Designer Dialysis Peritoneal Dialysis

NCT03100188 | Completed

• 1 other identifier: IRB#9421
• Study Type: interventional
• Target: 7
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Peritoneal Dialysis; Quality of Life

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• change in residual renal kt/v

  30 days after enrollment, and then every 3 months for a total of 12 months after enrollment.

• 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

  30 days after enrollment, and then every 3 months for a total of 12 months after enrollment.

• change in serum albumin

  monthly for 12 months after enrollment

• change in 24 hour urine output

  monthly for 12 months after enrollment

Study Arms (1)

modified PD

EXPERIMENTAL

Patients with residual renal kt/v were placed in intervention group

Other: modified PD prescription

Interventions

modified PD prescription OTHER

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.

modified PD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Louisiana State University Health Sciences Center in New Orleans: lead

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mihran Naljayan, MD

  LSU School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

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

Study Record Dates

• First Submitted: March 12, 2017
• First Posted: April 4, 2017
• Study Start: July 1, 2015
• Primary Completion: September 30, 2016
• Study Completion: December 15, 2016
• Last Updated: April 4, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share