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Protect Kidney Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04321148
Recruitment Status : Recruiting
First Posted : March 25, 2020
Last Update Posted : November 7, 2022
Sponsor:
Collaborators:
Profil Clinical Trials Coordination GmbH
Abiomed Inc.
Information provided by (Responsible Party):
Heinrich-Heine University, Duesseldorf

Study Description
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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 (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).

Condition or disease Intervention/treatment Phase
Induced Acute Kidney Injury High-risk Percutaneous Coronary Intervention Procedure: standard of care PCI Procedure: Impella-protected PCI Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Study Comparing Impella Support Plus Optimal Medical Care Versus Optimal Medical Care Alone in Patients at High Risk for Contrast-induced Nephropathy Undergoing Elective Percutaneous Revascularization
Actual Study Start Date : January 24, 2020
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
standard of care PCI Procedure: standard of care PCI
optimal medical care PCI
Experimental: Impella-protected PCI Procedure: Impella-protected PCI
Impella-protected PCI


Outcome Measures
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Primary Outcome Measures :
  1. Incidence rate of Contrast-induced acute kidney injury (CI-AKI) [ Time Frame: 2 days after PCI ]
    Incidence rate of AKI (Acute Kidney Injury Criteria 1-3) over 2 days after PCI


Secondary Outcome Measures :
  1. Change in eGFR [ Time Frame: at day 1 and day 3 from baseline (pre-PCI) ]
  2. Incidence of acute kidney injury (AKIN Criteria 1-3) [ Time Frame: over 3 days after PCI ]
  3. Incidence of dialysis [ Time Frame: up to 6 months after PCI ]
    Incidence of dialysis during hospitalization and over 6 months after PCI

  4. Incidence of re-hospitalization for renal dysfunction [ Time Frame: 30 days and up to 6 months after PCI ]
    Incidence of re-hospitalization for renal dysfunction over 30 days and 6 months after PCI

  5. Mortality [ Time Frame: up to 6 months after PCI ]
    Mortality during hospital stay and over 6 months after PCI

  6. Length of hospital stay [ Time Frame: up to 3 days after PCI ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed and dated informed consent obtained before any trial-related activities.
  2. Patients aged 18-85 years (both inclusive) with clinical indication for coronary angiogram with potential high-risk PCI
  3. 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 Criteria:

  1. Previous participation in this trial. Participation is defined as randomized.
  2. 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)
  3. Patients where hemodynamic support is deemed potentially required for PCI as assessed by at least one physician
  4. Patients needing emergency percutaneous coronary intervention (e.g. STEMI patients)

  5. Patients with acute cardiogenic shock indicated by one of the following:

    1. Systolic blood pressure < 90mmHg over 30 minutes or inotropic support needed to maintain blood pressure targets.
    2. Killip class III & IV
    3. MCS already in place to maintain blood pressure and organ perfusion
  6. Patients with on-going resuscitation
  7. 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
  8. Patients on mechanical ventilation.
  9. 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)
  10. Patients with an eGFR < 20 ml/min/1.73 m²
  11. Suspected or known pregnancy
  12. Patients with comorbidity that in the Investigator's opinion would limit life expectancy to less than 6 months
  13. 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.
  14. Patients with severe anemia as indicated by hemoglobin concentrations < 8.5 g/dl at the time of screening.
  15. Patients who were exposed to contrast media in the last seven days prior to the time of screening
  16. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
  17. 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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04321148


Contacts
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Contact: Ralf Westenfeld, MD +2118118800 ctu@med.uni-duesseldorf.de
Contact: Lisa Dannenberg +211807924 ctu@med.uni-duesseldorf.de

Locations
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Germany
Heinrich-Heine-University, Div. of Cardiology, Pulmonary Disease and Vascular Medicine Recruiting
Dusseldorf, NRW, Germany, 40225
Contact: Ralf Westenfeld, MD    +49 211 81 18800    ralf.westenfeld@med.uni-duesseldorf.de   
Contact: M.A.         
Principal Investigator: Ralf Westenfeld, MD         
Sub-Investigator: Patrick Horn, MD         
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
Profil Clinical Trials Coordination GmbH
Abiomed Inc.
More Information
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Responsible Party: Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT04321148    
Other Study ID Numbers: 18-018
First Posted: March 25, 2020    Key Record Dates
Last Update Posted: November 7, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Heinrich-Heine University, Duesseldorf:
induced acute kidney injury
high-risk percutaneous coronary intervention
Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
 Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases