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

June 5, 2025 updated by: Centre Hospitalier Universitaire, Amiens

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
114

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80000
        • CHU Amiens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mortality rate
Time Frame: 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
at day 28 after patient was admitted in intensive care unit
Mortality rate
Time Frame: 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
at day 90 after patient was admitted in intensive care unit

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blood concentration of indoxyl sulfate
Time Frame: 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
at day 1 after patient was admitted in intensive care unit
Blood concentration of indoxyl sulfate
Time Frame: 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
at day 2 after patient was admitted in intensive care unit
Blood concentration of indoxyl sulfate
Time Frame: 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
at day 3 after patient was admitted in intensive care unit
Blood concentration of indoxyl sulfate
Time Frame: 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
at day 4 after patient was admitted in intensive care unit
Blood concentration of indoxyl sulfate
Time Frame: 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
at day 5 after patient was admitted in intensive care unit
Blood concentration of indoxyl sulfate
Time Frame: 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
at day 6 after patient was admitted in intensive care unit
Blood concentration of indoxyl sulfate
Time Frame: 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
at day 7 after patient was admitted in intensive care unit
Blood concentration of para cresyl sulfate (PRS)
Time Frame: 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
at day 1 after patient was admitted in intensive care unit
Blood concentration of para cresyl sulfate (PRS)
Time Frame: 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
at day 2 after patient was admitted in intensive care unit
Blood concentration of para cresyl sulfate (PRS)
Time Frame: 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
at day 3 after patient was admitted in intensive care unit
Blood concentration of para cresyl sulfate (PRS)
Time Frame: 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
at day 4 after patient was admitted in intensive care unit
Blood concentration of para cresyl sulfate (PRS)
Time Frame: 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
at day 5 after patient was admitted in intensive care unit
Blood concentration of para cresyl sulfate (PRS)
Time Frame: 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
at day 6 after patient was admitted in intensive care unit
Blood concentration of para cresyl sulfate (PRS)
Time Frame: 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
at day 7 after patient was admitted in intensive care unit
Blood concentration of FGF 23 (Fibroblast Growth Factor 23)
Time Frame: 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
at day 1 after patient was admitted in intensive care unit
Blood concentration of FGF 23 (Fibroblast Growth Factor 23)
Time Frame: 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
at day 2 after patient was admitted in intensive care unit
Blood concentration of FGF 23 (Fibroblast Growth Factor 23)
Time Frame: 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
at day 3 after patient was admitted in intensive care unit
Blood concentration of FGF 23 (Fibroblast Growth Factor 23)
Time Frame: 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
at day 4 after patient was admitted in intensive care unit
Blood concentration of FGF 23 (Fibroblast Growth Factor 23)
Time Frame: 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
at day 5 after patient was admitted in intensive care unit
Blood concentration of FGF 23 (Fibroblast Growth Factor 23)
Time Frame: 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
at day 6 after patient was admitted in intensive care unit
Blood concentration of FGF 23 (Fibroblast Growth Factor 23)
Time Frame: 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
at day 7 after patient was admitted in intensive care unit
Blood concentration of Klotho
Time Frame: 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
at day 1 after patient was admitted in intensive care unit
Blood concentration of Klotho
Time Frame: 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
at day 2 after patient was admitted in intensive care unit
Blood concentration of Klotho
Time Frame: 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
at day 3 after patient was admitted in intensive care unit
Blood concentration of Klotho
Time Frame: 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
at day 4 after patient was admitted in intensive care unit
Blood concentration of Klotho
Time Frame: 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
at day 5 after patient was admitted in intensive care unit
Blood concentration of Klotho
Time Frame: 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
at day 6 after patient was admitted in intensive care unit
Blood concentration of Klotho
Time Frame: 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
at day 7 after patient was admitted in intensive care unit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire, Amiens

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: michel slama, Pr, CHU Amiens
  • Principal Investigator: Clement Brautt, MD, CHU Amiens
  • Principal Investigator: Yoan Zerbib, MD, CHU Amiens
  • Principal Investigator: Youssef Bennis, Dr, CHU Amiens
  • Principal Investigator: Sandra Bodeau, Dr, CHU Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 10, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 11, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 16, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 19, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings