Fenoldopam for Prevention of Acute Kidney Injury (FANCY)

University of Roma La Sapienza

Status and phase: Unknown; Phase 4

Conditions: Coronary Artery Disease

Treatments: Drug: fenoldopam infusion; Drug: standard saline infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT01690832

595/2012/D

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

standard saline infusion

Active Comparator group

Description:

standard i.v. 1 ml/kg/h saline infusion from 6 hours before the procedure to 12 hours after the procedure.

Treatment:

Drug: standard saline infusion

fenoldopam infusion

Active Comparator group

Description:

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.

Treatment:

Drug: standard saline infusion

Drug: fenoldopam infusion