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

Sponsors

Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Source Centre Hospitalier Universitaire, Amiens
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.

Overall Status Recruiting
Start Date December 10, 2019
Completion Date July 2022
Primary Completion Date April 2022
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Mortality rate at day 28 after patient was admitted in intensive care unit
Mortality rate at day 90 after patient was admitted in intensive care unit
Secondary Outcome
Measure Time Frame
Blood concentration of indoxyl sulfate at day 1 after patient was admitted in intensive care unit
Blood concentration of indoxyl sulfate at day 2 after patient was admitted in intensive care unit
Blood concentration of indoxyl sulfate at day 3 after patient was admitted in intensive care unit
Blood concentration of indoxyl sulfate at day 4 after patient was admitted in intensive care unit
Blood concentration of indoxyl sulfate at day 5 after patient was admitted in intensive care unit
Blood concentration of indoxyl sulfate at day 6 after patient was admitted in intensive care unit
Blood concentration of indoxyl sulfate at day 7 after patient was admitted in intensive care unit
Blood concentration of para cresyl sulfate (PRS) at day 1 after patient was admitted in intensive care unit
Blood concentration of para cresyl sulfate (PRS) at day 2 after patient was admitted in intensive care unit
Blood concentration of para cresyl sulfate (PRS) at day 3 after patient was admitted in intensive care unit
Blood concentration of para cresyl sulfate (PRS) at day 4 after patient was admitted in intensive care unit
Blood concentration of para cresyl sulfate (PRS) at day 5 after patient was admitted in intensive care unit
Blood concentration of para cresyl sulfate (PRS) at day 6 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 1 after patient was admitted in intensive care unit
Blood concentration of FGF 23 (Fibroblast Growth Factor 23) at day 2 after patient was admitted in intensive care unit
Blood concentration of FGF 23 (Fibroblast Growth Factor 23) at day 3 after patient was admitted in intensive care unit
Blood concentration of FGF 23 (Fibroblast Growth Factor 23) at day 4 after patient was admitted in intensive care unit
Blood concentration of FGF 23 (Fibroblast Growth Factor 23) at day 5 after patient was admitted in intensive care unit
Blood concentration of FGF 23 (Fibroblast Growth Factor 23) at day 6 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 Klotho at day 1 after patient was admitted in intensive care unit
Blood concentration of Klotho at day 2 after patient was admitted in intensive care unit
Blood concentration of Klotho at day 3 after patient was admitted in intensive care unit
Blood concentration of Klotho at day 4 after patient was admitted in intensive care unit
Blood concentration of Klotho at day 5 after patient was admitted in intensive care unit
Blood concentration of Klotho at day 6 after patient was admitted in intensive care unit
Blood concentration of Klotho at day 7 after patient was admitted in intensive care unit
Enrollment 90
Condition
Intervention

Intervention Type: Diagnostic Test

Intervention Name: Determination of the blood concentration of indoxyl sulfate (IS)

Description: 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.

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Overall Contact

Last Name: Dimitri Titeca-Beauport, MD

Phone: (33)322456411

Email: [email protected]

Location
Facility: Status: Contact: CHU Amiens Dimitri Titeca-Beauport, MD (33)322456411 [email protected]
Location Countries

France

Verification Date

July 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Acronym TOX-AKI
Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov