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

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ClinicalTrials.gov Identifier: NCT03920982
Recruitment Status : Recruiting
First Posted : April 19, 2019
Last Update Posted : February 8, 2023
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Septic Shock Uremic; Toxemia Mortality Diagnostic Test: Determination of the blood concentration of indoxyl sulfate (IS) Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Determination of the Prognostic Value Serum Concentration of Indoxyl Sulfate During Acute Kidney Injury in Septic Shock Patients: TOX-AKI Study
Actual Study Start Date : December 10, 2019
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arms and Interventions
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Intervention Details:
  • 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.

Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920982


Contacts
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Contact: Dimitri Titeca-Beauport, MD (33)322456411 titeca.dimitri@chu-amiens.fr
Contact: Julien Maizel, Pr (33)322087807 maizel.julien@chu-amiens.fr

Locations
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France
CHU Amiens Recruiting
Amiens, France, 80000
Contact: Dimitri Titeca-Beauport, MD    (33)322456411    titeca.dimitri@chu-amiens.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
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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
More Information
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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT03920982    
Other Study ID Numbers: PI2018_843_0050
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: February 8, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire, Amiens:
acute kidney injury
septic shock
uremic toxins
indoxyl sulfate
mortality
Additional relevant MeSH terms:
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Shock, Septic
Toxemia
Acute Kidney Injury
Shock
Wounds and Injuries
Pathologic Processes
Renal Insufficiency
 Kidney Diseases
Urologic Diseases
Sepsis
Infections
Systemic Inflammatory Response Syndrome
Inflammation