Acute Kidney InjuryTOX-AKINCT03920982
Prognostic Value Serum Concentration of Indoxyl Sulfate During Acute Kidney Injury in Septic Shock Patients.
A study testing Determination of the blood concentration of indoxyl sulfate (IS) in people with Acute Kidney Injury and Septic Shock, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Septic Shock, Uremic; Toxemia
- What is being tested?
- Determination of the blood concentration of indoxyl sulfate (IS)
- How many people
- 114 participants
- Where
- 1 siteFrance
- Study dates
- 10 Dec 2019to 11 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Kidney Injury, Septic Shock, Uremic; Toxemia, Mortality
- Being tested
- Determination of the blood concentration of indoxyl sulfate (IS)
- Keywords
- acute kidney injury, septic shock, uremic toxins, indoxyl sulfate, mortality
- Medical subject headings
- Acute Kidney Injury, Shock, Septic, Toxemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Determination of the blood concentration of indoxyl sulfate (IS)Diagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate
Mortality of patients hospitalized for a septic shock who developed an acute kidney injury
Measured: 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
Measured: at day 90 after patient was admitted in intensive care unit
Secondary outcomes (28)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: at day 7 after patient was admitted in intensive care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start10 Dec 2019
- Primary completion1 Apr 2023
- Study completion11 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- michel slama, Pr, Principal investigator, CHU AmiensClement Brautt, MD, Principal investigator, CHU AmiensYoan Zerbib, MD, Principal investigator, CHU AmiensYoussef Bennis, Dr, Principal investigator, CHU AmiensSandra Bodeau, Dr, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03920982
- Sponsor's protocol ID
- PI2018_843_0050
- Acronym
- TOX-AKI
- Status last verified
- Jun 2025
- First submitted
- 16 Apr 2019
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Prognostic Value Serum Concentration of Indoxyl Sulfate During Acute Kidney Injury in Septic Shock Patients: TOX-AKI Study
- ClinicalTrials.gov ID
- NCT03920982
- Acronym / sponsor ID
- TOX-AKI / PI2018_843_0050
- Conditions
- Acute Kidney Injury, Septic Shock, Uremic; Toxemia, Mortality
- Keywords
- acute kidney injury, septic shock, uremic toxins, indoxyl sulfate, mortality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 11 Jul 2023 (actual)
- First posted
- 19 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | – |
Primary outcome
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
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
28 secondary outcomes
Blood concentration of indoxyl sulfate
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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 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)
Time frame: 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)
Time frame: 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)
Time frame: 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 Klotho
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: at day 7 after patient was admitted in intensive care unit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Acute Kidney Injury
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Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
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Acute Kidney Injury, Hypotension (MeSH: D007022)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
michel slama, Pr principal investigator
CHU Amiens
Clement Brautt, MD principal investigator
CHU Amiens
Yoan Zerbib, MD principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Determination of the blood concentration of indoxyl sulfate (IS) in people with Acute Kidney Injury and Septic Shock, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality rate (time frame: at day 28 after patient was admitted in intensive care unit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.