Intra Individual Evaluation of Uremic Toxin Levels in Hemodialysed Patients

Study Overview
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Brief Summary
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Chronic kidney disease (CKD) is characterized by a irreversible decrease of kidney functions. It is characterized by accumulation of solutes called uremic toxins. Uremic toxins levels are implicated in cardiovascular complications associated with CKD. Several protein-bound toxins have been implicated in the increased cardiovascular risk such as indoxyl sulfate (IS), p cresol sulfate (pCS) and more recently the indole acetic acid (IAA). All clinical studies are performed with a single measurement at baseline assuming that the toxin levels are stable over time. The variability of uremic toxins level is not known. Furthermore, little is known concerning determinants of serum toxins level.

Detailed Description
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Colonic absorption play a major role in IS (indoxyl sulfate) and pCS level. IS and pCS level are significantly reduced in patient with colectomy. To validate the measurement of uremic toxins level in serum as biomarkers for cardiovascular risk, we need to know about intra-individual variability over time and the impact of diet or digestive disorders on uremic toxin serum level. We propose a prospective study evaluating the intra-individual variability in 3 uremic toxins serum levels the SI, the pCS and IAA. The main objective is to study the kinetics of three serum uremic toxins: the indoxyl sulfate, p cresyl sulfate and indole acetic acid (and thus determine the intra-individual variability) in a population of chronic hemodialysis patients during 1 year.

Official Title
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Intra Individual Evaluation of Uremic Toxin Levels in Hemodialysed Patients

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Biological: Recurring blood sample
* Other: dietary survey


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Major subjects of both sexes aged 18 and over Topics affiliates or beneficiaries of a social security scheme Haemodialysis patients whatever the etiology of renal failure for more than 3 months Patients not under antibiotic Agreeing to participate in the study and who signed a consent Patient able to understand a written questionnaire Exclusion Criteria: Pregnant or lactating women Detainees Adults under legal protection or unable to consent Patient's refusal to sign the informed consent for participation Possibility of recovery of renal function (eg scleroderma) Patients carrying a replicating viral infection (HCV, HIV). Taking antibiotics in the previous month by 1 sampling

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hemodialysed patients<br> | Biological: Recurring blood sample<br> <br> Other: dietary survey<br>* A dietary survey will be performed in all patients and every 3 months (4 surveys about 1 year). This survey will be given to the patient filled for 7 consecutive days. He must record during these 7 days, all of his food intake in quality and quantity. During a dialysis session this questionnaire will be taken with the patient by a dietician to better define the food intake. This surveys requires good patient compliance as well as his involvement that his collection is well within its food intake.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite measure of uremic toxins serum levels the SI, the pCS and IAA. | blood collection | 15 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dietary survey |  | 15 months |