NCT04321148

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 224 (estimated)
• Sponsor: Heinrich-Heine University, Duesseldorf · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
PROCEDURE	standard of care PCI	optimal medical care PCI
PROCEDURE	Impella-protected PCI	Impella-protected PCI

Timeline

• Start date: 2020-01-24
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2020-03-25
• Last updated: 2022-11-07

Locations

1 site across 1 country: Germany