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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-A00464-47 | Other Identifier | RCB |
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The main objective of this study is to show that the systematic use of a prognostic score as early as possible after the initiation of dialysis in patients over 70 years of age and with a good prognosis at 3 years of dialysis results in an increase in the number of entries on a kidney transplant waiting list at 12 months after the initiation of dialysis.
This prospective assessment is carried out as part of a historico-prospective before-after study in parallel with a survey of changes in national practices over the same time period via a here-elsewhere type study.
Historical data (i.e the. "before" period) will include incident dialysis cases during the calendar years 2013, 2014 and 2015 before the start of the prospective phase (i.e. "after" period, which is represented by the current declaration); since a preliminary study demonstrated that the data are comparable from 2011 to 2013, we will use the average of data thus obtained. Historical data will be retrieved from the REIN (The French Renal Epidemiology and Information Network) registry data and will be validated by investigators at each center.
The secondary objectives are:
A. To show that the systematic use of the score at the initiation of dialysis can shorten the registration delay on a kidney transplant waiting list; to evaluate the time between initiation of dialysis and registration on a national waiting list for kidney transplants, while assessing the duration of the pre-transplant assessment.
B. To identify barriers to registration on the kidney transplant waiting list as well as the related time delay in this population (medical and non-medical factors), the rates and causes of patient refusal for registration and the possible evolution this refusal over time.
C. To evaluate the economic impact of the introduction of the renal transplant clinical prognostic score.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic dialysis patients | Experimental | The study population consists of patients over 70 (≥) and under 85 years (<) of age with stage 5 chronic renal disease and initiating a first session of chronic dialysis in the Languedoc-Roussillon and Midi-Pyrénées regions. Eligible patients must have a 3 year prognostic mortality score less than (<) 7 points (Dusseux et al. 2015). Intervention: Systematic use of a prognostic score |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Systematic use of a prognostic score | Other | The prognostic score is given in Dusseux et al 2015. It will be used as soon as possible after the initiation of dialysis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The % number of registrants on the kidney transplant waiting list | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Delay between the initiation of dialysis and inclusion on the kidney transplant waiting list | This outcome integrates the the duration of initial assessment and is measured by the difference between the start and end dates of the pre-transplant assessment. | 12 months |
| The number of refusals by patients for registration on the kidney transplant waiting list |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olivier Moranne, MD, PhD | Centre Hospitalier Universitaire de Nīmes | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Claude Bernard | Albi | 81000 | France | |||
| AIDER - Unité de Dialyse d'Alès |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25671769 | Background | Dusseux E, Albano L, Fafin C, Hourmant M, Guerin O, Couchoud C, Moranne O. A simple clinical tool to inform the decision-making process to refer elderly incident dialysis patients for kidney transplant evaluation. Kidney Int. 2015 Jul;88(1):121-9. doi: 10.1038/ki.2015.25. Epub 2015 Feb 11. |
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| 12 months |
| In case of patient refusal for registration, the reasons why (qualitative approach) | 12 months |
| The number of cases where there is a medical contra-indication for registration on the kidney transplant waiting list | 12 months |
| In case of a medical contra-indication for registration on the kidney transplant waiting list, the cause (qualitative approach) | 12 months |
| The cost of care associated with dialysis patients and dialysed-and-then-transplanted patients will be estimated from the point of view of the French health insurance system | 12 months |
| Alès |
| 30100 |
| France |
| CH d'Auch | Auch | 32008 | France |
| Centre d'Hemodialyse Languedoc Méditérranéen | Béziers | 34500 | France |
| Medipole Grand Sud St Roch | Cabestany | 66330 | France |
| CH de Cahors | Cahors | France |
| NephroCare | Castelnau-le-Lez | 34170 | France |
| CH de Carcassonne | Cité de Carcassonne | 11000 | France |
| AAIR Midi-Pyrénées | Colomiers | France |
| Centre Hospitalier Intercommunal du Val d'Ariège | Foix | 09017 | France |
| Clinique du Pont de Chaume | Montauban | 82017 | France |
| AIDER de Montpellier | Montpellier | 34295 | France |
| CHRU de Montpellier - Hôpital Lapeyronie | Montpellier | 34295 | France |
| Clinique de l'Occitanie | Muret | 31603 | France |
| Polyclinique Le Languedoc | Narbonne | 11000 | France |
| AIDER - Unité de Dialyse de Nîmes | Nîmes | 30029 | France |
| CHRU de Nîmes - Hôpital Universitaire Carémeau | Nîmes | 30029 | France |
| Gardialyse | Nîmes | 30900 | France |
| CH de Perpignan - Hôpital Saint Jean | Perpignan | 66046 | France |
| Centre Hospitalier Jacques Puel | Rodez | 12000 | France |
| CH de Bigorre | Tarbes | 65013 | France |
| CHRU de Toulouse - Hôpital de Rangueil | Toulouse | 31059 | France |
| CHRU de Toulouse - Hôpital Larrey | Toulouse | 31059 | France |
| CHRU de Toulouse - Hôptal Casselardit | Toulouse | 31059 | France |
| Clinique Néphrologique Saint-Exupéry | Toulouse | 31077 | France |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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