PINOT Follow-up Study in End-stage Kidney Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by University of Sydney.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
National Health and Medical Research Council, Australia
Sydney South West Area Health Service
South West Sydney Local Health District
Kidney Health Australia
Information provided by (Responsible Party):
University of Sydney
ClinicalTrials.gov Identifier:
NCT01768624
First received: January 11, 2013
Last updated: January 14, 2013
Last verified: March 2012
  Purpose

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.

Condition Intervention
Chronic Kidney Disease
Procedure: dialysis, kidney transplant

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Patient Information About Options for Treatment (PINOT) Follow up Study: Answering Important Questions in Home Dialysis and Conservative Care.

Resource links provided by NLM:


Further study details as provided by University of Sydney:

Primary Outcome Measures:
  • The proportion of patients who make the transition to home dialysis, after an initial start on center-based hemodialysis. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 721
Study Start Date: October 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

Detailed 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).

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adults and children with chronic kidney disease attending renal treatment centres in Australian public hospitals and private practices

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01768624

Locations
Australia, New South Wales
University of Sydney
Sydney, New South Wales, Australia, 2006
Sponsors and Collaborators
University of Sydney
National Health and Medical Research Council, Australia
Sydney South West Area Health Service
South West Sydney Local Health District
Kidney Health Australia
Investigators
Principal Investigator: Rachael L Morton, PhD University of Sydney
  More Information

Additional Information:
Publications:
Responsible Party: University of Sydney
ClinicalTrials.gov Identifier: NCT01768624     History of Changes
Other Study ID Numbers: RM-1/12
Study First Received: January 11, 2013
Last Updated: January 14, 2013
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by University of Sydney:
chronic kidney disease
dialysis
pre dialysis education
transplantation
conservative care

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on April 14, 2014