Measuring urine oxygen levels to predict kidney failure during shock
Interest of Urinary Oxygen Partial Pressure (PO2u) in Predicting the Onset or Recovery of Acute Renal Failure During Shock States - OXYpi Study
This study is testing if measuring oxygen levels in urine can help doctors predict kidney problems in patients who are in shock.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 55 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Angers Government |
| Locations | 2 sites (Angers and 1 other locations) |
| Trial ID | NCT06320509 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of continuous urinary oxygen partial pressure (PO2u) measurements to predict the onset or recovery of acute kidney injury (AKI) in patients experiencing shock states. Shock can arise from various causes, including septic or hypovolemic conditions, and is characterized by impaired tissue oxygenation. By identifying renal hypoxia early through PO2u, the study aims to improve the management of patients in intensive care units (ICUs) and potentially reduce mortality associated with AKI. The study includes patients with shock and those without, both requiring urinary catheterization.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older admitted to the ICU with or without shock requiring urinary catheterization.
Not a fit: Patients with preexisting chronic kidney disease, those on dialysis, or those with indications for immediate renal replacement therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier detection and intervention for acute kidney injury, improving patient outcomes in critical care settings.
How similar studies have performed: While the use of urinary oxygen measurements is a novel approach, similar studies have shown promise in identifying renal hypoxia and its implications for kidney injury.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria : Group A: \- Patient admitted to Intensive Care Unit with a shock state defined by arterial hypotension requiring vascular filling and/or introduction of catecholamines - Age ≥ 18 years - Affiliated or benificiary of a social security scheme - Consent of the patient or a relative, or inclusion as part of an emergency inclusion procedure Group B: * Patient admitted to Intensive Care Unit without shock * Requiring urinary catheterization as part of routine care * Age ≥ 18 years * Affiliated or benificiary of a social security scheme * Consent of the patient or a relative, or inclusion as part of an emergency inclusion procedure Exclusion Criteria: \- Preexisting chronic kidney disease (CKD) (GFR \< 60 mL/min/1,73 m2 according to MDRD) - Chronic dialysis and/or kidney transplant - Anuria - Indication for renal replacement therapy (life-threatening hyperkaliemia, severe metabolic acidosis pH \< 7,15, uremia \> 40 mmol/L, pulmonary edema resistant to diuretics) - Patient requiring an extracorporeal life support (ECLS) - Pregnant, breastfeeding or parturient woman - Patient deprived of liberty by judicial or administrative decision - Patient under psychiatric care - Patient under legal protection measures
Where this trial is running
Angers and 1 other locations
- University Hospital of Angers — Angers, France (Recruiting)
- Bicêtre Hospital — Le Kremlin-Bicêtre, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Nicolas FAGE, PhD
- Email: nicolas.fage@chu-angers.fr
- Phone: 2 41 35 58 65
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.