IntraRenal HEmoDynamics to IntegraTE CA-AKI Risk and Monitor NephroprotectiIoN by ImpElla Support.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Kidney Diseases
- Sponsor
- Heinrich-Heine University, Duesseldorf
- Enrollment
- 550
- Locations
- 2
- Primary Endpoint
- Intrarenal Resistive Index (RI)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects must meet all of the Inclusion Criteria to participate in the trial.
- •Age ≥18 years and \<90 years
- •Scheduled for PCI or PROTECTED PCI in near future (1 week) or PCI same day.
Exclusion Criteria
- •Subjects must NOT meet any of the following Exclusion Criteria to participate in the trial.
- •Severe chronic kidney disease with eGFR ≤ 20 ml/min or on dialysis
- •Patients with AKI within the last seven days prior screening or incipient AKI (in cases, where AKI cannot be ruled out as a cause for elevated serum creatinine, a rise or fall above 30% of a second serum creatinine measurement obtained within 12 to 24 hours is regarded indicative of AKI).
- •STEMI ≤24 hours from the onset of ischemic symptoms or at any time if mechanical complications of transmural infarction are present (e.g., VSD, papillary muscle rupture, etc.)
- •Cardiogenic shock (SBP \<80 mmHg for ≥30 mins and not responsive to intravenous fluids or hemodynamic deterioration for any duration requiring pressors or mechanical circulatory support, including IABP)
- •Cardiorespiratory arrest related to the current admission unless subject is extubated for \>24 hours with full neurologic recovery and hemodynamically stable.
- •Platelet count \<75,000 cells/mm3, bleeding diathesis or active bleeding, coagulopathy or unwilling to receive blood transfusions.
- •Pregnant or child-bearing potential unless negative pregnancy test within 1 week
- •Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device that has not reached its primary endpoint
- •Any medical or psychiatric condition such as dementia, alcoholism or substance abuse which may preclude informed consent or interfere with any of the study procedures, including follow-up visits
Outcomes
Primary Outcomes
Intrarenal Resistive Index (RI)
Time Frame: immediately and 24 hours after PCI
unitless, sonographic index measured in intrarenal arteries defined as (peak systolic velocity - end-diastolic velocity ) / peak systolic velocity.
Acute Kidney Injury
Time Frame: 48 hours respectively within 7 days
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
Secondary Outcomes
- Serum creatinine (mg/dl) and calculated creatinine clearance (ml/min) in relation to RI (Intrarenal Resistive Index) an Mehran score (unitiles)(maximum change 24 hours post intervention compared to baseline)
- α2macroglobulin urine concentration in relation to RI and Mehran score (unitiless).(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);(maximum change 24 hours post intervention compared to baseline)
- Reclassification of AKI Risk by determined cutoff value for RI compared to classic Mehran score(maximum change day 1 or day 2 post intervention compared to baseline)
- Length of stay in relation to RI and classic Mehran score.(Hospital admission until discharge (assessed up to maximum of 10 days))
- 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(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.(during Impella treatment (up to 14 days))