Designer Dialysis Peritoneal Dialysis

March 29, 2017 updated by: Mihran Naljayan, Louisiana State University Health Sciences Center in New Orleans

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
change in quality of life
Time Frame: at the time of enrollment and again after 12 months
change in survey results of modified KDQOL 36 survey
at the time of enrollment and again after 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
change in residual renal kt/v
Time Frame: 30 days after enrollment, and then every 3 months for a total of 12 months after enrollment.
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
Time Frame: 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
Time Frame: 30 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
30 days after enrollment, and then every 3 months for a total of 12 months after enrollment.
change in serum albumin
Time Frame: monthly for 12 months after enrollment
change in serum albumin level
monthly for 12 months after enrollment
change in 24 hour urine output
Time Frame: monthly for 12 months after enrollment
change in 24 hour urine output
monthly for 12 months after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Louisiana State University Health Sciences Center in New Orleans

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mihran Naljayan, MD, LSU School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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