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NCT Number: NCT05659589

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

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.

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Key information

Conditions

Acute Kidney Injury Cardiac Dysfunction Cardiovascular Prognosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Kidney Diseases Male Urogenital Diseases Renal Insufficiency Toxemia Uremic; Toxemia Urogenital Diseases Urologic Diseases Vascular Dysfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change of pulse wave velocity (PWV) measurement from baseline

    Time frame: at 3 months

Secondary outcomes

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

    Time frame: 3 months

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

    Time frame: 3 months

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

    Time frame: 3 months

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

    Time frame: 3 months

  5. Correlation between IS concentration and arterial pressure measurement

    Time frame: 3 months

  6. Correlation between IS concentration and cardiac diastolic function

    Time frame: 3 months

  7. Correlation between Para-cresyl Sulfate (PCS) concentration and arterial pressure measurement

    Time frame: 3 months

  8. Correlation between Para-cresyl Sulfate (PCS) concentration and cardiac diastolic function

    Time frame: 3 months

Study contacts

Contact information is provided by the study sponsor or research team.

Pauline Caillard, MD

CONTACT

[email protected]

03 22 45 58 66

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: VASC-AKI

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Dec 21, 2022
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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