Intra Individual Evaluation of Uremic Toxin Levels in Hemodialysed Patients

NCT ID: NCT02480699

Last Updated: 2023-05-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-20
• Study Completion Date: 2023-05-25

Brief Summary

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

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.

Conditions

Chronic Kidney Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Hemodialysed patients

Group Type: EXPERIMENTAL

Recurring blood sample

Intervention Type: BIOLOGICAL

dietary survey

Intervention Type: OTHER

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.

Interventions

Recurring blood sample

Intervention Type: BIOLOGICAL

dietary survey

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Urielle DESALBRES, Director

Role: STUDY_DIRECTOR

Assistance Publique Hôpitaux de Marseille

Locations

Assistance Publique H^^opitaux de Marseille

Marseille, , France

Countries

France

Other Identifiers

2015-A00319-40

Identifier Type: REGISTRY

Identifier Source: secondary_id

RCAPHM15_0083

Identifier Type: OTHER

Identifier Source: secondary_id

2015-10

Identifier Type: -

Identifier Source: org_study_id