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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Mortality; Septic Shock; Acute Kidney Injury; Uremic; Toxemia
• Intervention / Treatment: Diagnostic test: Determination of the blood concentration of indoxyl sulfate (IS)

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 Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80000
    • Recruiting
    • CHU Amiens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 10, 2019
• Primary Completion (ANTICIPATED): April 1, 2023
• Study Completion (ANTICIPATED): July 1, 2023

Study Registration Dates

• First Submitted: April 16, 2019
• First Submitted That Met QC Criteria: April 16, 2019
• First Posted (ACTUAL): April 19, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: septic shock; acute kidney injury; mortality; uremic toxins; indoxyl sulfate
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Kidney Diseases; Urologic Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Renal Insufficiency; Sepsis; Toxemia; Shock, Septic; Wounds and Injuries; Shock; Acute Kidney Injury
• Other Study ID Numbers: PI2018_843_0050

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No