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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06495385
Enrollment
535
Registered
2024-07-10
Start date
2024-04-09
Completion date
2024-09-30
Last updated
2024-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease stage4, Chronic Kidney Disease Stage 5

Keywords

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

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.

Interventions

DIAGNOSTIC_TESTEvolution 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_TESTMeasurement of haemoglobin levels

Haemoglobin levels will be measured.

DIAGNOSTIC_TESTMeasurement of biological parameters

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

DIAGNOSTIC_TESTMeasure sodium and protein consumption

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

BEHAVIORALQuality 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.

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Evolution of estimated Glomerular filtration rate with the CKD-EPI formula adjusted for 1.73m2 of body surface area for the three groupsMonth : 6, 12, 18 and 24The 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

MeasureTime frameDescription
Evolution of patients' survival for every group during the study periodMonth : 6, 12, 18 and 24Patients survival is measured as a percentage of remaining patients from baseline.
Evolution of preemptive transplantation during the study period for the three study groupsMonth : 6, 12, 18 and 24The number of preventive transplants will be compared in each group.
Evolution of biological parameters : HaemoglobinMonth : 6, 12, 18 and 24Haemoglobin levels are measured as gram/dL.
Evolution of biological parameters : plasma calciumMonth : 6, 12, 18 and 24Plasma Calcium levels are measured as mg/dL.
Evolution of biological parameters : phosphateMonth : 6, 12, 18 and 24Plasma Phosphate levels are measured as mg/dL.
Evolution of renal survival over the follow up period for every groupMonth : 6, 12, 18 and 24Renal survival is measured as a percentage of remaining patients from baseline.
Evolution of biological parameters : alkaline reserve levelsMonth : 6, 12, 18 and 24Plasma alkaline reserve levels are measured in mmol/l.
Evolution of dietary parameters : salt consumptionMonth : 6, 12, 18 and 2424h salt consumption are measured in g/24h.
Evolution of dietary parameters : protein consumptionMonth : 6, 12, 18 and 2424h protein consumption are measured in g/24h.
Quality of life questionnaire EUROQOL 5 dimensions (EQ-5D-5L)Month : 6, 12, 18 and 24The 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.
Evolution of biological parameters : parathyroid hormoneMonth : 6, 12, 18 and 24Plasma parathyroid hormone levels are measured in pg/ml.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026