PuO2 in RenalGuard Pilot Study

Launched by SAHLGRENSKA UNIVERSITY HOSPITAL · Mar 14, 2025

Keywords

ClinConnect Summary

The PuO2 in RenalGuard (PURE) study is a clinical trial designed to see if a special system called RenalGuard can help improve kidney oxygen levels in patients undergoing heart surgery with a heart-lung machine. The study will compare two groups: one group will receive standard care, while the other group will use the RenalGuard system during and after surgery. Researchers will measure kidney oxygen levels by checking urine samples for 24 hours, starting right after anesthesia begins.

To be eligible for this study, participants need to be at least 18 years old and scheduled for heart surgery that requires a heart-lung machine. They must also have a certain level of kidney function. However, those who are already on certain medications for kidney issues or have serious kidney problems will not be included. If you join the study, you'll be randomly assigned to one of the two groups and monitored closely during your surgery and recovery to help the researchers understand how well the RenalGuard system works compared to standard care. This trial is still in the planning stage and is not yet recruiting participants.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients ≥18 years of age
• • scheduled for cardiac surgery with normothermic CPB
• • Estimated glomerular filtration rate ≥50 ml/min as assessed by the CKD-EPI formula
• Exclusion Criteria:
• • Patient receiving furosemide at a dose\>100 mg/day orally (or the equivalent dose of an alternative loop diuretic) in the last week
• • Patient who cannot be urethrally catheterized for any reason
• • Patient already dialysis dependent
• • Known or suspected AKI (KDIGO criteria) at the time of screening
• • Any condition which, in the judgement of the investigator, might increase the risk to the patient