Acute Kidney InjuryVASC-AKINCT05659589
Prognostic Role of the Uremic Toxin Indoxyl Sulfate on Vascular and Cardiac Functions During Acute Kidney Injury
A study testing blood sample in people with Acute Kidney Injury and Uremic; Toxemia, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Uremic; Toxemia, Vascular Dysfunction
- What is being tested?
- blood sample
- How many people
- 105 participants
- Where
- 1 siteFrance
- Study dates
- 13 Dec 2022to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- Patients with peripheral artery occlusive disease.
- Pregnancy.
- Patients on palliative care.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Amiens hospital
Amiens, 80000
Pauline Caillard, MD, 03 22 45 58 66, caillard.pauline@chu-amiens.fr
About this study
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
- Being tested
- blood sample
- Keywords
- Acute Kidney Injury, Uremic; Toxemia, vascular dysfunction, cardiac dysfunction, cardiovascular prognosis
- Medical subject headings
- Acute Kidney Injury, Toxemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleOther
Blood sample withdrawal will be done and serum creatinine, IS, PCS, FGF-23, Angiopoietin-2, VCAM-1, E-Selectin and Troponin will be measured.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of pulse wave velocity (PWV) measurement from baseline
Measured: at 3 months
Secondary outcomes (8)
Correlation between Para-cresyl Sulfate (PCS) concentration and PWV
Measured: 3 months
Correlation between Fibroblast Growth Factor 23 (FGF23) concentration and PWV
Measured: 3 months
Correlation between Fibroblast Growth Factor 23 (FGF23) concentration and arterial pressure measurement
Measured: 3 months
Correlation between Fibroblast Growth Factor 23 (FGF23) concentration and cardiac diastolic function
Measured: 3 months
Correlation between IS concentration and arterial pressure measurement
Measured: 3 months
Correlation between IS concentration and cardiac diastolic function
Measured: 3 months
Correlation between Para-cresyl Sulfate (PCS) concentration and arterial pressure measurement
Measured: 3 months
Correlation between Para-cresyl Sulfate (PCS) concentration and cardiac diastolic function
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start13 Dec 2022
- Primary completionSep 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05659589
- Sponsor's protocol ID
- PI2021_843_0143
- Acronym
- VASC-AKI
- Status last verified
- May 2025
- First submitted
- 13 Dec 2022
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Role of the Uremic Toxin Indoxyl Sulfate on Vascular and Cardiac Functions During Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT05659589
- Acronym / sponsor ID
- VASC-AKI / PI2021_843_0143
- Conditions
- Acute Kidney Injury, Uremic; Toxemia, Vascular Dysfunction, Cardiac Dysfunction, Cardiovascular Prognosis
- Keywords
- Acute Kidney Injury, Uremic; Toxemia, vascular dysfunction, cardiac dysfunction, cardiovascular prognosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 13 Dec 2022 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 21 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sampleBlood sample withdrawal will be done and serum creatinine, IS, PCS, FGF-23, Angiopoietin-2, VCAM-1, E-Selectin and Troponin will be measured. | Other | – |
Primary outcome
Change of pulse wave velocity (PWV) measurement from baseline
Time frame: at 3 months
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sample in people with Acute Kidney Injury and Uremic; Toxemia, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pauline Caillard, MD (03 22 45 58 66, caillard.pauline@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of pulse wave velocity (PWV) measurement from baseline (time frame: at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.