Overview

This trial is active, not recruiting.

Condition chronic kidney disease
Treatment dialysis, kidney transplant
Sponsor University of Sydney
Collaborator National Health and Medical Research Council, Australia
Start date October 2012
End date September 2015
Trial size 721 participants
Trial identifier NCT01768624, RM-1/12

Summary

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:

1. 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,

2. less than 15% of stage 5 chronic kidney disease patients who plan for conservative care commence dialysis within 3 years.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective retrospective
Arm
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
dialysis, kidney transplant

Primary Outcomes

Measure
The proportion of patients who make the transition to home dialysis, after an initial start on center-based hemodialysis.
time frame: 5 years

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Patient Information About Options for Treatment (PINOT) Follow up Study: Answering Important Questions in Home Dialysis and Conservative Care.
Principal investigator Rachael L Morton, PhD
Description 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).
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by University of Sydney.