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

NCT03920982 | Completed

• 1 other identifier: PI2018_843_0050
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Mortality rate

  Mortality of patients hospitalized for a septic shock who developed an acute kidney injury

  at day 28 after patient was admitted in intensive care unit

• Mortality rate

  Mortality of patients hospitalized for a septic shock who developed an acute kidney injury

  at day 90 after patient was admitted in intensive care unit

Secondary Outcomes (28)

• 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

Interventions

Determination of the blood concentration of indoxyl sulfate (IS) DIAGNOSTIC_TEST

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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80000, France

Location

MeSH Terms

Conditions

Acute Kidney Injury; Shock, Septic; Toxemia

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: April 19, 2019
• Study Start: December 10, 2019
• Primary Completion: April 1, 2023
• Study Completion: July 11, 2023
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)