Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000674033
Ethics application status
Approved
Date submitted
27/04/2010
Date registered
17/08/2010
Date last updated
17/08/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Need for dialysis access procedures among patients receiving peritoneal dialysis and hemodialysis
Scientific title
Among patients who choose between peritoneal dialysis and hemodialysis, does the initial access type influence access related adverse events?
Secondary ID [1] 252466 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
end stage renal disease 243773 0
Condition category
Condition code
Renal and Urogenital 256832 256832 0 0
Kidney disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Incident patients with end stage renal disease (ESRD) who are eligible for both are offerred peritoneal dialysis (PD) or hemodialysis (HD). The PD group has access to up to two nursing visits a day to assisted with PD (primarily cycler PD).

Peritoneal dialysis is treatment by continuous ambulatory PD or automated PD.

Hemodialysis is intermittent treatments usually three times per week but patients could receive more treatments per week if clinically indicated.

Observation was from the start of dialysis to the end of dialysis (transplant, death) or lost to follow-up or end of the study.
Intervention code [1] 257025 0
Not applicable
Comparator / control treatment
Patients who receive any form of chronic hemodialysis as their treatment modality including incenter, satellite, or home dialysis.

Observation was from the start of dialysis to the end of dialysis (transplant, death) or lost to follow-up or end of the study. The minimum follow-up was six months. The mean follow-up is likely to be about 1.5 years.
Control group
Active

Outcomes
Primary outcome [1] 240842 0
The rate of invasive procedures to maintain access for dialysis. Primary nurse review the medical record every 3 months and record any invasive access procedures that occurred into a web-based database that is double reviewed by the investigators. All procedures must be referenced to medical records.
Timepoint [1] 240842 0
Observation was from the start of dialysis to the end of dialysis (transplant, death) or lost to follow-up or end of the study. It varied only depending on the above events and is not likely to vary much per group.

Study follow-up is variable - minimum follow-up is six months
Primary outcome [2] 259001 0
Number of invasive access procedures
Timepoint [2] 259001 0
Minimum follow-up is 6 months. Median follow-up should be approximately 1.5 years.
Secondary outcome [1] 257512 0
Access-related hospitalizations. Nurses entered invasive interventions, hospitalizations (duration and reason for admission) and death every three months based on reviewing the medical record. All data was reviewed by investigators every three months using a web-based system to ensure outcomes were recorded using a standardized classification system. The primary sources of data were surgical and radiological procedure notes and discharge summaries but the entire medical record could be reviewed as necessary. If the cause was not clear during the review process every three months it will be arbritrated by the two investigators at the end of the study. It was not blinded because the knowledge of first access attempted (fistula, PD catheter, or HD catheter) was often known at the time of the event.
Timepoint [1] 257512 0
Minimum follow-up is 6 months. Median follow-up should be approximately 1.5 years.
Secondary outcome [2] 265231 0
Access-related death
Timepoint [2] 265231 0
Minimum follow-up is 6 months. Median follow-up should be approximately 1.5 years.

Eligibility
Key inclusion criteria
1) Written or verbal diagnosis of stage 5 chronic kidney disease or end stage renal disease by nephrologist initiated dialysis therapy

3) Eligible for both peritoneal dialysis and hemodialysis.

3) Lives in region and residence where home care assistance for peritoneal dialysis is available.
Minimum age
18 Years
Maximum age
120 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Determined to be a prevalent (not incident) dialysis patient defined as having received dialysis for greater than three months any time prior to assessment or having received a previous kidney transplant

2) Died, withdrew from dialysis, or moved out of region prior to completing multidisciplinary assessment

3) Recovered renal function and discontinued dialysis

4) Refused to participate in a complete multidisciplinary assessment for modality eligibility

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
412
Accrual to date
Final
Recruitment outside Australia
Country [1] 2095 0
Canada
State/province [1] 2095 0

Funding & Sponsors
Funding source category [1] 243675 0
Government body
Name [1] 243675 0
Canadian Institutes of Health Research
Country [1] 243675 0
Canada
Primary sponsor type
Government body
Name
Canadian Institutes of Health Research
Address
160 Elgin Street, 9th Floor
Address Locator 4809A
Ottawa, ON, K1A 0W9
Country
Canada
Secondary sponsor category [1] 251706 0
Government body
Name [1] 251706 0
Minstry of Health and Long Term Care of Ontario
Address [1] 251706 0
M-1B114, Macdonald Block
900 Bay Street
Toronto ON M7A 1N3
Canada
Country [1] 251706 0
Canada
Secondary sponsor category [2] 256703 0
None
Name [2] 256703 0
Address [2] 256703 0
Country [2] 256703 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The primary aim of this study is to compare the risk of access-related procedures between peritoneal dialysis and hemodialysis Procedures to maintain access to the peritoneum or the bloodstream are important measures of safety because they are caused by complications that “require intervention in order to prevent permanent impairment or damage”. This usually meets the definition of a serious adverse event because loss of access is a life-threatening event for a chronic dialysis patient.
Trial website
Trial related presentations / publications
M. J. Oliver, R. R. Quinn, E. P. Richardson, A. J. Kiss, D. L. Lamping, and B. J. Manns. Home care assistance and the utilization of peritoneal dialysis. Kidney Int. 71 (7):673-678, 2007.

M. J. Oliver, A. X. Garg, P. G. Blake, J. F. Johnson, M. Verrelli, J. M. Zacharias, S. Pandeya, and R. R. Quinn. Impact of contraindications, barriers to self-care and support on incident peritoneal dialysis utilization. Nephrol.Dial.Transplant., 2010.

V. R. Williams, R. Quinn, S. Callery, A. Kiss, and M. J. Oliver. The impact of treatment modality on infection-related hospitalization rates in peritoneal dialysis and hemodialysis Perit.Dial.Int., 2010.
Public notes

Contacts
Principal investigator
Name 30227 0
Address 30227 0
Country 30227 0
Phone 30227 0
Fax 30227 0
Email 30227 0
Contact person for public queries
Name 13474 0
Matthew J. Oliver
Address 13474 0
Room A239 2075 Bayview Avenue Toronto ON M4N 3M5
Country 13474 0
Canada
Phone 13474 0
+1 416-480-4755
Fax 13474 0
Email 13474 0
[email protected]
Contact person for scientific queries
Name 4402 0
Matthew J. Oliver
Address 4402 0
Room A239
2075 Bayview Avenue Toronto ON
M4N 3M5
Country 4402 0
Canada
Phone 4402 0
+1 416-480-4755
Fax 4402 0
Email 4402 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.