An interventional study of Continuous measurement of uPO2 (both groups) in Shock Circulatory, sponsored by University Hospital, Angers. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-20.
Sponsored by University Hospital, Angers · Not applicable, Interventional, and Screening
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.
916 studies on the registry are indexed under Shock; 176 are open to participants now.
This study's planned enrollment of 55 is below the median of 77 across 540 interventional studies indexed under Shock.
Browse Shock studies →University Hospital, Angers is the lead sponsor of 464 studies on the registry; 116 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
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
Insertion of bladder urine probe (Oxylite Pro ® device) and assessment of continuous uPO2
Biological: Continuous measurement of uPO2 (both groups)
Insertion of bladder urine probe (Oxylite Pro ® device) and assessment of continuous uPO2
Biological: Continuous 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.
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
Time frame: 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
Time frame: 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
Time frame: During the first 5 days after inclusion.
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).
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.
Time frame: 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).
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.
Time frame: 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
uPO2 is collected continuously for the first 5 days of admission or until discharge from intensive care or removal of the urinary catheter.
Time frame: 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
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
Time frame: 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
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
Time frame: During the first 5 days after inclusion or until discharge from intensive care or removal of the urinary catheter.
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.
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.
Time frame: During 1 hour from the beginning of the increase of norepinephrine doses.
In patients with need of introduction or increase of dobutamine, describe the evolution of uPO2 according to cardiac output or Mean Arterial Pressure evolution.
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
Time frame: During 1 hour from the introduction or increase of dobutamine.
Evaluation the correlation between uPO2 assessed by Oxylite Pro® device and urinary gasometry.
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.
In patients without shock, describe the evolution of uPO2 during the first 5 days.
uPO2 is collected continuously for the first 5 days of admission or until discharge from intensive care or removal of the urinary catheter.
Time frame: During the first 5 days after inclusion or until discharge from intensive care or removal of the urinary catheter.
In patients with septic shock, build up a biocollection, enabling further analyses to be carried out at a later date
Build up a biocollection by taking additional blood and urine samples
Time frame: During the first 5 days after inclusion or until discharge from intensive care or removal of the urinary catheter.
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
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
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Angers