Fenoldopam for Prevention of Acute kidNey Injury in Patients With aCute coronarY Syndrome Undergoing Coronary Angiography and/or Percutaneous Coronary Intervention - The FANCY Trial
Overview
- Phase
- Phase 4
- Intervention
- standard saline infusion
- Conditions
- Coronary Artery Disease
- Sponsor
- University of Roma La Sapienza
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Contrast induced acute kidney injury
- Last Updated
- 13 years ago
Overview
Brief Summary
Patients with acute coronary syndromes (ACS) are at increased risk for acute kidney injury (AKI) when they undergo urgent/emergency 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 urgent/emergency coronary angiography and/or percutaneous coronary intervention.
Detailed Description
Patients with acute coronary syndromes (ACS) are at increased risk for acute kidney injury (AKI) when they undergo urgent/emergency 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 urgent/emergency coronary angiography and/or percutaneous coronary intervention. Patients will be randomized to standard i.v. 1 ml/kg/h saline infusion (Gr. A, N= 50) or to a combination of i.v. 1 ml/kg/h saline infusion and fenoldopam administration (0.08 mcg/Kg/min) 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
Investigators
Francesco Pelliccia
Assistant Professor
University of Roma La Sapienza
Eligibility Criteria
Inclusion Criteria
- •Indication to urgent/emergency coronary angiography
- •Normal renal function (eGFR\> 60 ml/min/1.73 m2)
- •Moderate or high Mehran's risk score for CIN (\>11).
- •Able to understand and willing to sign the informed CF
Exclusion Criteria
- •Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT
Arms & Interventions
standard saline infusion
standard i.v. 1 ml/kg/h saline infusion from 6 hours before the procedure to 12 hours after the procedure.
Intervention: standard saline infusion
fenoldopam infusion
combination of i.v. 1 ml/kg/h saline infusion and fenoldopam administration (0.08 mcg/Kg/min) from 6 hours before the procedure to 12 hours after the procedure.
Intervention: standard saline infusion
fenoldopam infusion
combination of i.v. 1 ml/kg/h saline infusion and fenoldopam administration (0.08 mcg/Kg/min) from 6 hours before the procedure to 12 hours after the procedure.
Intervention: fenoldopam infusion
Outcomes
Primary Outcomes
Contrast induced acute kidney injury
Time Frame: 48 hour
Incidence of contrast induced acute kidney injury at 48 hour post-procedural control
Secondary Outcomes
- Markers of kidney injury(48 hour)