Protect Kidney Trial

High-risk Percutaneous Coronary Intervention Clinical 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

Status Recruiting

Clinical Trial 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).

Clinical Trial Description

n/a

Related Conditions & MeSH terms

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

• NCT number: NCT04321148
• Study type: Interventional
• Source: Heinrich-Heine University, Duesseldorf
• Contact: Ralf Westenfeld, MD
• Phone: +2118118800
• Email: ctu@med.uni-duesseldorf.de
• Status: Recruiting
• Phase: N/A
• Start date: January 24, 2020
• Completion date: December 2023