Evaluation of a Multidisciplinary Care Pathway on the Evolution of Renal Function in Patients With Advanced Chronic Kidney Disease
NCT ID: NCT06495385
Last Updated: 2024-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
535 participants
OBSERVATIONAL
2024-04-09
2024-09-30
Brief Summary
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In order to reduce the number of dialysis patients, the French state has induced a national program proposing a multidisciplinary care pathway including the nephrology visits and at least one consultation with a dietitian and a specialist renal nurse in all patients with Chronic Kidney Disease stage 4 and 5.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Study group
Full participation (medical + dietitian+ specialist nurse)
Evolution of renal function
Plasma creatinine levels and glomerular filtration rate estimated using the CKD-Epi formula adjusted for 1.73 m2 body surface area will be measured.
Measurement of haemoglobin levels
Haemoglobin levels will be measured.
Measurement of biological parameters
Plasma levels of urea, calcium, phosphorus and parathyroid hormone, as well as alkaline reserve, will be measured.
Measure sodium and protein consumption
24-hour urine volume, proteinuria, urea and sodium, will be measured.
Quality of life questionnaire EUROQOL 5 dimensions (EQ-5D-5L)
The descriptive system comprises five dimensions: mobility, personal care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, mild problems, moderate problems, severe problems and extreme problems. The figures for the five dimensions can be combined into a 5-digit number describing the patient's state of health. Scores close to 1 indicate "the best health you can imagine" and those close to 0 "the worst health you can imagine".
Control 1
Partial participation (medical+ dietitian OR specialist nurse)
Evolution of renal function
Plasma creatinine levels and glomerular filtration rate estimated using the CKD-Epi formula adjusted for 1.73 m2 body surface area will be measured.
Measurement of haemoglobin levels
Haemoglobin levels will be measured.
Measurement of biological parameters
Plasma levels of urea, calcium, phosphorus and parathyroid hormone, as well as alkaline reserve, will be measured.
Measure sodium and protein consumption
24-hour urine volume, proteinuria, urea and sodium, will be measured.
Quality of life questionnaire EUROQOL 5 dimensions (EQ-5D-5L)
The descriptive system comprises five dimensions: mobility, personal care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, mild problems, moderate problems, severe problems and extreme problems. The figures for the five dimensions can be combined into a 5-digit number describing the patient's state of health. Scores close to 1 indicate "the best health you can imagine" and those close to 0 "the worst health you can imagine".
Control 2
No participation (medical visit only)
Evolution of renal function
Plasma creatinine levels and glomerular filtration rate estimated using the CKD-Epi formula adjusted for 1.73 m2 body surface area will be measured.
Measurement of haemoglobin levels
Haemoglobin levels will be measured.
Measurement of biological parameters
Plasma levels of urea, calcium, phosphorus and parathyroid hormone, as well as alkaline reserve, will be measured.
Measure sodium and protein consumption
24-hour urine volume, proteinuria, urea and sodium, will be measured.
Quality of life questionnaire EUROQOL 5 dimensions (EQ-5D-5L)
The descriptive system comprises five dimensions: mobility, personal care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, mild problems, moderate problems, severe problems and extreme problems. The figures for the five dimensions can be combined into a 5-digit number describing the patient's state of health. Scores close to 1 indicate "the best health you can imagine" and those close to 0 "the worst health you can imagine".
Interventions
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Evolution of renal function
Plasma creatinine levels and glomerular filtration rate estimated using the CKD-Epi formula adjusted for 1.73 m2 body surface area will be measured.
Measurement of haemoglobin levels
Haemoglobin levels will be measured.
Measurement of biological parameters
Plasma levels of urea, calcium, phosphorus and parathyroid hormone, as well as alkaline reserve, will be measured.
Measure sodium and protein consumption
24-hour urine volume, proteinuria, urea and sodium, will be measured.
Quality of life questionnaire EUROQOL 5 dimensions (EQ-5D-5L)
The descriptive system comprises five dimensions: mobility, personal care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, mild problems, moderate problems, severe problems and extreme problems. The figures for the five dimensions can be combined into a 5-digit number describing the patient's state of health. Scores close to 1 indicate "the best health you can imagine" and those close to 0 "the worst health you can imagine".
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients with insufficient or no data during the 24 month of follow up period
* Active treatment with corticosteroids, cytotoxic or immunosuppressive drugs, ongoing infection, autoimmune disease or active tumor process.
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Saint Etienne
OTHER
Responsible Party
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Principal Investigators
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Hélène PAGES, nurse
Role: PRINCIPAL_INVESTIGATOR
CHU de Saint-Etienne
Locations
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AURA Santé
Chamalières, , France
Countries
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Other Identifiers
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IRBN1502023/CHUSTE
Identifier Type: -
Identifier Source: org_study_id
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