Evaluation of a Multidisciplinary Care Pathway on the Evolution of Renal Function in Patients With Advanced Chronic Kidney Disease
- Conditions
- Chronic Kidney Disease Stage 5Chronic Kidney Disease stage4
- Registration Number
- NCT06495385
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 535
- 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
- Primary Outcome Measures
Name Time Method Evolution of estimated Glomerular filtration rate with the CKD-EPI formula adjusted for 1.73m2 of body surface area for the three groups Month : 6, 12, 18 and 24 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. The CKD-EPI formula used is as follows: The conversion of serum creatinine level for the CKD-EPI formula was done as follows: creatinine level (mg/dl) = creatinine level (μmol/l) × 0.01131222 (considering that 1 mg/dl creatinine = 88.4 μmol/l creatinine). A GFR of 60 or more is within the normal range. A GFR below 60 may indicate kidney disease.
- Secondary Outcome Measures
Name Time Method Evolution of dietary parameters : protein consumption Month : 6, 12, 18 and 24 24h protein consumption are measured in g/24h.
Evolution of patients' survival for every group during the study period Month : 6, 12, 18 and 24 Patients survival is measured as a percentage of remaining patients from baseline.
Evolution of preemptive transplantation during the study period for the three study groups Month : 6, 12, 18 and 24 The number of preventive transplants will be compared in each group.
Evolution of biological parameters : alkaline reserve levels Month : 6, 12, 18 and 24 Plasma alkaline reserve levels are measured in mmol/l.
Evolution of renal survival over the follow up period for every group Month : 6, 12, 18 and 24 Renal survival is measured as a percentage of remaining patients from baseline.
Evolution of biological parameters : plasma calcium Month : 6, 12, 18 and 24 Plasma Calcium levels are measured as mg/dL.
Evolution of biological parameters : phosphate Month : 6, 12, 18 and 24 Plasma Phosphate levels are measured as mg/dL.
Evolution of biological parameters : Haemoglobin Month : 6, 12, 18 and 24 Haemoglobin levels are measured as gram/dL.
Evolution of dietary parameters : salt consumption Month : 6, 12, 18 and 24 24h salt consumption are measured in g/24h.
Evolution of biological parameters : parathyroid hormone Month : 6, 12, 18 and 24 Plasma parathyroid hormone levels are measured in pg/ml.
Quality of life questionnaire EUROQOL 5 dimensions (EQ-5D-5L) Month : 6, 12, 18 and 24 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".
Trial Locations
- Locations (1)
AURA Santé
🇫🇷Chamalières, France
AURA Santé🇫🇷Chamalières, France