PINOT Follow-up Study in End-stage Kidney Disease
|ClinicalTrials.gov Identifier: NCT01768624|
Recruitment Status : Completed
First Posted : January 15, 2013
Last Update Posted : October 26, 2016
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.
|Condition or disease||Intervention/treatment|
|Chronic Kidney Disease||Procedure: dialysis, kidney transplant|
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).
|Study Type :||Observational|
|Actual Enrollment :||721 participants|
|Official Title:||Patient Information About Options for Treatment (PINOT) Follow up Study: Answering Important Questions in Home Dialysis and Conservative Care.|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2016|
Stage 5 chronic kidney disease
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|
- The proportion of patients who make the transition to home dialysis, after an initial start on center-based hemodialysis. [ Time Frame: 5 years ]
- 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. [ Time Frame: 5 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01768624
|Australia, New South Wales|
|University of Sydney|
|Sydney, New South Wales, Australia, 2006|
|University of Oxford|
|Headington, Oxfordshire, United Kingdom, OX38QY|
|Principal Investigator:||Rachael L Morton, PhD||University of Sydney|