Evaluation of a Multidisciplinary Care Pathway on the Evolution of Renal Function in Patients With Advanced Chronic Kidney Disease

Active, not recruiting

• Conditions: Chronic Kidney Disease Stage 5; Chronic Kidney Disease stage4
• 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)

• Registration Number: NCT06495385
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Study Timeline

• Study First Submitted: 2024-01-26
• Study Start: 2024-04-09
• Primary Completion: 2024-05-22
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-09
• Last Update Submitted: 2024-07-09
• Study First Posted: 2024-07-10
• Last Update Posted: 2024-07-10
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 535

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study group	Measurement of haemoglobin levels	Full participation (medical + dietitian+ specialist nurse)
Study group	Measure sodium and protein consumption	Full participation (medical + dietitian+ specialist nurse)
Control 1	Measurement of haemoglobin levels	Partial participation (medical+ dietitian OR specialist nurse)
Study group	Evolution of renal function	Full participation (medical + dietitian+ specialist nurse)
Study group	Measurement of biological parameters	Full participation (medical + dietitian+ specialist nurse)
Control 1	Measure sodium and protein consumption	Partial participation (medical+ dietitian OR specialist nurse)
Control 2	Measure sodium and protein consumption	No participation (medical visit only)
Control 2	Quality of life questionnaire EUROQOL 5 dimensions (EQ-5D-5L)	No participation (medical visit only)
Control 1	Measurement of biological parameters	Partial participation (medical+ dietitian OR specialist nurse)
Control 2	Measurement of biological parameters	No participation (medical visit only)
Study group	Quality of life questionnaire EUROQOL 5 dimensions (EQ-5D-5L)	Full participation (medical + dietitian+ specialist nurse)
Control 1	Evolution of renal function	Partial participation (medical+ dietitian OR specialist nurse)
Control 2	Evolution of renal function	No participation (medical visit only)
Control 2	Measurement of haemoglobin levels	No participation (medical visit only)
Control 1	Quality of life questionnaire EUROQOL 5 dimensions (EQ-5D-5L)	Partial participation (medical+ dietitian OR specialist nurse)

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