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出境医 / 临床实验 / Prognostic Value Serum Concentration of Indoxyl Sulfate During Acute Kidney Injury in Septic Shock Patients. (TOX-AKI)

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

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.

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
Layout table for study information
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 2022
Estimated Study Completion Date : July 2022
Arms and Interventions
Outcome Measures
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
Contacts and Locations
Tracking Information
First Submitted Date  ICMJE April 16, 2019
First Posted Date  ICMJE April 19, 2019
Last Update Posted Date July 20, 2020
Actual Study Start Date  ICMJE December 10, 2019
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2019)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2019)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prognostic Value Serum Concentration of Indoxyl Sulfate During Acute Kidney Injury in Septic Shock Patients.
Official Title  ICMJE Determination of the Prognostic Value Serum Concentration of Indoxyl Sulfate During Acute Kidney Injury in Septic Shock Patients: TOX-AKI Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Acute Kidney Injury
  • Septic Shock
  • Uremic; Toxemia
  • Mortality
Intervention  ICMJE 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.
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 16, 2019) 		90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2022
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dimitri Titeca-Beauport, MD (33)322456411 titeca.dimitri@chu-amiens.fr
Contact: Julien Maizel, Pr (33)322087807 maizel.julien@chu-amiens.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03920982
Other Study ID Numbers  ICMJE PI2018_843_0050
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Centre Hospitalier Universitaire, Amiens
Study Sponsor  ICMJE Centre Hospitalier Universitaire, Amiens
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Centre Hospitalier Universitaire, Amiens
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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