Clinical trial NCT06495385: Evaluation of a Multidisciplinary Care Pathway on the Evolution of Renal Function in Patients With Advanced Chronic Kidney Disease
Official title: Evaluation of a Multidisciplinary Care Pathway on the Evolution of Renal Function in Patients With Advanced Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Kidney Disease stage4
Chronic Kidney Disease Stage 5
Keywords: Multidisciplinary Care
Pathway
Chronic Kidney disease
Patients' education
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2024-07-10
Enrollment: 535
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced chronic kidney disease will be included.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Evolution of estimated Glomerular filtration rate with the CKD-EPI formula adjusted for 1.73m2 of body surface area for the three groups
timeFrame: Month : 6, 12, 18 and 24
Secondary outcomes:
measure: Evolution of renal survival over the follow up period for every group
timeFrame: Month : 6, 12, 18 and 24
measure: Evolution of patients' survival for every group during the study period
timeFrame: Month : 6, 12, 18 and 24
measure: Evolution of preemptive transplantation during the study period for the three study groups
timeFrame: Month : 6, 12, 18 and 24
measure: Evolution of biological parameters : Haemoglobin
timeFrame: Month : 6, 12, 18 and 24
measure: Evolution of biological parameters : plasma calcium
timeFrame: Month : 6, 12, 18 and 24
measure: Evolution of biological parameters : phosphate
timeFrame: Month : 6, 12, 18 and 24
measure: Evolution of biological parameters : parathyroid hormone
timeFrame: Month : 6, 12, 18 and 24
measure: Evolution of biological parameters : alkaline reserve levels
timeFrame: Month : 6, 12, 18 and 24
measure: Evolution of dietary parameters : salt consumption
timeFrame: Month : 6, 12, 18 and 24
measure: Evolution of dietary parameters : protein consumption
timeFrame: Month : 6, 12, 18 and 24
measure: Quality of life questionnaire EUROQOL 5 dimensions (EQ-5D-5L)
timeFrame: Month : 6, 12, 18 and 24
Other outcomes:
Locations:
city: Chamalières
country: France
facility: AURA Santé
Study officials:
affiliation: CHU de Saint-Etienne
name: Hélène PAGES, nurse
role: PRINCIPAL_INVESTIGATOR
References: