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

NCT06495385 | Active Not Recruiting

• 1 other identifier: IRBN1502023/CHUSTE
• Study Type: observational
• Target: 535
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease stage4; Chronic Kidney Disease Stage 5

Keywords

Multidisciplinary Care; Pathway; Chronic Kidney disease; Patients' education

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Evolution of renal survival over the follow up period for every group

  Month : 6, 12, 18 and 24

• Evolution of patients' survival for every group during the study period

  Month : 6, 12, 18 and 24

• Evolution of preemptive transplantation during the study period for the three study groups

  Month : 6, 12, 18 and 24

• Evolution of biological parameters : Haemoglobin

  Month : 6, 12, 18 and 24

• Evolution of biological parameters : plasma calcium

  Month : 6, 12, 18 and 24

Study Arms (3)

Study group

Full participation (medical + dietitian+ specialist nurse)

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)

Control 1

Partial participation (medical+ dietitian OR specialist nurse)

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)

Control 2

No participation (medical visit only)

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)

Interventions

Evolution of renal function DIAGNOSTIC_TEST

Plasma creatinine levels and glomerular filtration rate estimated using the CKD-Epi formula adjusted for 1.73 m2 body surface area will be measured.

Control 1; Control 2; Study group

Measurement of haemoglobin levels DIAGNOSTIC_TEST

Haemoglobin levels will be measured.

Control 1; Control 2; Study group

Measurement of biological parameters DIAGNOSTIC_TEST

Plasma levels of urea, calcium, phosphorus and parathyroid hormone, as well as alkaline reserve, will be measured.

Control 1; Control 2; Study group

Measure sodium and protein consumption DIAGNOSTIC_TEST

24-hour urine volume, proteinuria, urea and sodium, will be measured.

Control 1; Control 2; Study group

Quality of life questionnaire EUROQOL 5 dimensions (EQ-5D-5L) BEHAVIORAL

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; Control 2; Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with advanced chronic kidney disease will be included.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

AURA Santé

Chamalières, France

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hélène PAGES, nurse

  CHU de Saint-Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: July 10, 2024
• Study Start: April 9, 2024
• Primary Completion: May 22, 2024
• Study Completion: September 1, 2024
• Last Updated: July 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)