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Protect Kidney Trial | Clinical Trials | Clareo Health

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Protect Kidney Trial

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

NCT04321148•Heinrich-Heine University, Duesseldorf

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

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
+11 more criteria

Locations (1)

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

Düsseldorf, North Rhine-Westphalia, Germany

Key Dates

Start Date

January 24, 2020

Primary Completion Date

December 1, 2023

Completion Date

December 1, 2023

Last Updated

November 7, 2022

Enrollment

224

ESTIMATED participants

Conditions

Induced Acute Kidney InjuryHigh-risk Percutaneous Coronary Intervention

Interventions

standard of care PCI

PROCEDURE

Impella-protected PCI

PROCEDURE

Contacts

Ralf Westenfeld, MD

CONTACT

+2118118800 ctu@med.uni-duesseldorf.de

Lisa Dannenberg

CONTACT

+211807924 ctu@med.uni-duesseldorf.de

ELEVATE High-Risk PCI Pivotal Study

NCT07001332

High-Risk Percutaneous Coronary Intervention (High-risk PCI)

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RECRUITING

Use of Flozins (Empagliflozin/Dapagliflozin) for Prevention of AKI

NCT07231939

Coronary Artery DiseaseAcute Kidney Injury+2 more

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 7, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Protect Kidney Trial

Inclusion Criteria

Exclusion Criteria

ELEVATE High-Risk PCI Pivotal Study

Use of Flozins (Empagliflozin/Dapagliflozin) for Prevention of AKI

Interventional Left Ventricular Assist System for PCI in CHIP Patients

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