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

NCT ID: NCT05659589

Last Updated: 2025-05-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-13
• Study Completion Date: 2026-06-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Interventions

blood sample

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Amiens hospital

Amiens, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Pauline Caillard, MD

Role: CONTACT

caillard.pauline@chu-amiens.fr

03 22 45 58 66

Facility Contacts

Pauline Caillard, MD

Role: primary

caillard.pauline@chu-amiens.fr

03 22 45 58 66

Other Identifiers

PI2021_843_0143

Identifier Type: -

Identifier Source: org_study_id