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

N/ARecruitingNCT06320509

University Hospital, Angers55 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SCREENING

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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

Time frame: During the first 5 days after inclusion.

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).

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.