PINOT Follow-up Study in End-stage Kidney Disease

Study Overview
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Brief Summary
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The primary aims of the Patient INformation about Options for Treatment (PINOT) Follow-up Study are to determine the proportions of patients, identified in the 2009 PINOT cohort that: (i)Made the transition to home dialysis, after an initial start on center-based dialysis. (ii)Commenced dialysis, or a time-limited trial of dialysis within 3 years, after confirmed plans for conservative care. The hypotheses to be tested in the PINOT follow-up study are: 50% of stage 5 chronic kidney disease patients who plan for home dialysis do not commence home dialysis within 3 years, and instead remain on centre-based haemodialysis; and, less than 15% of stage 5 chronic kidney disease patients who plan for conservative care commence dialysis within 3 years.

Detailed Description
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The secondary aims of the follow-up study include: (i) To assess the primary reasons patients did not transition to home dialysis, in the planned home dialysis group. (ii)To compare 3 and 5 year survival rates among patients who commenced conservative care and patients who commenced renal replacement therapy. (iii) To assess the types of dialysis utilisation over a 5 year time period among the total cohort of patients. (iv)To determine how renal palliative care services were engaged for conservative care patients, and document the patient's place of death (i.e. hospital, hospice, home with community palliative care).

Official Title
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Patient Information About Options for Treatment (PINOT) Follow up Study: Answering Important Questions in Home Dialysis and Conservative Care.

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Procedure: dialysis, kidney transplant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults and children with end stage kidney disease (eGFR <15 ml/min) who commenced renal replacement therapy or conservative care in Australia between July and September 2009 Exclusion Criteria: Patients returning to dialysis after a failed transplant, Patients with acute renal failure
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stage 5 chronic kidney disease<br>Patients receiving home hemodialysis Patients receiving home peritoneal dialysis Patients receiving center-based hemodialysis Patients who had a pre-emptive kidney transplant Patients who planned for renal conservative care | Procedure: dialysis, kidney transplant<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients who make the transition to home dialysis, after an initial start on center-based hemodialysis. |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients who commence dialysis, or have a time-limited trial of dialysis within 3 and 5 years, after a confirmed plan for conservative care. |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dialysis, pre dialysis education, transplantation, conservative care, chronic kidney disease