Fenoldopam for Prevention of Acute Kidney Injury

Study Overview
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Brief Summary
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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
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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

Official Title
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Fenoldopam for Prevention of Acute kidNey Injury in Patients With aCute coronarY Syndrome Undergoing Coronary Angiography and/or Percutaneous Coronary Intervention - The FANCY Trial

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: standard saline infusion
* Drug: fenoldopam infusion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard saline infusion<br>standard i.v. 1 ml/kg/h saline infusion from 6 hours before the procedure to 12 hours after the procedure. | Drug: standard saline infusion<br>* i.v. 1 ml/kg/h saline infusion from 6 hours before the procedure to 12 hours after the procedure<br>* Other names: saline infusion;|
| Active Comparator: fenoldopam infusion<br>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. | Drug: standard saline infusion<br>* i.v. 1 ml/kg/h saline infusion from 6 hours before the procedure to 12 hours after the procedure<br>* Other names: saline infusion;Drug: fenoldopam infusion<br>* 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<br>* Other names: fenoldopam administration (0.08 mcg/Kg/min);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contrast induced acute kidney injury | Incidence of contrast induced acute kidney injury at 48 hour post-procedural control | 48 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Markers of kidney injury | Post-angiographic 48-h absolute increase in creatinine, absolute increase in estimated glomerular filtration rate, and Neutrophil gelatinase-associated lipocalin (NGAL) value | 48 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contrast induced acute kidney injury