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Fenoldopam for Prevention of Acute Kidney Injury

Information source: University of Roma La Sapienza
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Coronary Artery Disease

Intervention: standard saline infusion (Drug); fenoldopam infusion (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: University of Roma La Sapienza

Official(s) and/or principal investigator(s):
Francesco Pelliccia, MD, Principal Investigator, Affiliation: Sapienza University

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: Contrast induced acute kidney injury

Secondary outcome: Markers of kidney injury

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Sapienza University, Rome, Lazio 00166, Italy
Additional Information

Starting date: September 2012
Last updated: September 19, 2012

Page last updated: August 23, 2015

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