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Protect Kidney Trial

NCT04321148 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2022-11-07

No results posted yet for this study

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

Interventions

PROCEDURE

standard of care PCI

optimal medical care PCI

PROCEDURE

Impella-protected PCI

Impella-protected PCI

Sponsors & Collaborators

  • Profil Clinical Trials Coordination GmbH

    collaborator UNKNOWN

  • Abiomed Inc.

    collaborator INDUSTRY

  • Heinrich-Heine University, Duesseldorf

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-24
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04321148 on ClinicalTrials.gov