TOX-AKI: Prognostic Value Serum Concentration of Indoxyl Sulfate During Acute Kidney Injury in Septic Shock Patients.

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Recruiting

CT.gov ID

NCT03920982

Collaborator

(none)

Enrollment

Location

30.7

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury Septic Shock Uremic; Toxemia Mortality	Diagnostic Test: Determination of the blood concentration of indoxyl sulfate (IS)	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Determination of the Prognostic Value Serum Concentration of Indoxyl Sulfate During Acute Kidney Injury in Septic Shock Patients: TOX-AKI Study

Actual Study Start Date :

Dec 10, 2019

Anticipated Primary Completion Date :

Apr 1, 2022

Anticipated Study Completion Date :

Jul 1, 2022

Outcome Measures

Primary Outcome Measures

Mortality rate [at day 28 after patient was admitted in intensive care unit]
Mortality of patients hospitalized for a septic shock who developed an acute kidney injury
Mortality rate [at day 90 after patient was admitted in intensive care unit]
Mortality of patients hospitalized for a septic shock who developed an acute kidney injury

Secondary Outcome Measures

Blood concentration of indoxyl sulfate [at day 1 after patient was admitted in intensive care unit]
Blood concentration of indoxyl sulfate will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Blood concentration of indoxyl sulfate [at day 2 after patient was admitted in intensive care unit]
Blood concentration of indoxyl sulfate will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Blood concentration of indoxyl sulfate [at day 3 after patient was admitted in intensive care unit]
Blood concentration of indoxyl sulfate will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Blood concentration of indoxyl sulfate [at day 4 after patient was admitted in intensive care unit]
Blood concentration of indoxyl sulfate will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Blood concentration of indoxyl sulfate [at day 5 after patient was admitted in intensive care unit]
Blood concentration of indoxyl sulfate will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Blood concentration of indoxyl sulfate [at day 6 after patient was admitted in intensive care unit]
Blood concentration of indoxyl sulfate will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Blood concentration of indoxyl sulfate [at day 7 after patient was admitted in intensive care unit]
Blood concentration of indoxyl sulfate will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Blood concentration of para cresyl sulfate (PRS) [at day 1 after patient was admitted in intensive care unit]
Blood concentration of para cresyl sulfate (PRS) will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Blood concentration of para cresyl sulfate (PRS) [at day 2 after patient was admitted in intensive care unit]
Blood concentration of para cresyl sulfate (PRS) will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Blood concentration of para cresyl sulfate (PRS) [at day 3 after patient was admitted in intensive care unit]
Blood concentration of para cresyl sulfate (PRS) will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Blood concentration of para cresyl sulfate (PRS) [at day 4 after patient was admitted in intensive care unit]
Blood concentration of para cresyl sulfate (PRS) will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Blood concentration of para cresyl sulfate (PRS) [at day 5 after patient was admitted in intensive care unit]
Blood concentration of para cresyl sulfate (PRS) will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Blood concentration of para cresyl sulfate (PRS) [at day 6 after patient was admitted in intensive care unit]
Blood concentration of para cresyl sulfate (PRS) will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Blood concentration of para cresyl sulfate (PRS) [at day 7 after patient was admitted in intensive care unit]
Blood concentration of para cresyl sulfate (PRS) will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Blood concentration of FGF 23 (Fibroblast Growth Factor 23) [at day 1 after patient was admitted in intensive care unit]
Blood concentration of FGF 23 (Fibroblast Growth Factor 23) will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Blood concentration of FGF 23 (Fibroblast Growth Factor 23) [at day 2 after patient was admitted in intensive care unit]
Blood concentration of FGF 23 (Fibroblast Growth Factor 23) will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Blood concentration of FGF 23 (Fibroblast Growth Factor 23) [at day 3 after patient was admitted in intensive care unit]
Blood concentration of FGF 23 (Fibroblast Growth Factor 23) will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Blood concentration of FGF 23 (Fibroblast Growth Factor 23) [at day 4 after patient was admitted in intensive care unit]
Blood concentration of FGF 23 (Fibroblast Growth Factor 23) will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Blood concentration of FGF 23 (Fibroblast Growth Factor 23) [at day 5 after patient was admitted in intensive care unit]
Blood concentration of FGF 23 (Fibroblast Growth Factor 23) will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Blood concentration of FGF 23 (Fibroblast Growth Factor 23) [at day 6 after patient was admitted in intensive care unit]
Blood concentration of FGF 23 (Fibroblast Growth Factor 23) will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Blood concentration of FGF 23 (Fibroblast Growth Factor 23) [at day 7 after patient was admitted in intensive care unit]
Blood concentration of FGF 23 (Fibroblast Growth Factor 23) will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Blood concentration of Klotho [at day 1 after patient was admitted in intensive care unit]
Blood concentration of Klotho will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Blood concentration of Klotho [at day 2 after patient was admitted in intensive care unit]
Blood concentration of Klotho will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Blood concentration of Klotho [at day 3 after patient was admitted in intensive care unit]
Blood concentration of Klotho will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Blood concentration of Klotho [at day 4 after patient was admitted in intensive care unit]
Blood concentration of Klotho will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Blood concentration of Klotho [at day 5 after patient was admitted in intensive care unit]
Blood concentration of Klotho will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Blood concentration of Klotho [at day 6 after patient was admitted in intensive care unit]
Blood concentration of Klotho will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Blood concentration of Klotho [at day 7 after patient was admitted in intensive care unit]
Blood concentration of Klotho will be measured in patients hospitalized for a septic shock who developed an acute kidney injury

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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