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PuO2 in RenalGuard Pilot Study

NCT06886191 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-03-20

No results posted yet for this study

Summary

The PuO2 in RenalGuard (PURE) study is planned as a single center, randomized controlled pilot study comparing renal oxygenation during cardiac surgery with cardiopulmonary bypass (CPB) with or without balanced forced diuresis using the RenalGuard (RG) system.

Renal oxygenation will be assessed by urine oxygen tension, continuously measured by optodes placed through the urine catheter. Measurements will start after induction of anesthesia and continue for 24 hours.

In total, 30 patients will be randomized 1:1 to RG or standard of care (SOC) during cardiac surgery with CPB. In the RG group, the forced diuresis with neutral fluid balance will be maintained from before the start of surgery until 3 hours after weaning from CPB.

The primary endpoint is the group difference (RG vs SOC) in delta PuO2, defined as the change in mean PuO2 from baseline to the last 5-minute period at 45 minutes after start of CPB.

The secondary endpoints include

1. Group difference in mean PuO2 before, during and after CPB
2. Group difference in time weighted area under the curve for PuO2
3. Group differences in renal near infrared spectroscopy (NIRS) before, during and after CPB
4. Group difference in urine and blood biochemistry including renal biomarkers
5. Group difference in urine output and fluid balance during surgery and first postoperative day
6. Group differences in postoperative AKI according to the KDIGO criteria
7. Time (minutes) with puO2 ≤ 15 and ≤ 10 mmHg during and after CPB
8. Dynamics of PuO2 during the early postoperative phase

Patients ≥18 years scheduled for cardiac surgery with CPB with estimated glomerular filtration rate ≥50 ml/min are eligible for inclusion. Exclusion criteria include patients on higher doses of furosemide, patients with AKI or under renal replacement therapy.

Patients will be analyzed according to study group. In patients where hemofiltration has been used during CPB, control group patients who has received furosemide and patients in the RG group who do not reach target urine flow will be excluded from the main analysis but will be included in a separate analysis.

Conditions

  • Cardiac Surgery Subjects

Interventions

DEVICE

RenalGuard Therapy

Fluid management system, which weighs urine and controls intravenous administration of crystalloid solution.

Sponsors & Collaborators

  • Sahlgrenska University Hospital

    lead OTHER

Principal Investigators

  • Lukas Lannemyr Lannemyr, MD, PhD · Institute of Clinical Sciences, Dept of Anesthesia and Intensive Care, Sahlgrenska Academy, Gothenburg University. Gothenburg, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-03-17
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

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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 NCT06886191 on ClinicalTrials.gov