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NCT Number: NCT06320509

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

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.

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Key information

Conditions

Shock Circulatory Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Shock Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Angers, Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: During the first 5 days after inclusion.

    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

  2. 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

    Time frame: During the first 5 days after inclusion.

    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

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

    Time frame: During the first 5 days after inclusion.

    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

Secondary outcomes

  1. 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).

    Time frame: During the first 5 days after inclusion.

    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.

    Sepsis is defined as a life-threatening organ dysfunction caused by suspected or confirmed infection.

    Septic shock is defined as a sepsis with need of norepinephrine.

  2. 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).

    Time frame: During the first 5 days after inclusion.

    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.

    Sepsis is defined as a life-threatening organ dysfunction caused by suspected or confirmed infection.

    Septic shock is defined as a sepsis with need of norepinephrine.

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

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

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

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

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

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

    Mean Arterial Pressure is measured continuously with an in situ arterial line and cardiac output is measured invasively by transpulmonary thermodilution or a pulmonary arterial catheterization, or non-invasively by transthoraci echocardiography

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

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

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

    Mean Arterial Pressure is measured continuously with an in situ arterial line and cardiac output is measured invasively by transpulmonary thermodilution or a pulmonary arterial catheterization, or non-invasively by transthoracic echocardiography

  6. In patients with need of increasing Mean Arterial Pressure by increase of norepinephrine doses, describe the evolution of uPO2 according to Mean Arterial Pressure evolution.

    Time frame: During 1 hour from the beginning of the increase of norepinephrine doses.

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

    Mean Arterial Pressure is measured continuously with an in situ arterial line.

  7. In patients with need of introduction or increase of dobutamine, describe the evolution of uPO2 according to cardiac output or Mean Arterial Pressure evolution.

    Time frame: During 1 hour from the introduction or increase of dobutamine.

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

    Mean Arterial Pressure is measured continuously with an in situ arterial line and cardiac output is measured invasively by transpulmonary thermodilution or a pulmonary arterial catheterization, or non-invasively by transthoraci echocardiography

  8. Evaluation the correlation between uPO2 assessed by Oxylite Pro® device and urinary gasometry.

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

    Evaluation the correlation between uPO2 assessed by Oxylite Pro® device and urinary gasometry.

  9. In patients without shock, describe the evolution of uPO2 during the first 5 days.

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

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

  10. In patients with septic shock, build up a biocollection, enabling further analyses to be carried out at a later date

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

    Build up a biocollection by taking additional blood and urine samples

  11. In patients who, during their treatment, have an indication for the introduction or increase of vasopressin: assess the impact of introducing/increasing vasopressin on PO2u.

    Time frame: During 20 minutes from the beginning of the increase of vasopressine doses

  12. For patients whose skin recoloration time and PO2u are assessed before and after a procedure, describe the correlation between changes in PO2u and skin recoloration time during each procedure

    Time frame: During 1 hour from the beginning of the increase of norepinephrine doses, during 1 hour from the introduction or increase of dobutamine, during 20 minutes from the beginning of the increase of vasopressine doses

Study contacts

Contact information is provided by the study sponsor or research team.

DRCI CHU Angers Promotion Internea

CONTACT

[email protected]

2 41 35 36 37 ext. +33

Nicolas FAGE, PhD

CONTACT

[email protected]

2 41 35 58 65 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Acronym: OXYpi

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Mar 20, 2024
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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