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Prognostic Value Serum Concentration of Indoxyl Sulfate During Acute Kidney Injury in Septic Shock Patients.

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03920982
Acronym
TOX-AKI
Enrollment
114
Registered
2019-04-19
Start date
2019-12-10
Completion date
2023-07-11
Last updated
2025-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury, Mortality, Septic Shock, Uremic; Toxemia

Keywords

acute kidney injury, septic shock, uremic toxins, indoxyl sulfate, mortality

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.

Interventions

DIAGNOSTIC_TESTDetermination 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.

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mortality rateat day 28 after patient was admitted in intensive care unitMortality of patients hospitalized for a septic shock who developed an acute kidney injury

Secondary

MeasureTime frameDescription
Blood concentration of indoxyl sulfateat day 1 after patient was admitted in intensive care unitBlood 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)at day 1 after patient was admitted in intensive care unitBlood 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)at day 1 after patient was admitted in intensive care unitBlood 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 Klothoat day 1 after patient was admitted in intensive care unitBlood concentration of Klotho will be measured in patients hospitalized for a septic shock who developed an acute kidney injury

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026