Designer Dialysis Peritoneal Dialysis

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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Peritoneal Dialysis
• Intervention / Treatment: Other: modified PD prescription

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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: modified PD; Patients with residual renal kt/v were placed in intervention group	Other: modified 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in quality of life	change in survey results of modified KDQOL 36 survey	at the time of enrollment and again after 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in residual renal kt/v	change in RR kt/v	30 days after enrollment, and then every 3 months for a total of 12 months after enrollment.
change in PD Kt/V	change in PD Kt/V	30 days after enrollment, and then every 3 months for a total of 12 months after enrollment.
change in total kt/v	change in total kt/v; this is calculated by adding RR kt/v and PD kt/v	30 days after enrollment, and then every 3 months for a total of 12 months after enrollment.
change in serum albumin	change in serum albumin level	monthly for 12 months after enrollment
change in 24 hour urine output	change in 24 hour urine output	monthly for 12 months after enrollment

Collaborators and Investigators

• Sponsor: Louisiana State University Health Sciences Center in New Orleans
• Investigators: Principal Investigator: Mihran Naljayan, MD, LSU School of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2015
• Primary Completion (ACTUAL): September 30, 2016
• Study Completion (ACTUAL): December 15, 2016

Study Registration Dates

• First Submitted: March 12, 2017
• First Submitted That Met QC Criteria: March 29, 2017
• First Posted (ACTUAL): April 4, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 4, 2017
• Last Update Submitted That Met QC Criteria: March 29, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: quality of life; peritoneal dialysis; adequacy; end stage renal disease; incremental peritoneal dialysis
• Other Study ID Numbers: IRB#9421

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No