End Stage Renal DiseaseEQlipsNCT01209273
Comparison of Quality of Life on Automated Peritoneal Dialysis and Continuous Ambulatory Peritoneal Dialysis
An observational study of End Stage Renal Disease and Peritoneal Dialysis, run by Kyungpook National University Hospital at 11 sites in South Korea.
Trial summary
The objective of this study is to compare Quality of Life (QoL) between Automated Peritoneal Dialysis (APD) and Continuous Ambulatory Peritoneal Dialysis (CAPD). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- End Stage Renal Disease, Peritoneal Dialysis
- How many people
- 260 participants
- Where
- 11 sitesSouth Korea
- Study dates
- Oct 2010to Sep 2015
- Phase
- Observational
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Incident PD patients in Korea
Who may be able to join
- Male or female subjects at least 20 and older at that time of obtaining informed consent
- Subjects performing CAPD or APD
- Subject with a total Kt/V≥ 1.7 at baseline
Who cannot join
- Subjects who have undergone abdominal surgery within the last 30 days except for PD catheter insertion
- Subjects who is planned for renal transplantation or hemodialysis within 1 year following the date of informed consent
- Subjects who have received antibiotics for the treatment of peritonitis, exit-site or tunnel infection within the last 30 days
- Subjects who have active liver disease such as cirrhosis of the liver, active hepatitis or other active liver disease as evidenced by biopsy, laboratory (unstable liver enzymes over the last 90 days) or clinical examination.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
South Korea11 sites
Inje University Haeundae Paik Hospital
Busan, 614-735
Samsung Changwon Hospital
Changwon, 630-520
Chungbuk National University Hospital
Cheongju-si, 361-790
Kyungpook National University Hospital
Daegu, 700-721
Daegu Fatima Hospital
Daegu, 701-600
Eulji University Hospital
Daejeon, 302-799
Chosun University Hospital
Gwangju, 501-717
Jeju National University Hospital
Jeju City
Korea University Anam Hospital
Seoul, 136-705
Eulji General Hospital
Seoul, 139-711
St. Carolo Hospital
Suncheon, 501-757
About this study
Official title: Prospective, Observational and Multi-center Study of a Comparison of Quality of Life on Automated Peritoneal Dialysis and Continuous Ambulatory Peritoneal Dialysis
The objective of this study is to compare Quality of Life (QoL) between Automated Peritoneal Dialysis (APD) and Continuous Ambulatory Peritoneal Dialysis (CAPD).
Read the detailed description
Automated peritoneal dialysis (APD) was first described in 1981, 5 years after the introduction of continuous ambulatory peritoneal dialysis (CAPD). It is increasingly used increasingly used in comparison with CAPD from 20% in 1995 to more than 33% of PD patients in North America in 1998, and in 2000, 54% of PD patients in the United States performed some form of APD.
APD has been several advantages over CAPD such as reduced incidence of peritonitis, mechanical complications and greater psychosocial acceptability. Many studies demonstrated a benefit for APD. In one Mexican retrospective study, APD has a better technical survival than CAPD with improvement of 1st peritonitis episode and French registry data showed the better peritonitis-free probability and autonomy in APD compared to CAPD. One study found that peritonitis rates and hospitalization were significantly less in patients on APD when results were expressed as episode/patient-year. Also a small randomized clinical trial comparing APD and CAPD showed that APD can help to keep selected patients vocationally or socially active.
Although APD has been expected to improve better condition of peritoneal dialysis patients, convincing evidence of major advantages is lacking and a benefit for APD is not demonstrated.
In three of randomized clinical trials, APD, APD did not differ from CAPD with respect to mortality (RR 1.49, 95% CI 0.51 to 4.37), risk of peritonitis(RR 0.75, 95% CI 0.50 to 1.11), switching from original PD modality to a different dialysis modality(RR 0.50, 95% CI 0.25 to 1.02), hernias(RR 1.26, 95% CI 0.32 to 5.01), PD fluid leaks(RR 1.06, 95% CI 0.11 to 9.83), PD catheter removal ( RR 0.64, 95% CI 0.27 to 1.48) or hospital admissions (RR0.96, 95% CI 0.43 to 2.17). In addition APD has potential disadvantages compared with CAPD like a possible faster in residual renal function, less sodium removal and more peritoneal protein loss and more expensive than CAPD. All of three large cohorts, NECOSAD, USRDS and ANZDATA showed that the risk of technical failure was not different between APD and CAPD but similar.
Because results on comparison between APD and CAPD is vague, prospective, observational and multi-center study in incident patients are required to gain more insight into survival on APD compared with CAPD in the course of peritoneal dialysis.
Quality of Life is an important outcome parameter when advising patients on renal replace treatment modality section. The introduction of a machine to assist the patient with PD exchanges can potentially improve quality of life in different ways. De Wit et al. analyzed health-related quality of life (HRQOL) in 37 APD and 59 CAPD patients from 16 different Dutch dialysis centers. In a multivariate analysis, the mental health was found to be better in APD as compared to CAPD patients. In addition, there were indications that APD patient tended to be less depressed and anxious than CAPD patients. In a prospective randomized trial, Bro et al. found no difference between CAPD and APD patients in quality of life measures. However APD patient tended to have more time for work, family, and social activities as compared to CAPD patients.
From these limited data, it can possibly be concluded that quality of life is very important to evaluate the lifestyle of the patient and to adapt the PD regimen.
Therefore, quality of life (QoL) assessment is expected to evidence to support the hypothesis that APD is superior to CAPD.
And the incidences of clinical events treatment modality change, peritonitis episode, exit site/tunnel infection, hospitalization, death, cancer development) are also reviewed to support that hypothesis.
- Conditions
- End Stage Renal Disease, Peritoneal Dialysis
- Keywords
- Quality of Life, Automated Peritoneal Dialysis, Continuous Ambulatory Peritoneal Dialysis, End Stage Renal Disease
- 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.
| Study group | Role | What they receive |
|---|---|---|
| APD group | which can be 3 to 5 exchanges daily, and up to 20 liters daily( including up to two daytime exchanges) | |
| CAPD group | which can be 1 to 4 exchanges daily and up to 16 liters daily(including up to two daytime exchanges) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Life
change in quality of life and patient satisfaction scores from start to dialysis to 1yr between APD group and CAPD group.
Measured: 1yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionFeb 2013
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Research Center for End Stage Renal Disease, Korea, Baxter Healthcare Corporation
- Responsible party
- Principal investigator, Yong-Lim Kim, Kyungpook National University Hospital
- Investigators
- Yong-Lim Kim, M.D., Ph.D., Principal investigator, Division of Nephrology, Department of Internal Medicine, Kyungpook National University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01209273
- Sponsor's protocol ID
- A-01
- Acronym
- EQlips
- Status last verified
- Sep 2015
- First submitted
- 24 Sep 2010
- Last updated
- 15 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Observational and Multi-center Study of a Comparison of Quality of Life on Automated Peritoneal Dialysis and Continuous Ambulatory Peritoneal Dialysis
- ClinicalTrials.gov ID
- NCT01209273
- Acronym / sponsor ID
- EQlips / A-01
- Conditions
- End Stage Renal Disease, Peritoneal Dialysis
- Keywords
- Quality of Life, Automated Peritoneal Dialysis, Continuous Ambulatory Peritoneal Dialysis, End Stage Renal Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Collaborators
- Clinical Research Center for End Stage Renal Disease, Korea, Baxter Healthcare Corporation
- Study start
- Oct 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 27 Sep 2010 (estimated)
- 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.
The objective of this study is to compare Quality of Life (QoL) between Automated Peritoneal Dialysis (APD) and Continuous Ambulatory Peritoneal Dialysis (CAPD).
Detailed description
Automated peritoneal dialysis (APD) was first described in 1981, 5 years after the introduction of continuous ambulatory peritoneal dialysis (CAPD). It is increasingly used increasingly used in comparison with CAPD from 20% in 1995 to more than 33% of PD patients in North America in 1998, and in 2000, 54% of PD patients in the United States performed some form of APD.
APD has been several advantages over CAPD such as reduced incidence of peritonitis, mechanical complications and greater psychosocial acceptability. Many studies demonstrated a benefit for APD. In one Mexican retrospective study, APD has a better technical survival than CAPD with improvement of 1st peritonitis episode and French registry data showed the better peritonitis-free probability and autonomy in APD compared to CAPD. One study found that peritonitis rates and hospitalization were significantly less in patients on APD when results were expressed as episode/patient-year. Also a small randomized clinical trial comparing APD and CAPD showed that APD can help to keep selected patients vocationally or socially active.
Although APD has been expected to improve better condition of peritoneal dialysis patients, convincing evidence of major advantages is lacking and a benefit for APD is not demonstrated.
In three of randomized clinical trials, APD, APD did not differ from CAPD with respect to mortality (RR 1.49, 95% CI 0.51 to 4.37), risk of peritonitis(RR 0.75, 95% CI 0.50 to 1.11), switching from original PD modality to a different dialysis modality(RR 0.50, 95% CI 0.25 to 1.02), hernias(RR 1.26, 95% CI 0.32 to 5.01), PD fluid leaks(RR 1.06, 95% CI 0.11 to 9.83), PD catheter removal ( RR 0.64, 95% CI 0.27 to 1.48) or hospital admissions (RR0.96, 95% CI 0.43 to 2.17). In addition APD has potential disadvantages compared with CAPD like a possible faster in residual renal function, less sodium removal and more peritoneal protein loss and more expensive than CAPD. All of three large cohorts, NECOSAD, USRDS and ANZDATA showed that the risk of technical failure was not different between APD and CAPD but similar.
Because results on comparison between APD and CAPD is vague, prospective, observational and multi-center study in incident patients are required to gain more insight into survival on APD compared with CAPD in the course of peritoneal dialysis.
Quality of Life is an important outcome parameter when advising patients on renal replace treatment modality section. The introduction of a machine to assist the patient with PD exchanges can potentially improve quality of life in different ways. De Wit et al. analyzed health-related quality of life (HRQOL) in 37 APD and 59 CAPD patients from 16 different Dutch dialysis centers. In a multivariate analysis, the mental health was found to be better in APD as compared to CAPD patients. In addition, there were indications that APD patient tended to be less depressed and anxious than CAPD patients. In a prospective randomized trial, Bro et al. found no difference between CAPD and APD patients in quality of life measures. However APD patient tended to have more time for work, family, and social activities as compared to CAPD patients.
From these limited data, it can possibly be concluded that quality of life is very important to evaluate the lifestyle of the patient and to adapt the PD regimen.
Therefore, quality of life (QoL) assessment is expected to evidence to support the hypothesis that APD is superior to CAPD.
And the incidences of clinical events treatment modality change, peritonitis episode, exit site/tunnel infection, hospitalization, death, cancer development) are also reviewed to support that hypothesis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APD group | – | –which can be 3 to 5 exchanges daily, and up to 20 liters daily( including up to two daytime exchanges) |
| CAPD group | – | –which can be 1 to 4 exchanges daily and up to 16 liters daily(including up to two daytime exchanges) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Incident PD patients in Korea
Key inclusion criteria (3 listed)
- Male or female subjects at least 20 and older at that time of obtaining informed consent
- Subjects performing CAPD or APD
- Subject with a total Kt/V≥ 1.7 at baseline
Key exclusion criteria (4 listed)
- Subjects who have undergone abdominal surgery within the last 30 days except for PD catheter insertion
- Subjects who is planned for renal transplantation or hemodialysis within 1 year following the date of informed consent
- Subjects who have received antibiotics for the treatment of peritonitis, exit-site or tunnel infection within the last 30 days
- Subjects who have active liver disease such as cirrhosis of the liver, active hepatitis or other active liver disease as evidenced by biopsy, laboratory (unstable liver enzymes over the last 90 days) or clinical examination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Quality of Life
Time frame: 1yr
change in quality of life and patient satisfaction scores from start to dialysis to 1yr between APD group and CAPD group.
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 15 Sep 2015.
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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.
Yong-Lim Kim, M.D., Ph.D. principal investigator
Division of Nephrology, Department of Internal Medicine, Kyungpook National University School of Medicine
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Renal Disease and Peritoneal Dialysis, run by Kyungpook National University Hospital at 11 sites in South Korea.
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 3 inclusion and 4 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 15 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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: 1yr). 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 15 Sep 2015.