Peritoneal Dialysis Daily Versus Six Days Per Week

The study will enroll patients receiving daily peritoneal dialysis who have significant residual native kidney function. The investiators will visit the patients at a routinely scheduled clinic visit and again at a non-routine visit after the patients skip a single day of dialysis. Blood samples will be obtained and a quality of life questionnaire will be administered at both visits.

The primary aim will be to determine whether the patients would prefer daily treatment or being allowed to skip one day per week.

Other aims will be to determine the effect of skipping a day on plasma levels of urea nitrogen and creatinine.

Study Overview

• Status: Withdrawn
• Conditions: Peritoneal Dialysis
• Intervention / Treatment: Other: Skip one day of peritoneal dialysis treatment

Detailed Description

The patients' preference will be assessed by asking the simple question would you prefer to perform peritoneal dialysis daily of six days per week.

The quality of life questionnaire to be used will be the Dialysis Symptom Index (DSI) which has a range of 0 to 150 with a high score reflecting worse quality of life.

The chemical to be measured will be the plasma urea nitrogen in mg/dl and the plasma creatinine in mg/dl as measured by the clinical laboratory.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Daily treament with peritoneal dialysis and residual native kidney funciton with residual urea clearance greater than 2 ml/min.

Exclusion Criteria:

• less than 3 months on peritoneal dialysis
• recent change in the dialysis prescriptoin
• recent peritonitis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Peritoneal Dialysis Daily; Each patient will compare their regular daily treatment with the effect of skipping a single day of treatment. There will be no other intervention.	Other: Skip one day of peritoneal dialysis treatment; Skip one day of peritoneal dialysis treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's preference for treatment regimen	Patient's stated preference for dialysis daily versus six days per week	Two weeks per patient

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptoms	Quality of Life as assessed by a questionnaire	Two weeks per patient
Plasma solute levels	Plasma levels of urea nitrogen and creatinine.	Two weeks per patient

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: April 28, 2024
• First Submitted That Met QC Criteria: May 2, 2024
• First Posted (Actual): May 6, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2025
• Last Update Submitted That Met QC Criteria: May 19, 2025
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 75365

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
• product manufactured in and exported from the U.S.: No