Status:
RECRUITING
IntraRenal HEmoDynamics to IntegraTE CA-AKI Risk and Monitor NephroprotectiIoN by ImpElla Support.
Lead Sponsor:
Heinrich-Heine University, Duesseldorf
Collaborating Sponsors:
German Heart Center
Charite University, Berlin, Germany
Conditions:
Chronic Kidney Diseases
Renal Failure
Eligibility:
All Genders
18-90 years
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, r...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
- Any non-cardiac condition with life expectancy \<1 years (e.g., cirrhosis, cancer not in remission, etc.)
- Subject belongs to a vulnerable population (defined as individuals with mental disability, persons in nursing homes, impoverished persons, homeless persons, nomads, refugees and those permanently incapable of giving informed consent; vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces and persons kept in detention)
Key Trial Info
Start Date :
October 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
550 Patients enrolled
Trial Details
Trial ID
NCT06599424
Start Date
October 1 2023
End Date
June 1 2025
Last Update
September 19 2024
Active Locations (2)
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1
Department of Cardiology, Angiology and Intensive Care Medicine Campus at German Heart Center Charite
Berlin, Germany
2
Division of Cardiology, Pulmonary Disease and Vascular Medicine at University Hospital Duesseldorf
Düsseldorf, Germany, 40225