Clinical trial NCT03920982: Prognostic Value Serum Concentration of Indoxyl Sulfate During Acute Kidney Injury in Septic Shock Patients.
Official title: Determination of the Prognostic Value Serum Concentration of Indoxyl Sulfate During Acute Kidney Injury in Septic Shock Patients: TOX-AKI Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Kidney Injury
Septic Shock
Uremic; Toxemia
Mortality
Keywords: acute kidney injury
septic shock
uremic toxins
indoxyl sulfate
mortality
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2019-04-19
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The development of acute kidney injury (AKI) during septic shock is frequent and is associated with a high mortality rate. The reason of this increased mortality despite the use of renal replacement therapy is still unknown. The deleterious effects of uremic toxins (solutes accumulating with the loss of kidney function) has risen for the last decade in chronic kidney disease patients. Among those solutes, indoxyl sulfate (IS) is associated with the development of cardiovascular complications and impairment of immune response. The role of uremic toxins and particularly IS in the prognostic of septic kidney injury is unknown. The investigators propose to analyze the relation between the serum concentration of IS and the mortality of patients hospitalized for a septic shock who developed an AKI.

Detailed description: During chronic kidney disease the uremic toxins have been widely described as potential harmful solutes targeting the cardiovascular system, immunologic system, endothelium and bone metabolism. However, nothing is known about the potential accumulation and pejorative effects of those uremic toxins during AKI (Acute Kidney Injury). The objective of this study is to explore the role of the uremic toxins and specially IS (Indoxyl Sulfate) in the mortality of patients hospitalized for a septic shock and AKI. This study will also describe for the first time the kinetic of the blood concentration of different uremic toxins and their relation with the mortality and the kidney function.

Eligibility criteria: Inclusion Criteria:

* Patients over 18 years hospitalized in the medical intensive care unit in Amiens university hospital
* Presence of a septic shock (sepsis associated with a persistent hypotension after fluid resuscitation and requiring vasopressors to maintain MAP \> 65 mmHg and/or serum lactate level \> 2 mmol/ L).
* Evidence of AKI (KDIGO \> or equal1) in the 72 hours following the admission in the ICU: diuresis \< 0.5ml / kg / h for 6 to12 hours or \> or equal 1.5 to1.9 fold increase or \> 26.5 micromol / l in serum creatinine from baseline
* signed written informed consent form
* covered by national health insurance

Exclusion Criteria:

* known pre hospitalization (in the last 3 month preceding the hospitalization) advanced chronic kidney disease defined by an estimated glomerular filtration rate \< 60 ml / min / 1.73m square
* Pregnancy
* Presence or strong clinical suspicion of renal obstruction
* Moribund patients (expected life \< 48h)
* Cardio respiratory arrest
* Hemoglobin level below 10 g / dl

Primary outcomes:
measure: Mortality rate
timeFrame: at day 28 after patient was admitted in intensive care unit
measure: Mortality rate
timeFrame: at day 90 after patient was admitted in intensive care unit
Secondary outcomes:
measure: Blood concentration of indoxyl sulfate
timeFrame: at day 1 after patient was admitted in intensive care unit
measure: Blood concentration of indoxyl sulfate
timeFrame: at day 2 after patient was admitted in intensive care unit
measure: Blood concentration of indoxyl sulfate
timeFrame: at day 3 after patient was admitted in intensive care unit
measure: Blood concentration of indoxyl sulfate
timeFrame: at day 4 after patient was admitted in intensive care unit
measure: Blood concentration of indoxyl sulfate
timeFrame: at day 5 after patient was admitted in intensive care unit
measure: Blood concentration of indoxyl sulfate
timeFrame: at day 6 after patient was admitted in intensive care unit
measure: Blood concentration of indoxyl sulfate
timeFrame: at day 7 after patient was admitted in intensive care unit
measure: Blood concentration of para cresyl sulfate (PRS)
timeFrame: at day 1 after patient was admitted in intensive care unit
measure: Blood concentration of para cresyl sulfate (PRS)
timeFrame: at day 2 after patient was admitted in intensive care unit
measure: Blood concentration of para cresyl sulfate (PRS)
timeFrame: at day 3 after patient was admitted in intensive care unit
measure: Blood concentration of para cresyl sulfate (PRS)
timeFrame: at day 4 after patient was admitted in intensive care unit
measure: Blood concentration of para cresyl sulfate (PRS)
timeFrame: at day 5 after patient was admitted in intensive care unit
measure: Blood concentration of para cresyl sulfate (PRS)
timeFrame: at day 6 after patient was admitted in intensive care unit
measure: Blood concentration of para cresyl sulfate (PRS)
timeFrame: at day 7 after patient was admitted in intensive care unit
measure: Blood concentration of FGF 23 (Fibroblast Growth Factor 23)
timeFrame: at day 1 after patient was admitted in intensive care unit
measure: Blood concentration of FGF 23 (Fibroblast Growth Factor 23)
timeFrame: at day 2 after patient was admitted in intensive care unit
measure: Blood concentration of FGF 23 (Fibroblast Growth Factor 23)
timeFrame: at day 3 after patient was admitted in intensive care unit
measure: Blood concentration of FGF 23 (Fibroblast Growth Factor 23)
timeFrame: at day 4 after patient was admitted in intensive care unit
measure: Blood concentration of FGF 23 (Fibroblast Growth Factor 23)
timeFrame: at day 5 after patient was admitted in intensive care unit
measure: Blood concentration of FGF 23 (Fibroblast Growth Factor 23)
timeFrame: at day 6 after patient was admitted in intensive care unit
measure: Blood concentration of FGF 23 (Fibroblast Growth Factor 23)
timeFrame: at day 7 after patient was admitted in intensive care unit
measure: Blood concentration of Klotho
timeFrame: at day 1 after patient was admitted in intensive care unit
measure: Blood concentration of Klotho
timeFrame: at day 2 after patient was admitted in intensive care unit
measure: Blood concentration of Klotho
timeFrame: at day 3 after patient was admitted in intensive care unit
measure: Blood concentration of Klotho
timeFrame: at day 4 after patient was admitted in intensive care unit
measure: Blood concentration of Klotho
timeFrame: at day 5 after patient was admitted in intensive care unit
measure: Blood concentration of Klotho
timeFrame: at day 6 after patient was admitted in intensive care unit
measure: Blood concentration of Klotho
timeFrame: at day 7 after patient was admitted in intensive care unit
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: michel slama, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: Clement Brautt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: Yoan Zerbib, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: Youssef Bennis, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: Sandra Bodeau, Dr
role: PRINCIPAL_INVESTIGATOR
References: