Prognostic Role of the Uremic Toxin Indoxyl Sulfate on Vascular and Cardiac Functions During Acute Kidney Injury

NCT05659589 | Recruiting DMC

• 1 other identifier: PI2021_843_0143
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

Acute kidney injury (AKI) is a frequent disease in conventional hospital departments and in intensive care units. It's associated with a high risk to develop chronic kidney disease (CKD), even after a single small AKI episode. It's also associated with an important morbi-mortality, particularly cardiovascular (CV). Some studies have already showed a link between AKI and CV risk but pathologic mechanisms implicated are still unknown. In AKI and CKD, numerous substances, called uremic toxins (UT) are accumulating in blood. In CKD, those toxins, and particularly Indoxyl sulfate (IS), are known to have cardiac and vascular deleterious consequences. However, in AKI, whether acute accumulation of UT may trigger CV complications is unknown. The purpose of this study is that during AKI, a high UT concentration, in particular IS, would be associated with early vascular and cardiac dysfunctions that can be characterized by the persistence of an accelerated pulse wave velocity (PWV). The main objective is to evaluate the correlation between UT concentrations (especially IS) and arterial stiffness (PWV measurement) at three months of an AKI episode in conventional hospital departments and in the intensive care unit of nephrology.

Conditions

Acute Kidney Injury; Uremic; Toxemia; Vascular Dysfunction; Cardiac Dysfunction; Cardiovascular Prognosis

Keywords

Acute Kidney Injury; Uremic; Toxemia; vascular dysfunction; cardiac dysfunction; cardiovascular prognosis

Outcome Measures

Primary Outcomes (1)

• Change of pulse wave velocity (PWV) measurement from baseline

  at 3 months

Secondary Outcomes (8)

• Correlation between Para-cresyl Sulfate (PCS) concentration and PWV

  3 months

• Correlation between Fibroblast Growth Factor 23 (FGF23) concentration and PWV

  3 months

• Correlation between Fibroblast Growth Factor 23 (FGF23) concentration and arterial pressure measurement

  3 months

• Correlation between Fibroblast Growth Factor 23 (FGF23) concentration and cardiac diastolic function

  3 months

• Correlation between IS concentration and arterial pressure measurement

  3 months

Interventions

blood sample OTHER

Blood sample withdrawal will be done and serum creatinine, IS, PCS, FGF-23, Angiopoietin-2, VCAM-1, E-Selectin and Troponin will be measured.

Eligibility Criteria

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

You may qualify if:

• Age over 18 years old.
• Patients hospitalized in conventional hospital departments and in intensive care units of nephrology.
• Patients with moderate to severe AKI (KDIGO 2 or 3) without dialysis.
• AKI from functional or organic aetiology

You may not qualify if:

• Patients with severe CKD (GFR\<45ml/min/1.73 m2) or with kidney transplants.
• Patients with AKI from septic or obstructive aetiology.
• Patients with AKI from toxic aetiology whose toxic would be also responsable of cardia toxicity.
• Patients with sepsis or blood inflammation.
• Patients with severe chronic cardia dysfunction.
• Patients with arrhythmia or complete heart block.
• Patients with peripheral artery occlusive disease.
• Pregnancy.
• Patients on palliative care.

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

Amiens hospital

Amiens, 80000, France

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury; Toxemia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infections

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Pauline Caillard, MD

CONTACT

03 22 45 58 66; caillard.pauline@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: December 21, 2022
• Study Start: December 13, 2022
• Primary Completion: September 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)