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

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Recruiting

CT.gov ID

NCT05659589

Collaborator

(none)

150

Enrollment

Location

35.6

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury Uremic; Toxemia Vascular Dysfunction Cardiac Dysfunction Cardiovascular Prognosis	Other: blood sample	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

Dec 13, 2022

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2025

Outcome Measures

Primary Outcome Measures

Change of pulse wave velocity (PWV) measurement from baseline [at 3 months]

Secondary Outcome Measures

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]
Correlation between IS concentration and cardiac diastolic function [3 months]
Correlation between Para-cresyl Sulfate (PCS) concentration and arterial pressure measurement [3 months]
Correlation between Para-cresyl Sulfate (PCS) concentration and cardiac diastolic function [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.