Shock Circulatory
Conditions
Keywords
Acute kidney injury, Continuous urine oxygen tension, Circulatory failure, Shock
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.
Interventions
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.
Sponsors
University Hospital, Angers
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A - For patients without acute kidney injury at inclusion, the occurence of acute kidney injury and its severity according to the KDIGO criteria | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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 |
| 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. | 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 |
| 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. | 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. |
| In patients with need of introduction or increase of dobutamine, describe the evolution of uPO2 according to cardiac output or Mean Arterial Pressure evolution. | 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 |
| 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. | 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. |
| In patients without shock, describe the evolution of uPO2 during the first 5 days. | 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. |
| In patients with septic shock, build up a biocollection, enabling further analyses to be carried out at a later date | 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 |
| 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. | 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 | 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 | — |
| Evaluation the correlation between uPO2 assessed by Oxylite Pro® device and urinary gasometry. | 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. |
| 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. | 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. |
| 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. | uPO2 is collected continuously for the first 5 days of admission or until discharge from intensive care or removal of the urinary catheter. |
Countries
France
Contacts
Primary ContactNicolas FAGE, PhD
Backup ContactDRCI CHU Angers Promotion Internea
Outcome results
None listed