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RecruitingNCT05659589VASC-AKIUpdated May 28, 2025

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

An interventional study of blood sample in Acute Kidney Injury, Uremic; Toxemia and Vascular Dysfunction, sponsored by Centre Hospitalier Universitaire, Amiens. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-28.

Sponsored by Centre Hospitalier Universitaire, Amiens · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 2 months ago, but the record still lists the study as recruiting.
  • Started Dec 2022; still recruiting 3 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
105
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • Acute Kidney Injury
  • Uremic; Toxemia
  • vascular dysfunction
  • cardiac dysfunction
  • cardiovascular prognosis
03

In context

Acute Kidney Injury

1,691 studies on the registry are indexed under Acute Kidney Injury; 395 are open to participants now.

This study's planned enrollment of 105 is close to the median of 100 across 817 interventional studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

Centre Hospitalier Universitaire, Amiens is the lead sponsor of 586 studies on the registry; 185 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients with severe CKD (\<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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
105 participants (estimated)

Interventions

  • Otherblood 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.

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05659589
Responsible party
Sponsor
First posted
Dec 21, 2022
Start date
Dec 13, 2022
Primary completion
Sep 2025 (estimated)
Completion
Jun 2026 (estimated)
Last update
May 28, 2025

Study contacts

Pauline Caillard, MD
Contact
caillard.pauline@chu-amiens.fr
03 22 45 58 66

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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