This trial is a randomized, controlled, open-label, parallel study. Patients at high risk for contrast induced acute kidney injury (CI AKI) and planned high-risk percutaneous coronary intervention (PCI) will be randomized to receive optimal medical care for the prevention of CI AKI with periprocedural hydration either in combination with or without use of an Impella device during PCI. Renal function will be assessed over 6 months, potential complications (in particular bleeding and access site complications) over one month. Effects of device-assisted PCI on pathways for salt and water handling, as well as on kidney oxygenation will be detected by sequential sampling of blood and urine as well as detection of magnetic resonance imaging indicative of blood kidney oxygenation (BOLD MRI).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
224
optimal medical care PCI
Impella-protected PCI
Heinrich-Heine-University, Div. of Cardiology, Pulmonary Disease and Vascular Medicine
Düsseldorf, North Rhine-Westphalia, Germany
RECRUITINGIncidence rate of Contrast-induced acute kidney injury (CI-AKI)
Incidence rate of AKI (Acute Kidney Injury Criteria 1-3) over 2 days after PCI
Time frame: 2 days after PCI
Change in eGFR
Time frame: at day 1 and day 3 from baseline (pre-PCI)
Incidence of acute kidney injury (AKIN Criteria 1-3)
Time frame: over 3 days after PCI
Incidence of dialysis
Incidence of dialysis during hospitalization and over 6 months after PCI
Time frame: up to 6 months after PCI
Incidence of re-hospitalization for renal dysfunction
Incidence of re-hospitalization for renal dysfunction over 30 days and 6 months after PCI
Time frame: 30 days and up to 6 months after PCI
Mortality
Mortality during hospital stay and over 6 months after PCI
Time frame: up to 6 months after PCI
Length of hospital stay
Time frame: up to 3 days after PCI
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