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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in South Korea

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.

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 groups in NCT01209273
Study groupRoleWhat they receive
APD groupwhich can be 3 to 5 exchanges daily, and up to 20 liters daily( including up to two daytime exchanges)
CAPD groupwhich 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.

  1. 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.

  1. First posted27 Sep 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionFeb 2013
  4. Study completionSep 2015

Resources

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)
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

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.

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