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

Primary Purpose

Acute Kidney Injury, Septic Shock, Uremic; Toxemia

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Determination of the blood concentration of indoxyl sulfate (IS)
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Kidney Injury focused on measuring acute kidney injury, septic shock, uremic toxins, indoxyl sulfate, mortality

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU AmiensRecruiting

Outcomes

Primary Outcome Measures

Mortality rate
Mortality of patients hospitalized for a septic shock who developed an acute kidney injury
Mortality rate
Mortality of patients hospitalized for a septic shock who developed an acute kidney injury

Secondary Outcome Measures

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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Blood concentration of Klotho
Blood concentration of Klotho will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Blood concentration of Klotho
Blood concentration of Klotho will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Blood concentration of Klotho
Blood concentration of Klotho will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Blood concentration of Klotho
Blood concentration of Klotho will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Blood concentration of Klotho
Blood concentration of Klotho will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Blood concentration of Klotho
Blood concentration of Klotho will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Blood concentration of Klotho
Blood concentration of Klotho will be measured in patients hospitalized for a septic shock who developed an acute kidney injury

Full Information

First Posted
April 16, 2019
Last Updated
February 7, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT03920982
Brief Title
Prognostic Value Serum Concentration of Indoxyl Sulfate During Acute Kidney Injury in Septic Shock Patients.
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 10, 2019 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury, Septic Shock, Uremic; Toxemia, Mortality
Keywords
acute kidney injury, septic shock, uremic toxins, indoxyl sulfate, mortality

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Diagnostic Test
Intervention Name(s)
Determination of the blood concentration of indoxyl sulfate (IS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mortality rate
Description
Mortality of patients hospitalized for a septic shock who developed an acute kidney injury
Time Frame
at day 28 after patient was admitted in intensive care unit
Title
Mortality rate
Description
Mortality of patients hospitalized for a septic shock who developed an acute kidney injury
Time Frame
at day 90 after patient was admitted in intensive care unit
Secondary Outcome Measure Information:
Title
Blood concentration of indoxyl sulfate
Description
Blood concentration of indoxyl sulfate will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Time Frame
at day 1 after patient was admitted in intensive care unit
Title
Blood concentration of indoxyl sulfate
Description
Blood concentration of indoxyl sulfate will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Time Frame
at day 2 after patient was admitted in intensive care unit
Title
Blood concentration of indoxyl sulfate
Description
Blood concentration of indoxyl sulfate will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Time Frame
at day 3 after patient was admitted in intensive care unit
Title
Blood concentration of indoxyl sulfate
Description
Blood concentration of indoxyl sulfate will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Time Frame
at day 4 after patient was admitted in intensive care unit
Title
Blood concentration of indoxyl sulfate
Description
Blood concentration of indoxyl sulfate will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Time Frame
at day 5 after patient was admitted in intensive care unit
Title
Blood concentration of indoxyl sulfate
Description
Blood concentration of indoxyl sulfate will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Time Frame
at day 6 after patient was admitted in intensive care unit
Title
Blood concentration of indoxyl sulfate
Description
Blood concentration of indoxyl sulfate will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Time Frame
at day 7 after patient was admitted in intensive care unit
Title
Blood concentration of para cresyl sulfate (PRS)
Description
Blood concentration of para cresyl sulfate (PRS) will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Time Frame
at day 1 after patient was admitted in intensive care unit
Title
Blood concentration of para cresyl sulfate (PRS)
Description
Blood concentration of para cresyl sulfate (PRS) will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Time Frame
at day 2 after patient was admitted in intensive care unit
Title
Blood concentration of para cresyl sulfate (PRS)
Description
Blood concentration of para cresyl sulfate (PRS) will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Time Frame
at day 3 after patient was admitted in intensive care unit
Title
Blood concentration of para cresyl sulfate (PRS)
Description
Blood concentration of para cresyl sulfate (PRS) will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Time Frame
at day 4 after patient was admitted in intensive care unit
Title
Blood concentration of para cresyl sulfate (PRS)
Description
Blood concentration of para cresyl sulfate (PRS) will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Time Frame
at day 5 after patient was admitted in intensive care unit
Title
Blood concentration of para cresyl sulfate (PRS)
Description
Blood concentration of para cresyl sulfate (PRS) will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Time Frame
at day 6 after patient was admitted in intensive care unit
Title
Blood concentration of para cresyl sulfate (PRS)
Description
Blood concentration of para cresyl sulfate (PRS) will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Time Frame
at day 7 after patient was admitted in intensive care unit
Title
Blood concentration of FGF 23 (Fibroblast Growth Factor 23)
Description
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
Time Frame
at day 1 after patient was admitted in intensive care unit
Title
Blood concentration of FGF 23 (Fibroblast Growth Factor 23)
Description
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
Time Frame
at day 2 after patient was admitted in intensive care unit
Title
Blood concentration of FGF 23 (Fibroblast Growth Factor 23)
Description
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
Time Frame
at day 3 after patient was admitted in intensive care unit
Title
Blood concentration of FGF 23 (Fibroblast Growth Factor 23)
Description
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
Time Frame
at day 4 after patient was admitted in intensive care unit
Title
Blood concentration of FGF 23 (Fibroblast Growth Factor 23)
Description
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
Time Frame
at day 5 after patient was admitted in intensive care unit
Title
Blood concentration of FGF 23 (Fibroblast Growth Factor 23)
Description
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
Time Frame
at day 6 after patient was admitted in intensive care unit
Title
Blood concentration of FGF 23 (Fibroblast Growth Factor 23)
Description
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
Time Frame
at day 7 after patient was admitted in intensive care unit
Title
Blood concentration of Klotho
Description
Blood concentration of Klotho will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Time Frame
at day 1 after patient was admitted in intensive care unit
Title
Blood concentration of Klotho
Description
Blood concentration of Klotho will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Time Frame
at day 2 after patient was admitted in intensive care unit
Title
Blood concentration of Klotho
Description
Blood concentration of Klotho will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Time Frame
at day 3 after patient was admitted in intensive care unit
Title
Blood concentration of Klotho
Description
Blood concentration of Klotho will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Time Frame
at day 4 after patient was admitted in intensive care unit
Title
Blood concentration of Klotho
Description
Blood concentration of Klotho will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Time Frame
at day 5 after patient was admitted in intensive care unit
Title
Blood concentration of Klotho
Description
Blood concentration of Klotho will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Time Frame
at day 6 after patient was admitted in intensive care unit
Title
Blood concentration of Klotho
Description
Blood concentration of Klotho will be measured in patients hospitalized for a septic shock who developed an acute kidney injury
Time Frame
at day 7 after patient was admitted in intensive care unit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dimitri Titeca-Beauport, MD
Phone
(33)322456411
Email
titeca.dimitri@chu-amiens.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Julien Maizel, Pr
Phone
(33)322087807
Email
maizel.julien@chu-amiens.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
michel slama, Pr
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Clement Brautt, MD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yoan Zerbib, MD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Youssef Bennis, Dr
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sandra Bodeau, Dr
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dimitri Titeca-Beauport, MD
Phone
(33)322456411
Email
titeca.dimitri@chu-amiens.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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