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

Primary Purpose

Acute Kidney Injury, Uremic; Toxemia, Vascular Dysfunction

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood sample
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional screening trial for Acute Kidney Injury focused on measuring Acute Kidney Injury, Uremic; Toxemia, vascular dysfunction, cardiac dysfunction, cardiovascular prognosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Amiens hospitalRecruiting

Outcomes

Primary Outcome Measures

Change of pulse wave velocity (PWV) measurement from baseline

Secondary Outcome Measures

Correlation between Para-cresyl Sulfate (PCS) concentration and PWV
Correlation between Fibroblast Growth Factor 23 (FGF23) concentration and PWV
Correlation between Fibroblast Growth Factor 23 (FGF23) concentration and arterial pressure measurement
Correlation between Fibroblast Growth Factor 23 (FGF23) concentration and cardiac diastolic function
Correlation between IS concentration and arterial pressure measurement
Correlation between IS concentration and cardiac diastolic function
Correlation between Para-cresyl Sulfate (PCS) concentration and arterial pressure measurement
Correlation between Para-cresyl Sulfate (PCS) concentration and cardiac diastolic function

Full Information

First Posted
December 13, 2022
Last Updated
December 13, 2022
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT05659589
Brief Title
Prognostic Role of the Uremic Toxin Indoxyl Sulfate on Vascular and Cardiac Functions During Acute Kidney Injury
Acronym
VASC-AKI
Official Title
Prognostic Role of the Uremic Toxin Indoxyl Sulfate on Vascular and Cardiac Functions During Acute Kidney Injury
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 13, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury, Uremic; Toxemia, Vascular Dysfunction, Cardiac Dysfunction, Cardiovascular Prognosis
Keywords
Acute Kidney Injury, Uremic; Toxemia, vascular dysfunction, cardiac dysfunction, cardiovascular prognosis

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
blood sample
Intervention Description
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 Measure Information:
Title
Change of pulse wave velocity (PWV) measurement from baseline
Time Frame
at 3 months
Secondary Outcome Measure Information:
Title
Correlation between Para-cresyl Sulfate (PCS) concentration and PWV
Time Frame
3 months
Title
Correlation between Fibroblast Growth Factor 23 (FGF23) concentration and PWV
Time Frame
3 months
Title
Correlation between Fibroblast Growth Factor 23 (FGF23) concentration and arterial pressure measurement
Time Frame
3 months
Title
Correlation between Fibroblast Growth Factor 23 (FGF23) concentration and cardiac diastolic function
Time Frame
3 months
Title
Correlation between IS concentration and arterial pressure measurement
Time Frame
3 months
Title
Correlation between IS concentration and cardiac diastolic function
Time Frame
3 months
Title
Correlation between Para-cresyl Sulfate (PCS) concentration and arterial pressure measurement
Time Frame
3 months
Title
Correlation between Para-cresyl Sulfate (PCS) concentration and cardiac diastolic function
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pauline Caillard, MD
Phone
03 22 45 58 66
Email
caillard.pauline@chu-amiens.fr
Facility Information:
Facility Name
Amiens hospital
City
Amiens
ZIP/Postal Code
80000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pauline Caillard, MD
Phone
03 22 45 58 66
Email
caillard.pauline@chu-amiens.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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