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Recruiting NCT05659589

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

No phase Interventional Acute Kidney Injury Uremic; Toxemia Vascular Dysfunction Cardiac Dysfunction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: blood sample.
Who it may be relevant to
Registry conditions: Acute Kidney Injury, Uremic; Toxemia, Vascular Dysfunction, Cardiac Dysfunction. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other 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.

Primary outcome measures

  • Change of pulse wave velocity (PWV) measurement from baseline [Time frame: at 3 months]
Secondary outcome measures (8)
  • Correlation between Para-cresyl Sulfate (PCS) concentration and PWV [Time frame: 3 months]
  • Correlation between Fibroblast Growth Factor 23 (FGF23) concentration and PWV [Time frame: 3 months]
  • Correlation between Fibroblast Growth Factor 23 (FGF23) concentration and arterial pressure measurement [Time frame: 3 months]
  • Correlation between Fibroblast Growth Factor 23 (FGF23) concentration and cardiac diastolic function [Time frame: 3 months]
  • Correlation between IS concentration and arterial pressure measurement [Time frame: 3 months]
  • Correlation between IS concentration and cardiac diastolic function [Time frame: 3 months]
  • Correlation between Para-cresyl Sulfate (PCS) concentration and arterial pressure measurement [Time frame: 3 months]
  • Correlation between Para-cresyl Sulfate (PCS) concentration and cardiac diastolic function [Time frame: 3 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Double blind
Primary purpose
Other

Study locations

France · 1 center
  • Amiens hospital — Amiens

Identifiers

NCT: NCT05659589 · PI2021_843_0143

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗