Protect Kidney Trial

NCT04321148 | Unknown

• 1 other identifier: 18-018
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

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).

Conditions

Induced Acute Kidney Injury; High-risk Percutaneous Coronary Intervention

Keywords

induced acute kidney injury; high-risk percutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

• Incidence rate of Contrast-induced acute kidney injury (CI-AKI)

  Incidence rate of AKI (Acute Kidney Injury Criteria 1-3) over 2 days after PCI

  2 days after PCI

Secondary Outcomes (6)

• Change in eGFR

  at day 1 and day 3 from baseline (pre-PCI)

• Incidence of acute kidney injury (AKIN Criteria 1-3)

  over 3 days after PCI

• Incidence of dialysis

  up to 6 months after PCI

• Incidence of re-hospitalization for renal dysfunction

  30 days and up to 6 months after PCI

• Mortality

  up to 6 months after PCI

Study Arms (2)

standard of care PCI

OTHER

Procedure: standard of care PCI

Impella-protected PCI

EXPERIMENTAL

Procedure: Impella-protected PCI

Interventions

standard of care PCI PROCEDURE

optimal medical care PCI

standard of care PCI

Impella-protected PCI PROCEDURE

Impella-protected PCI

Impella-protected PCI

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead
• Profil Clinical Trials Coordination GmbH: collaborator
• Abiomed Inc.: collaborator

Study Sites (1)

Heinrich-Heine-University, Div. of Cardiology, Pulmonary Disease and Vascular Medicine

Düsseldorf, North Rhine-Westphalia, 40225, Germany

RECRUITING

Central Study Contacts

Ralf Westenfeld, MD

CONTACT

+2118118800; ctu@med.uni-duesseldorf.de

Lisa Dannenberg

CONTACT

+211807924; ctu@med.uni-duesseldorf.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: March 25, 2020
• Study Start: January 24, 2020
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: November 7, 2022

Record last verified: 2022-11

Locations

DE (1)