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

NCT06320509 | Recruiting

• 1 other identifier: 49RC23_0417
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 2

Brief 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

Shock Circulatory

Keywords

Acute kidney injury; Continuous urine oxygen tension; Circulatory failure; Shock

Outcome Measures

Primary Outcomes (3)

• A - For patients without acute kidney injury at inclusion, the occurence of acute kidney injury and its severity according to the KDIGO criteria

  A KDIGO Criteria: Increase in serum creatinine ≥ 26.5 µmol/L during the 48 hours following inclusion Or an increase of ≥ 1.5 fold the admission serum creatinine during the first 5 days Or Diuresis \< 0.5 mL/kg/h for 6 hours during the first 5 days

  During the first 5 days after inclusion.

• B - For patients with acute kidney injury occurring during the first 3 days following inclusion, early recovery is defined by the return to pre-shock renal function 48 hours from the start of acute kidney injury

  A KDIGO Criteria: Increase in serum creatinine ≥ 26.5 µmol/L during the 48 hours following inclusion Or an increase of ≥ 1.5 fold the admission serum creatinine during the first 5 days Or Diuresis \< 0.5 mL/kg/h for 6 hours during the first 5 days

  During the first 5 days after inclusion.

• C - For patients with acute kidney injury occurring at inclusion, describe the evolution of PO2u values in patients with worsening renal function

  A KDIGO Criteria: Increase in serum creatinine ≥ 26.5 µmol/L during the 48 hours following inclusion Or an increase of ≥ 1.5 fold the admission serum creatinine during the first 5 days Or Diuresis \< 0.5 mL/kg/h for 6 hours during the first 5 days

  During the first 5 days after inclusion.

Secondary Outcomes (12)

• In patients in group A, assess the association between uPO2 variation and acute kidney injury, defined by KDIGO criteria, in different subgroups (septic shock, sepsis without norepinephrine, non-septic shock).

  During the first 5 days after inclusion.

• In patients in group A with newly occured acute kidney injury, assess the association between uPO2 variation and recovery of acute kidney injury in different subgroups (septic shock, sepsis without norepinephrine, non-septic shock).

  During the first 5 days after inclusion.

• In patients in group A, assess the evolution of uPO2 during the first 5 days in patients with and without sepsis

  During the first 5 days after inclusion or until discharge from intensive care or removal of the urinary catheter.

• Describe the variation of uPO2 according to evolution of Mean Arterial Pressure and cardiac output in the subgroup of patients who received fluid expansion

  During the first 5 days after inclusion or until discharge from intensive care or removal of the urinary catheter.

• Describe the variation of uPO2 according to evolution of Mean Arterial Pressure and cardiac output in the subgroup of patients who received blood transfusion

  During the first 5 days after inclusion or until discharge from intensive care or removal of the urinary catheter.

Study Arms (2)

Shock population

OTHER

Insertion of bladder urine probe (Oxylite Pro ® device) and assessment of continuous uPO2

Biological: Continuous measurement of uPO2 (both groups)

Without Shock Population

OTHER

Insertion of bladder urine probe (Oxylite Pro ® device) and assessment of continuous uPO2

Biological: Continuous measurement of uPO2 (both groups)

Interventions

Continuous measurement of uPO2 (both groups) BIOLOGICAL

uPO2 is collected continuously for the first 5 days of admission or until discharge from intensive care or removal of the urinary catheter.

Shock population; Without Shock Population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Group A:
• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (2)

University Hospital of Angers

Angers, 49933, France

RECRUITING

Bicêtre Hospital

Le Kremlin-Bicêtre, France

NOT YET RECRUITING

MeSH Terms

Conditions

Shock; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Nicolas FAGE, PhD

CONTACT

2 41 35 58 65; nicolas.fage@chu-angers.fr

DRCI CHU Angers Promotion Internea

CONTACT

2 41 35 36 37; DRCI-promotion-interne@chu-angers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 20, 2024
• Study Start: April 18, 2024
• Primary Completion (Estimated): October 18, 2027
• Study Completion (Estimated): January 18, 2028
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)