Evaluation of the Integrated Home Dialysis Model

NCT02278159 | Completed

• 1 other identifier: ANZ41367
• Study Type: observational
• Target: 11,600
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate which home dialysis modality pattern (home hemodialysis \[HHD\], peritoneal dialysis \[PD\] or a combination of both, e.g. PD and then HHD) allows for the longest home dialysis survival, as defined by the time dialysed in a home environment. The investigators hypothesize that patients transferred from one home modality to another will have a longer home dialysis survival compared to patients treated only with PD or HHD.

Conditions

Kidney Failure, Chronic

Keywords

end-stage kidney disease; peritoneal dialysis; home hemodialysis; technique survival; patient survival

Outcome Measures

Primary Outcomes (1)

• Home dialysis survival

  Time to first patient death or home dialysis technique failure for each home dialysis modalities, censored for transplantation and loss to follow-up

  Survival analysis; specific analysis at 5 years after dialysis initiation

Secondary Outcomes (2)

• Patient survival, censored for technique failure

  Survival analysis, specific analysis at 1,2 5 years after dialysis initiation

• Home technique survival, censored for death

  survival analysis, specific analysis at 1,2 5 years after dialysis initiation

Other Outcomes (1)

• Home dialysis survival, case-control analysis

  survival analysis, specific analysis at 1,2 5 years after dialysis initiation

Study Arms (4)

Peritoneal dialysis only

Patient on PD modality 90 days after renal replacement therapy initiation and not transferred to HHD

Procedure: Peritoneal dialysis

Home hemodialysis only

Patient on HHD 90 days after renal replacement therapy initiation and not transferred to PD

Procedure: Home hemodialysis

PD and HHD

Patient on PD 90 days after RRT initiation and transferred to HHD less than 90 days after PD failure

Procedure: Peritoneal dialysis; Procedure: Home hemodialysis

HHD and PD

Patient on HHD after RRT initiation and transferred to PD less than 90 days after HHD failure

Procedure: Peritoneal dialysis; Procedure: Home hemodialysis

Interventions

Peritoneal dialysis PROCEDURE

HHD and PD; PD and HHD; Peritoneal dialysis only

Home hemodialysis PROCEDURE

HHD and PD; Home hemodialysis only; PD and HHD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with home dialysis as the first renal replacement therapy \[RRT\] modality (defined by the dialysis modality at 90 days) in Australia and New Zealand as reported in Australia and New Zealand Dialysis and Transplant Registry \[ANZDATA\]

You may qualify if:

• Patients with PD/HHD 90 days after RRT initiation between January 1, 2000 and December 31, 2012 reported in ANZDATA
• ≥ 18 years

You may not qualify if:

• Less than 90 days of dialysis
• \< 18 years
• Patients transferred to Australia/New Zealand after initiation of dialysis in another country

Sponsors & Collaborators

• Princess Alexandra Hospital, Brisbane, Australia: lead
• Baxter Healthcare Corporation: collaborator

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Peritoneal Dialysis; Hemodialysis, Home

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Renal Dialysis; Renal Replacement Therapy; Therapeutics; Sorption Detoxification; Home Care Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Metro South and Ipswich Nephrology and Transplant Services (MINTS) Medical Director, Queensland Renal Transplant Services Professor of Medicine (University of Qld)

Study Record Dates

• First Submitted: June 19, 2014
• First Posted: October 29, 2014
• Study Start: January 1, 2000
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: October 29, 2014

Record last verified: 2014-10