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

NCT ID: NCT03920982

Last Updated: 2025-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-10

Study Completion Date

2023-07-11

Brief Summary

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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

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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.

Conditions

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Acute Kidney Injury Septic Shock Uremic; Toxemia Mortality

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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michel slama, Pr

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Clement Brautt, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Yoan Zerbib, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Youssef Bennis, Dr

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Sandra Bodeau, Dr

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Locations

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CHU Amiens

Amiens, , France

Site Status

Countries

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France

Other Identifiers

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PI2018_843_0050

Identifier Type: -

Identifier Source: org_study_id

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