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Clinical Trials/NCT03920982
NCT03920982
Completed
Not Applicable

Determination of the Prognostic Value Serum Concentration of Indoxyl Sulfate During Acute Kidney Injury in Septic Shock Patients: TOX-AKI Study

Centre Hospitalier Universitaire, Amiens1 site in 1 country114 target enrollmentDecember 10, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Kidney Injury
Sponsor
Centre Hospitalier Universitaire, Amiens
Enrollment
114
Locations
1
Primary Endpoint
Mortality rate
Status
Completed
Last Updated
10 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 10, 2019
End Date
July 11, 2023
Last Updated
10 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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 Outcomes

  • Blood concentration of Klotho(at day 7 after patient was admitted in intensive care unit)
  • Blood concentration of para cresyl sulfate (PRS)(at day 7 after patient was admitted in intensive care unit)
  • Blood concentration of FGF 23 (Fibroblast Growth Factor 23)(at day 7 after patient was admitted in intensive care unit)
  • Blood concentration of indoxyl sulfate(at day 7 after patient was admitted in intensive care unit)

Study Sites (1)

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