Status:
UNKNOWN
Protect Kidney Trial
Lead Sponsor:
Heinrich-Heine University, Duesseldorf
Collaborating Sponsors:
Profil Clinical Trials Coordination GmbH
Abiomed Inc.
Conditions:
Induced Acute Kidney Injury
High-risk Percutaneous Coronary Intervention
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
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 (PC...
Eligibility Criteria
Inclusion
- Signed and dated informed consent obtained before any trial-related activities.
- Patients aged 18-85 years (both inclusive) with clinical indication for coronary angiogram with potential high-risk PCI
- Patients at high risk for contrast induced acute kidney injury as indicated by a preliminary Mehran Score ≥ 10 (contrast media volume is assumed to be \< 100 ml)
Exclusion
- Previous participation in this trial. Participation is defined as randomized.
- Patients with contraindications to use of an Impella heart pump (mural thrombus in the left ventricle; presence of a mechanical aortic valve or aortic valve stenosis (equivalent orifice area of 1.5 cm2 or less); moderate to severe aortic insufficiency (echocardiographic assessment graded as ≥ +2); in whom severe peripheral arterial disease precluding placement of an Impella system)
- Patients where hemodynamic support is deemed potentially required for PCI as assessed by at least one physician
- Patients needing emergency percutaneous coronary intervention (e.g. STEMI patients)
- Patients with acute cardiogenic shock indicated by one of the following:
- Systolic blood pressure \< 90mmHg over 30 minutes or inotropic support needed to maintain blood pressure targets.
- Killip class III \& IV
- MCS already in place to maintain blood pressure and organ perfusion
- Patients with on-going resuscitation
- Unwitnessed cardiac arrest OR ≥30 minutes of CPR prior to screening OR any impairment in mental status, cognition, or any global or focal neurological deficit
- Patients on mechanical ventilation.
- Patients diagnosed with AKI within the last seven days prior to screening or incipient AKI. (In cases, where AKI cannot be ruled out as a cause for elevated serum creatine, a rise or fall above 30% of a second serum creatinine measurement obtained within 12 to 24 hours is indicative of AKI)
- Patients with an eGFR \< 20 ml/min/1.73 m²
- Suspected or known pregnancy
- Patients with comorbidity that in the Investigator's opinion would limit life expectancy to less than 6 months
- Patients with other medical, social, or psychological problems that, in the opinion of the Investigator, preclude them from undergoing Impella-protected PCI or the study-related procedures, evaluations, and follow-up.
- Patients with severe anemia as indicated by hemoglobin concentrations \< 8.5 g/dl at the time of screening.
- Patients who were exposed to contrast media in the last seven days prior to the time of screening
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
- Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device which has not reached its primary end point.
- Patients with contraindications against MRI-procedures (e.g. patients with pacemakers) are eligible for the study but will not participate in the BOLD-MRI assessment.
Key Trial Info
Start Date :
January 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT04321148
Start Date
January 24 2020
End Date
December 1 2023
Last Update
November 7 2022
Active Locations (1)
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1
Heinrich-Heine-University, Div. of Cardiology, Pulmonary Disease and Vascular Medicine
Düsseldorf, North Rhine-Westphalia, Germany, 40225