PINOT Follow-up Study in End-stage Kidney Disease

NCT ID: NCT01768624

Last Updated: 2016-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

721 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2016-09-30

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:

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.

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).

Conditions

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Chronic Kidney Disease

Keywords

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chronic kidney disease dialysis pre dialysis education transplantation conservative care

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

dialysis, kidney transplant

Intervention Type PROCEDURE

Interventions

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dialysis, kidney transplant

Intervention Type PROCEDURE

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Health and Medical Research Council, Australia

OTHER

Sponsor Role collaborator

Sydney South West Area Health Service

OTHER_GOV

Sponsor Role collaborator

South West Sydney Local Health District

OTHER

Sponsor Role collaborator

Kidney Health Australia

UNKNOWN

Sponsor Role collaborator

University of Sydney

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rachael L Morton, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sydney

Locations

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University of Sydney

Sydney, New South Wales, Australia

Site Status

University of Oxford

Headington, Oxfordshire, United Kingdom

Site Status

Countries

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Australia United Kingdom

References

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Morton RL, Howard K, Webster AC, Snelling P. Patient INformation about Options for Treatment (PINOT): a prospective national study of information given to incident CKD Stage 5 patients. Nephrol Dial Transplant. 2011 Apr;26(4):1266-74. doi: 10.1093/ndt/gfq555. Epub 2010 Sep 6.

Reference Type BACKGROUND
PMID: 20819955 (View on PubMed)

Morton RL, Turner RM, Howard K, Snelling P, Webster AC. Patients who plan for conservative care rather than dialysis: a national observational study in Australia. Am J Kidney Dis. 2012 Mar;59(3):419-27. doi: 10.1053/j.ajkd.2011.08.024. Epub 2011 Oct 20.

Reference Type BACKGROUND
PMID: 22014401 (View on PubMed)

Morton RL, Webster AC, McGeechan K, Howard K, Murtagh FEM, Gray NA, Kerr PG, Germain MJ, Snelling P. Conservative Management and End-of-Life Care in an Australian Cohort with ESRD. Clin J Am Soc Nephrol. 2016 Dec 7;11(12):2195-2203. doi: 10.2215/CJN.11861115. Epub 2016 Oct 3.

Reference Type RESULT
PMID: 27697783 (View on PubMed)

Other Identifiers

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RM-1/12

Identifier Type: -

Identifier Source: org_study_id