Coronary Artery Disease
Conditions
Keywords
Contrast induced acute kidney injury
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
Interventions
DRUGstandard saline infusion
i.v. 1 ml/kg/h saline infusion from 6 hours before the procedure to 12 hours after the procedure
DRUGfenoldopam 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
Sponsors
University of Roma La Sapienza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Contrast induced acute kidney injury | 48 hour | Incidence of contrast induced acute kidney injury at 48 hour post-procedural control |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Outcome results
None listed