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NCT03920982 Clinical Trial

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

Acute Kidney Injury Clinical Trial

— TOX-AKI  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03920982
Other study ID # PI2018_843_0050
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 10, 2019
Est. completion date July 2023

Study information
Verified date February 2023
Source Centre Hospitalier Universitaire, Amiens
Contact Dimitri Titeca-Beauport, MD
Phone (33)322456411
Email titeca.dimitri@chu-amiens.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 90
Est. completion date July 2023
Est. primary completion date April 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Determination of the blood concentration of indoxyl sulfate (IS)
IS concentration will be determined in blood of patients with septic shock and acute kidney injury. IS blood concentration will be done every day during 7 first days after patient will be admitted in intensive care unit. Relation between IS peak serum concentration and mortality at day 28 will be determined.

Locations
Country Name City State
France CHU Amiens Amiens

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mortality rate Mortality of patients hospitalized for a septic shock who developed an acute kidney injury at day 28 after patient was admitted in intensive care unit
Primary Mortality rate Mortality of patients hospitalized for a septic shock who developed an acute kidney injury at day 90 after patient was admitted in intensive care unit
Secondary Blood concentration of indoxyl sulfate Blood concentration of indoxyl sulfate will be measured in patients hospitalized for a septic shock who developed an acute kidney injury at day 1 after patient was admitted in intensive care unit
Secondary Blood concentration of indoxyl sulfate Blood concentration of indoxyl sulfate will be measured in patients hospitalized for a septic shock who developed an acute kidney injury at day 2 after patient was admitted in intensive care unit
Secondary Blood concentration of indoxyl sulfate Blood concentration of indoxyl sulfate will be measured in patients hospitalized for a septic shock who developed an acute kidney injury at day 3 after patient was admitted in intensive care unit
Secondary Blood concentration of indoxyl sulfate Blood concentration of indoxyl sulfate will be measured in patients hospitalized for a septic shock who developed an acute kidney injury at day 4 after patient was admitted in intensive care unit
Secondary Blood concentration of indoxyl sulfate Blood concentration of indoxyl sulfate will be measured in patients hospitalized for a septic shock who developed an acute kidney injury at day 5 after patient was admitted in intensive care unit
Secondary Blood concentration of indoxyl sulfate Blood concentration of indoxyl sulfate will be measured in patients hospitalized for a septic shock who developed an acute kidney injury at day 6 after patient was admitted in intensive care unit
Secondary Blood concentration of indoxyl sulfate Blood concentration of indoxyl sulfate will be measured in patients hospitalized for a septic shock who developed an acute kidney injury at day 7 after patient was admitted in intensive care unit
Secondary Blood concentration of para cresyl sulfate (PRS) Blood concentration of para cresyl sulfate (PRS) will be measured in patients hospitalized for a septic shock who developed an acute kidney injury at day 1 after patient was admitted in intensive care unit
Secondary Blood concentration of para cresyl sulfate (PRS) Blood concentration of para cresyl sulfate (PRS) will be measured in patients hospitalized for a septic shock who developed an acute kidney injury at day 2 after patient was admitted in intensive care unit
Secondary Blood concentration of para cresyl sulfate (PRS) Blood concentration of para cresyl sulfate (PRS) will be measured in patients hospitalized for a septic shock who developed an acute kidney injury at day 3 after patient was admitted in intensive care unit
Secondary Blood concentration of para cresyl sulfate (PRS) Blood concentration of para cresyl sulfate (PRS) will be measured in patients hospitalized for a septic shock who developed an acute kidney injury at day 4 after patient was admitted in intensive care unit
Secondary Blood concentration of para cresyl sulfate (PRS) Blood concentration of para cresyl sulfate (PRS) will be measured in patients hospitalized for a septic shock who developed an acute kidney injury at day 5 after patient was admitted in intensive care unit
Secondary Blood concentration of para cresyl sulfate (PRS) Blood concentration of para cresyl sulfate (PRS) will be measured in patients hospitalized for a septic shock who developed an acute kidney injury at day 6 after patient was admitted in intensive care unit
Secondary Blood concentration of para cresyl sulfate (PRS) Blood concentration of para cresyl sulfate (PRS) will be measured in patients hospitalized for a septic shock who developed an acute kidney injury at day 7 after patient was admitted in intensive care unit
Secondary Blood concentration of FGF 23 (Fibroblast Growth Factor 23) 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 at day 1 after patient was admitted in intensive care unit
Secondary Blood concentration of FGF 23 (Fibroblast Growth Factor 23) 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 at day 2 after patient was admitted in intensive care unit
Secondary Blood concentration of FGF 23 (Fibroblast Growth Factor 23) 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 at day 3 after patient was admitted in intensive care unit
Secondary Blood concentration of FGF 23 (Fibroblast Growth Factor 23) 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 at day 4 after patient was admitted in intensive care unit
Secondary Blood concentration of FGF 23 (Fibroblast Growth Factor 23) 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 at day 5 after patient was admitted in intensive care unit
Secondary Blood concentration of FGF 23 (Fibroblast Growth Factor 23) 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 at day 6 after patient was admitted in intensive care unit
Secondary Blood concentration of FGF 23 (Fibroblast Growth Factor 23) 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 at day 7 after patient was admitted in intensive care unit
Secondary Blood concentration of Klotho Blood concentration of Klotho will be measured in patients hospitalized for a septic shock who developed an acute kidney injury at day 1 after patient was admitted in intensive care unit
Secondary Blood concentration of Klotho Blood concentration of Klotho will be measured in patients hospitalized for a septic shock who developed an acute kidney injury at day 2 after patient was admitted in intensive care unit
Secondary Blood concentration of Klotho Blood concentration of Klotho will be measured in patients hospitalized for a septic shock who developed an acute kidney injury at day 3 after patient was admitted in intensive care unit
Secondary Blood concentration of Klotho Blood concentration of Klotho will be measured in patients hospitalized for a septic shock who developed an acute kidney injury at day 4 after patient was admitted in intensive care unit
Secondary Blood concentration of Klotho Blood concentration of Klotho will be measured in patients hospitalized for a septic shock who developed an acute kidney injury at day 5 after patient was admitted in intensive care unit
Secondary Blood concentration of Klotho Blood concentration of Klotho will be measured in patients hospitalized for a septic shock who developed an acute kidney injury at day 6 after patient was admitted in intensive care unit
Secondary Blood concentration of Klotho Blood concentration of Klotho will be measured in patients hospitalized for a septic shock who developed an acute kidney injury at day 7 after patient was admitted in intensive care unit
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