Protect Kidney Trial

• ClinicalTrials.gov Identifier: NCT04321148
• Recruitment Status: Recruiting
• First Posted: March 25, 2020
• Last Update Posted: November 7, 2022
• Sponsor: Heinrich-Heine University, Duesseldorf
• Collaborators: Profil Clinical Trials Coordination GmbH; Abiomed Inc.
• Information provided by (Responsible Party): Heinrich-Heine University, Duesseldorf

Tracking Information

• First Submitted Date: March 16, 2020
• First Posted Date: March 25, 2020
• Last Update Posted Date: November 7, 2022
• Actual Study Start Date: January 24, 2020
• Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 24, 2020)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 24, 2020)

• 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 [ Time Frame: up to 6 months after PCI ]
  Incidence of dialysis during hospitalization and over 6 months after PCI
• 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
• Mortality [ Time Frame: up to 6 months after PCI ]
  Mortality during hospital stay and over 6 months after PCI
• Length of hospital stay [ Time Frame: up to 3 days after PCI ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Protect Kidney Trial
• 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
• 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Induced Acute Kidney Injury
• High-risk Percutaneous Coronary Intervention

Intervention

• Procedure: standard of care PCI
  optimal medical care PCI
• Procedure: Impella-protected PCI
  Impella-protected PCI

Study Arms

• standard of care PCI
  Intervention: Procedure: standard of care PCI
• Experimental: Impella-protected PCI
  Intervention: Procedure: Impella-protected PCI

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 24, 2020): 224
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2023
• Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Ralf Westenfeld, MD; +2118118800; ctu@med.uni-duesseldorf.de

Contact: Lisa Dannenberg; +211807924; ctu@med.uni-duesseldorf.de

• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT04321148
• Other Study ID Numbers: 18-018
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Heinrich-Heine University, Duesseldorf
• Original Responsible Party: Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf, Principle Investigator
• Current Study Sponsor: Heinrich-Heine University, Duesseldorf
• Original Study Sponsor: Same as current

Collaborators

• Profil Clinical Trials Coordination GmbH
• Abiomed Inc.

• Investigators: Not Provided
• PRS Account: Heinrich-Heine University, Duesseldorf
• Verification Date: November 2022