Evaluation of a Pathway on the Evolution of Renal Function in Patients With Advanced Chronic Kidney Disease
- Conditions
- Kidney Function Issue
- Interventions
- Diagnostic Test: GFR
- Registration Number
- NCT06219798
- Lead Sponsor
- Association d' Utilisation du Rein Artificiel SANTE
- Brief Summary
The number of incident and prevalent patients with end stage renal disease on dialysis treatment is increasing in France and worldwide. A quarter of dialysis patients are initiating dialysis urgently through central venous catheters and the number of patients registered in the waiting list for renal transplantation before dialysis initiation is very low. This is also reflected in the very low number of pre-emptive renal transplantations.
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.
The aim of this single-center retrospective study is to evaluate the influence of the complete, partial or no participation in this program on the evolution of renal function and clinicobiological parameters in this group of patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- All stage 4 and 5 Chronic Kidney Disease patients that were included in the program from 01/01/2021 to 31/12/2021 in the clinics of AURA SANTE
- Patients without a medical follow up during this year (2021)
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Name of Arm 1: Study group GFR Description: Full participation (medical + dietitian+ specialist nurse) Name of Arm 2: Control 1 GFR Description: Partial participation (medical+ dietitian OR specialist nurse) Name of Arm 3: Control 2 GFR Description: No participation (medical visit only)
- Primary Outcome Measures
Name Time Method Glomerular filtration rate Every 6 months for 24 months The estimated Glomerular filtration rate is estimated with the CKD-EPI formula adjusted for 1.73m2 of body surface area and produced in ml/min/1.73m2 of body surface area
- Secondary Outcome Measures
Name Time Method Plasma Calcium levels Every 6 months for 24 months Evolution of plasma calcium levels during the study period in mg/dL
Patients survival rate Every 6 months for 24 months Number of deaths during the sudy period
Renal survival rate Every 6 months for 24 months Number of patients initiating dialysis during the study period
Haemoglobin levels Every 6 months for 24 months Evolution of haemoglobin levels during the study period in gram/dL
Plasma alcaline reserve levels Every 6 months for 24 months Evolution of plasma alcaline reserve levels during the study period in mmol/l
24h salt consumption Every 6 months for 24 months Evolution of salt consumption during the study period in g/24h
Plasma Phosphate levels Every 6 months for 24 months Evolution of plasma phosphate levels during the study period in mg/dL
Plasma parathyroid hormone levels Every 6 months for 24 months Evolution of plasma parathyroid hormone levels during the study period in pg/ml
24h protein consumption Every 6 months for 24 months Evolution of protein consumption during the study period in g/24h
Quality of life score through study completion, an average of 6 months Scores from Evaluation Quality of life,5 dimensions, 5 levels (EQ-5D-5L), the higher the score the better the outcome
Trial Locations
- Locations (1)
Aura Sante
🇫🇷Chamalières, Auvergne, France