Shock CirculatoryOXYpiNCT06320509
Interest of Urinary Oxygen Partial Pressure (PO2u) in Predicting the Onset or Recovery of Acute Renal Failure During Shock States - OXYpi Study
A study testing Continuous measurement of uPO2 (both groups) in people with Shock Circulatory, run by University Hospital, Angers at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock Circulatory
- What is being tested?
- Continuous measurement of uPO2 (both groups)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 2 sitesFrance
- Study dates
- 18 Apr 2024to 18 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
DRCI CHU Angers Promotion Internea contact
France2 sites, 2 recruiting
- Recruiting
University Hospital of Angers
Angers, 49933
Nicolas Fage, PhD
- Not yet recruiting
Bicêtre Hospital
Le Kremlin-Bicêtre
Xavier Monnet, xavier.monnet@aphp.fr
About this 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.
- Conditions
- Shock Circulatory
- Being tested
- Continuous measurement of uPO2 (both groups)
- Keywords
- Acute kidney injury, Continuous urine oxygen tension, Circulatory failure, Shock
- Medical subject headings
- Shock, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Shock population | Other | Insertion of bladder urine probe (Oxylite Pro ® device) and assessment of continuous uPO2 Receives: Biological: Continuous measurement of uPO2 (both groups) |
| Without Shock Population | Other | Insertion of bladder urine probe (Oxylite Pro ® device) and assessment of continuous uPO2 Receives: Biological: Continuous measurement of uPO2 (both groups) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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).
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start18 Apr 2024
- Primary completion18 Oct 2027 (estimated)
- Study completion18 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shock CirculatoryStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06320509
- Sponsor's protocol ID
- 49RC23_0417
- Acronym
- OXYpi
- Status last verified
- Nov 2025
- First submitted
- 27 Feb 2024
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Urinary Oxygen Partial Pressure (PO2u) in Predicting the Onset or Recovery of Acute Renal Failure During Shock States - OXYpi Study
- ClinicalTrials.gov ID
- NCT06320509
- Acronym / sponsor ID
- OXYpi / 49RC23_0417
- Conditions
- Shock Circulatory
- Keywords
- Acute kidney injury, Continuous urine oxygen tension, Circulatory failure, Shock
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 18 Apr 2024 (actual)
- Primary completion
- 18 Oct 2027 (estimated)
- Study completion
- 18 Jan 2028 (estimated)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shock population | Other | Biological: Continuous measurement of uPO2 (both groups)Insertion of bladder urine probe (Oxylite Pro ® device) and assessment of continuous uPO2 |
| Without Shock Population | Other | Biological: Continuous measurement of uPO2 (both groups)Insertion of bladder urine probe (Oxylite Pro ® device) and assessment of continuous uPO2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Biological | Shock population, Without Shock Population |
Primary outcome
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
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
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
12 secondary outcomes
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.
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.
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.
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.
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.
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.
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.
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.
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
DRCI CHU Angers Promotion Internea contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous measurement of uPO2 (both groups) in people with Shock Circulatory, run by University Hospital, Angers at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas FAGE, PhD (2 41 35 58 65 ext. +33, nicolas.fage@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.