Fenoldopam for Prevention of Acute Kidney Injury

Phase 4

• Conditions: Coronary Artery Disease
• Interventions: Drug: standard saline infusion; Drug: fenoldopam infusion

• Registration Number: NCT01690832
• Lead Sponsor: University of Roma La Sapienza

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

Study Timeline

• Status Verified: 2012-09
• Study Start: 2012-09
• Study First Submitted: 2012-09-19
• Study First Submitted QC: 2012-09-19
• Last Update Submitted: 2012-09-19
• Study First Posted: 2012-09-24
• Last Update Posted: 2012-09-24
• Primary Completion: 2013-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Contrast induced acute kidney injury	48 hour	Incidence of contrast induced acute kidney injury at 48 hour post-procedural control

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sapienza University; 🇮🇹 Rome, Lazio, Italy