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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 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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard saline infusion | Active Comparator | standard i.v. 1 ml/kg/h saline infusion from 6 hours before the procedure to 12 hours after the procedure. |
|
| fenoldopam infusion | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard saline infusion | Drug | i.v. 1 ml/kg/h saline infusion from 6 hours before the procedure to 12 hours after the procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Contrast induced acute kidney injury | Incidence of contrast induced acute kidney injury at 48 hour post-procedural control | 48 hour |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
• Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT
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| Name | Affiliation | Role |
|---|---|---|
| Francesco Pelliccia, MD | Sapienza University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sapienza University | Rome | Lazio | 00166 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39607014 | Derived | Esezobor CI, Bhatt GC, Effa EE, Hodson EM. Fenoldopam for preventing and treating acute kidney injury. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD012905. doi: 10.1002/14651858.CD012905.pub2. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| fenoldopam infusion | Drug | 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 |
|
|
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |