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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Kidney Disease Stage 5; Chronic Kidney Disease stage4
• Intervention / Treatment: 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)

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 Type: Observational
• Enrollment (Estimated): 535

Contacts and Locations

Study Locations

• France
  • Chamalières, France
    • AURA Santé

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with advanced chronic kidney disease will be included.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study group; Full participation (medical + dietitian+ specialist nurse)	Diagnostic test: Evolution of renal function; Plasma creatinine levels and glomerular filtration rate estimated using the CKD-Epi formula adjusted for 1.73 m2 body surface area will be measured.; Diagnostic test: Measurement of haemoglobin levels; Haemoglobin levels will be measured.; Diagnostic test: Measurement of biological parameters; Plasma levels of urea, calcium, phosphorus and parathyroid hormone, as well as alkaline reserve, will be measured.; Diagnostic test: Measure sodium and protein consumption; 24-hour urine volume, proteinuria, urea and sodium, will be measured.; Behavioral: 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".
Control 1; Partial participation (medical+ dietitian OR specialist nurse)	Diagnostic test: Evolution of renal function; Plasma creatinine levels and glomerular filtration rate estimated using the CKD-Epi formula adjusted for 1.73 m2 body surface area will be measured.; Diagnostic test: Measurement of haemoglobin levels; Haemoglobin levels will be measured.; Diagnostic test: Measurement of biological parameters; Plasma levels of urea, calcium, phosphorus and parathyroid hormone, as well as alkaline reserve, will be measured.; Diagnostic test: Measure sodium and protein consumption; 24-hour urine volume, proteinuria, urea and sodium, will be measured.; Behavioral: 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".
Control 2; No participation (medical visit only)	Diagnostic test: Evolution of renal function; Plasma creatinine levels and glomerular filtration rate estimated using the CKD-Epi formula adjusted for 1.73 m2 body surface area will be measured.; Diagnostic test: Measurement of haemoglobin levels; Haemoglobin levels will be measured.; Diagnostic test: Measurement of biological parameters; Plasma levels of urea, calcium, phosphorus and parathyroid hormone, as well as alkaline reserve, will be measured.; Diagnostic test: Measure sodium and protein consumption; 24-hour urine volume, proteinuria, urea and sodium, will be measured.; Behavioral: 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".

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Hélène PAGES, nurse, CHU de Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2024
• Primary Completion (Actual): May 22, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: January 26, 2024
• First Submitted That Met QC Criteria: July 9, 2024
• First Posted (Actual): July 10, 2024

Study Record Updates

• Last Update Posted (Actual): July 10, 2024
• Last Update Submitted That Met QC Criteria: July 9, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Chronic Kidney disease; Pathway; Multidisciplinary Care; Patients' education
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Chrysarobin
• Other Study ID Numbers: IRBN1502023/CHUSTE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No