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Active, Not Recruiting

NCT Number: NCT06495385

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Chronic Kidney Disease stage4 Chronic Disease Chronic Kidney Disease Stage 5 Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AURA Santé

Chamalières, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Measurement of haemoglobin levels

Diagnostic Test

Haemoglobin levels will be measured.

Measurement of biological parameters

Diagnostic Test

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

Measure sodium and protein consumption

Diagnostic Test

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

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".

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

    Time frame: 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 outcomes

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

    Time frame: Month : 6, 12, 18 and 24

    Renal survival is measured as a percentage of remaining patients from baseline.

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

    Time frame: Month : 6, 12, 18 and 24

    Patients survival is measured as a percentage of remaining patients from baseline.

  3. Evolution of preemptive transplantation during the study period for the three study groups

    Time frame: Month : 6, 12, 18 and 24

    The number of preventive transplants will be compared in each group.

  4. Evolution of biological parameters : Haemoglobin

    Time frame: Month : 6, 12, 18 and 24

    Haemoglobin levels are measured as gram/dL.

  5. Evolution of biological parameters : plasma calcium

    Time frame: Month : 6, 12, 18 and 24

    Plasma Calcium levels are measured as mg/dL.

  6. Evolution of biological parameters : phosphate

    Time frame: Month : 6, 12, 18 and 24

    Plasma Phosphate levels are measured as mg/dL.

  7. Evolution of biological parameters : parathyroid hormone

    Time frame: Month : 6, 12, 18 and 24

    Plasma parathyroid hormone levels are measured in pg/ml.

  8. Evolution of biological parameters : alkaline reserve levels

    Time frame: Month : 6, 12, 18 and 24

    Plasma alkaline reserve levels are measured in mmol/l.

  9. Evolution of dietary parameters : salt consumption

    Time frame: Month : 6, 12, 18 and 24

    24h salt consumption are measured in g/24h.

  10. Evolution of dietary parameters : protein consumption

    Time frame: Month : 6, 12, 18 and 24

    24h protein consumption are measured in g/24h.

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

    Time frame: 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".

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 10, 2024
Registry last updated
Jul 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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