PuO2 in RenalGuard Pilot Study

NCT ID: NCT06886191

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-17
• Study Completion Date: 2026-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

RenalGuard (RG)

The RG system is used to ensure neutral (0) fluid balance while maintaining a urine flow >200 ml/hour. Urine output is replaced 1:1 with Plasmolyte solution. In patients randomized to RG, therapy is initiated after baseline measurements but before the start of surgery.

If baseline urine flow is < 200 ml/hour, a bolus dose of furosemide (20 mg iv) is given, and additional furosemide bolus and/or titration of continuous furosemide infusion may be given to maintain urine flow rate >200ml/hour.

After completed surgery, RG therapy continues until 3 hours after weaning from CPB

Group Type: EXPERIMENTAL

RenalGuard Therapy

Intervention Type: DEVICE

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

Standard of Care

Conduct of cardiopulmonary bypass will be done according to local clinical practice

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

RenalGuard Therapy

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sahlgrenska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lukas Lannemyr

Consultant Anesthesiologist, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lukas Lannemyr Lannemyr, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute of Clinical Sciences, Dept of Anesthesia and Intensive Care, Sahlgrenska Academy, Gothenburg University. Gothenburg, Sweden

Central Contacts

Lukas Lannemyr Lannemyr, MD, PhD

Role: CONTACT

lukas.lannemyr@vgregion.se

0046 708350971

Other Identifiers

PUREstudy

Identifier Type: -

Identifier Source: org_study_id