Fenoldopam for Prevention of Acute Kidney Injury (FANCY)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease |
Drug: standard saline infusion Drug: fenoldopam infusion |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| 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 |
- Contrast induced acute kidney injury [ Time Frame: 48 hour ] [ Designated as safety issue: No ]Incidence of contrast induced acute kidney injury at 48 hour post-procedural control
- Markers of kidney injury [ Time Frame: 48 hour ] [ Designated as safety issue: No ]Post-angiographic 48-h absolute increase in creatinine, absolute increase in estimated glomerular filtration rate, and Neutrophil gelatinase-associated lipocalin (NGAL) value
| Estimated Enrollment: | 100 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: standard saline infusion
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
i.v. 1 ml/kg/h saline infusion from 6 hours before the procedure to 12 hours after the procedure
Other Name: saline infusion
|
|
Active Comparator: 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.
|
Drug: standard saline infusion
i.v. 1 ml/kg/h saline infusion from 6 hours before the procedure to 12 hours after the procedure
Other Name: saline infusion
Drug: 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
Other Name: fenoldopam administration (0.08 mcg/Kg/min)
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Francesco Pelliccia, Assistant Professor, University of Roma La Sapienza |
| ClinicalTrials.gov Identifier: | NCT01690832 History of Changes |
| Other Study ID Numbers: | 595/2012/D |
| Study First Received: | September 19, 2012 |
| Last Updated: | September 19, 2012 |
| Health Authority: | Italy: Ministry of Health |
Keywords provided by University of Roma La Sapienza:
|
Contrast induced acute kidney injury |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Acute Kidney Injury Acute Coronary Syndrome Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Renal Insufficiency Kidney Diseases Urologic Diseases Angina Pectoris |
Chest Pain Pain Signs and Symptoms Fenoldopam Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Vasodilator Agents Dopamine Agonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013