the hypothesis is that elevation of the intrarenal resistive index (RI) characterizes patients at elevated risk for subsequent CA-AKI and integrates items of the Mehran AKI risk score into a single, readily obtainable parameter. Impella-mediated nephroprotection confers to reduction of elevated RI by restoration of intrarenal venous flow profile.
Contrast-associated acute kidney injury (CA-AKI) occurs in up to 10% of patients undergoing percutaneous coronary intervention (PCI) for coronary revascularization. CA-AKI is associated with impaired long-term outcome. This causes so-called "Renalism", describing the fact that patients with chronic kidney disease (CKD) in need of live-saving revascularizations are not offered PCI procedures in the risk of imminent CA-AKI. Retrospective studies and one-single-center pilot study described protective effects of Impella-protected PCI to reduce the incidence of CA-AKI. However, mechanisms involved of nephroprotection by Impella remain obscure. Deciphering these, is a prerequisite to tailor nephroprotection to the patients in need and to gain a label for nephroprotection by Impella.
Study Type
OBSERVATIONAL
Enrollment
550
Observational
Department of Cardiology, Angiology and Intensive Care Medicine Campus at German Heart Center Charite
Berlin, Germany
RECRUITINGDivision of Cardiology, Pulmonary Disease and Vascular Medicine at University Hospital Duesseldorf
Düsseldorf, Germany
RECRUITINGIntrarenal Resistive Index (RI)
unitless, sonographic index measured in intrarenal arteries defined as (peak systolic velocity - end-diastolic velocity ) / peak systolic velocity.
Time frame: immediately and 24 hours after PCI
Acute Kidney Injury
Increase in serum creatinine by at least 0.3 mg/dl within 48 hours, or increase in serum creatinine at least 1.5 times the known or assumed baseline value within seven days
Time frame: 48 hours respectively within 7 days
Serum creatinine (mg/dl) and calculated creatinine clearance (ml/min) in relation to RI (Intrarenal Resistive Index) an Mehran score (unitiles)
Relation calculated by Pearson correlation
Time frame: maximum change 24 hours post intervention compared to baseline
α2macroglobulin urine concentration in relation to RI and Mehran score (unitiless).
Relation calculated by Pearson correlation
Time frame: maximum change 24 hours post intervention compared to baseline
NGAL urine concentration (ng/ml) in subgroup analysis in relation to RI and mehran score (unitless);
Relation calculated by Pearson correlation
Time frame: maximum change 24 hours post intervention compared to baseline
Reclassification of AKI Risk by determined cutoff value for RI compared to classic Mehran score
Time frame: maximum change day 1 or day 2 post intervention compared to baseline
Length of stay in relation to RI and classic Mehran score.
Time frame: Hospital admission until discharge (assessed up to maximum of 10 days)
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Hierarchical clinical endpoint of AKI > rise of urinary α2macroglobulin concentration post PCI > increase of RI post PCI in Impella-protected patients versus non-Impella-protected patients matched by Mehran score
Time frame: maximum change day 1 or day 2 post intervention compared to baseline
Change of RI (Intrarenal Resistive Index) by Impella comparing RI at performance levels P0 and P9 at the begin of the intervention in every Impella-protected patient.
Time frame: during Impella treatment (up to 14 days)