention of Acute Kidney Injury
Sponsor:
University of Roma La Sapienza
Organization:
University of Roma La Sapienza
Study Overview
Official Title:
Fenoldopam for Prevention of Acute kidNey Injury in Patients With aCute coronarY Syndrome Undergoing Coronary Angiography andor Percutaneous Coronary Intervention - The FANCY Trial
Status:
UNKNOWN
Status Verified Date:
2012-09
Last Known Status:
ACTIVE_NOT_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:
FANCY
Brief Summary:
Patients with acute coronary syndromes ACS are at increased risk for acute kidney injury AKI when they undergo urgentemergency coronary angiography
The optimal medical treatment for preventing the occurrence of contrast induced - acute kidney injury is still controversial
Fenoldopam mesylate is a dopamine A1 receptor agonist that augments renal plasma flow that has reduced the risk of radiocontrast dye nephropathy in some but not all preliminary studies
Neutrophil gelatinase-associated lipocalin NGAL is a new biomarker predictive for AKI already shown to be useful for earlier diagnosis of contrast induced nephropathy
The primary objective of this study is to to test the hypothesis that fenoldopam in addition to standard treatment reduce the occurrence of contrast induced - acute kidney injury in patients with acute coronary syndrome ACS undergoing urgentemergency coronary angiography andor percutaneous coronary intervention
The optimal medical treatment for preventing the occurrence of contrast induced - acute kidney injury is still controversial
Fenoldopam mesylate is a dopamine A1 receptor agonist that augments renal plasma flow that has reduced the risk of radiocontrast dye nephropathy in some but not all preliminary studies
Neutrophil gelatinase-associated lipocalin NGAL is a new biomarker predictive for AKI already shown to be useful for earlier diagnosis of contrast induced nephropathy
The primary objective of this study is to to test the hypothesis that fenoldopam in addition to standard treatment reduce the occurrence of contrast induced - acute kidney injury in patients with acute coronary syndrome ACS undergoing urgentemergency coronary angiography andor percutaneous coronary intervention
Detailed Description:
Patients with acute coronary syndromes ACS are at increased risk for acute kidney injury AKI when they undergo urgentemergency coronary angiography
The optimal medical treatment for preventing the occurrence of contrast induced - acute kidney injury is still controversial
Fenoldopam mesylate is a dopamine A1 receptor agonist that augments renal plasma flow that has reduced the risk of radiocontrast dye nephropathy in some but not all preliminary studies
Neutrophil gelatinase-associated lipocalin NGAL is a new biomarker predictive for AKI already shown to be useful for earlier diagnosis of contrast induced nephropathy
The primary objective of this study is to to test the hypothesis that fenoldopam in addition to standard treatment reduce the occurrence of contrast induced - acute kidney injury in patients with acute coronary syndrome ACS undergoing urgentemergency coronary angiography andor percutaneous coronary intervention
Patients will be randomized to standard iv 1 mlkgh saline infusion Gr A N 50 or to a combination of iv 1 mlkgh saline infusion and fenoldopam administration 008 mcgKgmin from 6 hours before the procedure to 12 hours after the procedure
Primary End-points
Incidence of contrast induced acute kidney injury
Secondary End-points
Post-angiographic 48-h absolute increase in creatinine absolute increase in estimated glomerular filtration rate and Neutrophil gelatinase-associated lipocalin NGAL value
The optimal medical treatment for preventing the occurrence of contrast induced - acute kidney injury is still controversial
Fenoldopam mesylate is a dopamine A1 receptor agonist that augments renal plasma flow that has reduced the risk of radiocontrast dye nephropathy in some but not all preliminary studies
Neutrophil gelatinase-associated lipocalin NGAL is a new biomarker predictive for AKI already shown to be useful for earlier diagnosis of contrast induced nephropathy
The primary objective of this study is to to test the hypothesis that fenoldopam in addition to standard treatment reduce the occurrence of contrast induced - acute kidney injury in patients with acute coronary syndrome ACS undergoing urgentemergency coronary angiography andor percutaneous coronary intervention
Patients will be randomized to standard iv 1 mlkgh saline infusion Gr A N 50 or to a combination of iv 1 mlkgh saline infusion and fenoldopam administration 008 mcgKgmin from 6 hours before the procedure to 12 hours after the procedure
Primary End-points
Incidence of contrast induced acute kidney injury
Secondary End-points
Post-angiographic 48-h absolute increase in creatinine absolute increase in estimated glomerular filtration rate and Neutrophil gelatinase-associated lipocalin NGAL value
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