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RecruitingNCT06320509

Interest of Urinary Oxygen Partial Pressure (PO2u) in Predicting the Onset or Recovery of Acute Renal Failure During Shock States - OXYpi Study

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
55 (estimated)
Sponsor
University Hospital, Angers · Other Government
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Shock state is defined as an acute, life-threatening, circulatory failure with impaired tissue oxygenation (or tissue hypoxia). The cause of the shock state can be septic, anaphylactic, hypovolemic or cardiogenic. Its management is based on etiological treatment and replacement of organ failures. Acute kidney injury (AKI) may be lead by renal hypoxia. Acute kidney injury is frequent in patients admitted to intensive care unit (ICU) and associated with an increased mortality. Serum creatinine is the reference biological marker in the diagnosis of Acute kidney injury. However, its use is limited by a delayed increase in plasma creatinine level in relation to the causal renal agression, at a time when renal tissue damage may already be established. Thus, the identification of a biological marker making it possible to estimate renal hypoxia continuously during a shock could allow us to identify early a situation at risk of evolving into Acute kidney injury. The renal medulla is vulnerable to tissue hypoxia with a risk of acute tubular necrosis. As in situ measurement of mPO2 is not possible in current practice in humans, several studies have shown a positive correlation between variations in mPO2/uPO2 and occurence of Acute kidney injury. In humans, studies have shown a significant association between the reduction in uPO2 in cardiac surgeries and the occurrence of postoperative Acute kidney injury. The aim of the study is to describe the association between uPO2 values and the onset of Acute kidney injury and/or the ocurrence of early recovery of renal function after Acute kidney injury. Any patient in shock (group A) or without shock and requiring urinary catheterization as part of treatment (group B) admitted to the Medical-Intensive Care Unit of Angers University Hospital is eligible for inclusion. After inclusion, a continuous uPO2 measuring probe is introduced with the placement of the urinary probe. uPO2 is collected continuously for the first 5 days of admission or until discharge from intensive care or removal of the urinary catheter. uPO2 is also measured by a gasometry on a urine sample on a multi-daily basis. Serum creatinine is collected every 12 hours (twice a day) and diuresis every two hours for 5 days.

Conditions

Interventions

TypeNameDescription
BIOLOGICALContinuous measurement of uPO2 (both groups)uPO2 is collected continuously for the first 5 days of admission or until discharge from intensive care or removal of the urinary catheter.

Timeline

Start date
2024-04-18
Primary completion
2027-10-18
Completion
2028-01-18
First posted
2024-03-20
Last updated
2025-11-20

Locations

2 sites across 1 country: France

Source: ClinicalTrials.gov record NCT06320509. Inclusion in this directory is not an endorsement.

Interest of Urinary Oxygen Partial Pressure (PO2u) in Predicting the Onset or Recovery of Acute Renal Failure During Sho (NCT06320509) · Clinical Trials Directory