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Designer Dialysis Peritoneal Dialysis

Designer Dialysis: Designing a Peritoneal Dialysis Prescription That Fits a Patient's Lifestyle

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03100188
Enrollment
7
Registered
2017-04-04
Start date
2015-07-01
Completion date
2016-12-15
Last updated
2017-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peritoneal Dialysis, Quality of Life

Keywords

peritoneal dialysis, incremental peritoneal dialysis, quality of life, end stage renal disease, adequacy

Brief summary

This study aims to use modified peritoneal dialysis prescriptions to achieve adequate clearance and volume removal while decreasing the number of exchanges or time spent on dialysis, evaluating maintenance of residual renal function, and improving quality of life.

Detailed description

Patient's currently on peritoneal dialysis at our program can be considered for this study. In order to be enrolled, patients patient's must have significant residual renal function defined as a renal Kt/V \>1.0. These patients will then be consented, and if agreeable, the participant's dialysis prescriptions will be modified to decrease their peritoneal dialysis. For patients on continuous ambulatory peritoneal dialysis (CAPD), this may mean less exchanges in a 24 hour period, or less exchanges over the course of the week (does not need to perform exchanges every day). Patients who are continuous cycler peritoneal dialysis (CCPD) will be modified to shorter cycler times, or also less cycles during the course of the week (does not need cycler therapy every day). Patients will need to continue achieving adequate weekly total Kt/V of greater than or equal to 1.7 as per national recommendations and the clinical guidelines within our unit. This is calculated using the residual renal (RR) Kt/v and the PD Kt/V. Patients will also perform monthly 24 hour urine collections for urinary volume, creatinine clearance, and urea clearance. Adequacy is typically measured every 3 months based on our internal lab requirements, but patients will need to perform adequacy measurements any time their prescription is changed. The investigators will measure monthly labs per routine including albumin, parathyroid hormone (PTH), serum phosphorus, and hemoglobin. The investigators hypothesize that patients will have a better quality of life (QoL) while on a modified dialysis prescription with less exchanges or less cycler time as assessed by the kidney disease quality of life (KDQOL-36) survey tool. The investigators believe that patients with higher levels of residual renal function (≥ 2 mL/min) can perform fewer peritoneal dialysis exchanges while still achieving and maintaining adequate clearance of solute and appropriate volume removal. The investigators also believe that by maximizing the use of the residual renal function, the investigators can adjust the peritoneal dialysis prescription by decreasing the numbers of manual exchanges per day, decreasing cycler time, or possibly decreasing the number of days of dialysis each week. With the benefit of less dialysis time or exchanges per day, the investigators believe patients will have a decreased burnout rate by allowing them to have a better QoL and not feel burdened by the dialysis therapy.

Interventions

OTHERmodified PD prescription

For patients on CAPD, fewer daily exchanges or fewer total weekly exchanges are prescribed. Patients on CCPD are prescribed shorter cycler time or fewer total cycles during the week.

Sponsors

Louisiana State University Health Sciences Center in New Orleans
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

one cohort of patients who meet inclusion criteria had intervention and followed for 12 months

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patients on either CAPD or CCPD and had both residual renal (RR) Kt/V ≥ 1.0 and total Kt/V values ≥ 1.7.

Exclusion criteria

* patients who did not meet the values of RR Kt/V and total Kt/V specified above

Design outcomes

Primary

MeasureTime frameDescription
change in quality of lifeat the time of enrollment and again after 12 monthschange in survey results of modified KDQOL 36 survey

Secondary

MeasureTime frameDescription
change in residual renal kt/v30 days after enrollment, and then every 3 months for a total of 12 months after enrollment.change in RR kt/v
change in PD Kt/V30 days after enrollment, and then every 3 months for a total of 12 months after enrollment.change in PD Kt/V
change in total kt/v30 days after enrollment, and then every 3 months for a total of 12 months after enrollment.change in total kt/v; this is calculated by adding RR kt/v and PD kt/v
change in serum albuminmonthly for 12 months after enrollmentchange in serum albumin level
change in 24 hour urine outputmonthly for 12 months after enrollmentchange in 24 hour urine output

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026