Evaluation of a Multidisciplinary Care Pathway on the Evolution of Renal Function in Patients With Advanced Chronic Kidney Disease
NCT Number: NCT06495385
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Chronic Kidney Disease stage4|Chronic Kidney Disease Stage 5
Interventions: DIAGNOSTIC_TEST: Evolution of renal function|DIAGNOSTIC_TEST: Measurement of haemoglobin levels|DIAGNOSTIC_TEST: Measurement of biological parameters|DIAGNOSTIC_TEST: Measure sodium and protein consumption|BEHAVIORAL: Quality of life questionnaire EUROQOL 5 dimensions (EQ-5D-5L)
Sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 535
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-09
Completion Date: 2024-09
Locations: AURA Santé, Chamalières, France

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.

Primary Outcome Measures: Evolution of estimated Glomerular filtration rate with the CKD-EPI formula adjusted for 1.73m2 of body surface area for the three groups, 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., Month : 6, 12, 18 and 24
Secondary Outcome Measures: Evolution of renal survival over the follow up period for every group, Renal survival is measured as a percentage of remaining patients from baseline., Month : 6, 12, 18 and 24|Evolution of patients' survival for every group during the study period, Patients survival is measured as a percentage of remaining patients from baseline., Month : 6, 12, 18 and 24|Evolution of preemptive transplantation during the study period for the three study groups, The number of preventive transplants will be compared in each group., Month : 6, 12, 18 and 24|Evolution of biological parameters : Haemoglobin, Haemoglobin levels are measured as gram/dL., Month : 6, 12, 18 and 24|Evolution of biological parameters : plasma calcium, Plasma Calcium levels are measured as mg/dL., Month : 6, 12, 18 and 24|Evolution of biological parameters : phosphate, Plasma Phosphate levels are measured as mg/dL., Month : 6, 12, 18 and 24|Evolution of biological parameters : parathyroid hormone, Plasma parathyroid hormone levels are measured in pg/ml., Month : 6, 12, 18 and 24|Evolution of biological parameters : alkaline reserve levels, Plasma alkaline reserve levels are measured in mmol/l., Month : 6, 12, 18 and 24|Evolution of dietary parameters : salt consumption, 24h salt consumption are measured in g/24h., Month : 6, 12, 18 and 24|Evolution of dietary parameters : protein consumption, 24h protein consumption are measured in g/24h., Month : 6, 12, 18 and 24|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"., Month : 6, 12, 18 and 24