eed for dialysis access procedures among patients receiving peritoneal dialysis and hemodialysis

Not Applicable

Recruiting

• Conditions: end stage renal disease; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12610000674033
• Lead Sponsor: Canadian Institutes of Health Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-08-17
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 412

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.

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

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of invasive access procedures[Minimum follow-up is 6 months. Median follow-up should be approximately 1.5 years.];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.[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. <br><br>Study follow-up is variable - minimum follow-up is six months]

Secondary Outcome Measures

Name	Time	Method
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.[Minimum follow-up is 6 months. Median follow-up should be approximately 1.5 years.];Access-related death[Minimum follow-up is 6 months. Median follow-up should be approximately 1.5 years.]