Peritoneal DialysisNCT03100188
Designer Dialysis Peritoneal Dialysis
A study testing modified PD prescription in people with Peritoneal Dialysis and Quality of Life, run by Louisiana State University Health Sciences Center in New Orleans.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Dialysis, Quality of Life
- What is being tested?
- modified PD prescription
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2015to 15 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients on either CAPD or CCPD and had both residual renal (RR) Kt/V ≥ 1.0 and total Kt/V values ≥ 1.7.
Who cannot join
- patients who did not meet the values of RR Kt/V and total Kt/V specified above
About this study
Official title: 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.
Read the 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.
- Conditions
- Peritoneal Dialysis, Quality of Life
- Being tested
- modified PD prescription
- Keywords
- peritoneal dialysis, incremental peritoneal dialysis, quality of life, end stage renal disease, adequacy
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified PD prescriptionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| modified PD | Experimental | Patients with residual renal kt/v were placed in intervention group Receives: Other: modified PD prescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in quality of life
change in survey results of modified KDQOL 36 survey
Measured: at the time of enrollment and again after 12 months
Secondary outcomes (5)
change in residual renal kt/v
change in RR kt/v
Measured: 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
Measured: 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
Measured: 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
Measured: monthly for 12 months after enrollment
change in 24 hour urine output
change in 24 hour urine output
Measured: monthly for 12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start1 Jul 2015
- Primary completion30 Sep 2016
- Study completion15 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- one cohort of patients who meet inclusion criteria had intervention and followed for 12 months
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mihran Naljayan, Louisiana State University Health Sciences Center in New Orleans
- Investigators
- Mihran Naljayan, MD, Principal investigator, LSU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03100188
- Sponsor's protocol ID
- IRB#9421
- Status last verified
- Mar 2017
- First submitted
- 12 Mar 2017
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Designer Dialysis: Designing a Peritoneal Dialysis Prescription That Fits a Patient's Lifestyle
- ClinicalTrials.gov ID
- NCT03100188
- Acronym / sponsor ID
- IRB#9421
- Conditions
- Peritoneal Dialysis, Quality of Life
- Keywords
- peritoneal dialysis, incremental peritoneal dialysis, quality of life, end stage renal disease, adequacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Louisiana State University Health Sciences Center in New OrleansUniversity, hospital or other
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 30 Sep 2016 (actual)
- Study completion
- 15 Dec 2016 (actual)
- First posted
- 4 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- one cohort of patients who meet inclusion criteria had intervention and followed for 12 months
| Arm | Type | Receives |
|---|---|---|
| modified PD | Experimental | Other: modified PD prescriptionPatients with residual renal kt/v were placed in intervention group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients on either CAPD or CCPD and had both residual renal (RR) Kt/V ≥ 1.0 and total Kt/V values ≥ 1.7.
Key exclusion criteria (1 listed)
- patients who did not meet the values of RR Kt/V and total Kt/V specified above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| modified PD prescriptionFor 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. | Other | modified PD |
Primary outcome
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
5 secondary outcomes
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 PD 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
Time frame: 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 24 hour urine output
Time frame: monthly for 12 months after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
- Individual participant dataSharing planned: No
Related trials for Peritoneal Dialysis
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Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
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Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients
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Continuous Glucose Monitoring in Patients With Diabetes on Peritoneal Dialysis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mihran Naljayan, MD principal investigator
LSU School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing modified PD prescription in people with Peritoneal Dialysis and Quality of Life, run by Louisiana State University Health Sciences Center in New Orleans.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in quality of life (time frame: at the time of enrollment and again after 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017.