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Comparison of Quality of Life on Automated Peritoneal Dialysis and Continuous Ambulatory Peritoneal Dialysis (EQlips)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01209273
Recruitment Status : Completed
First Posted : September 27, 2010
Last Update Posted : September 15, 2015
Clinical Research Center for End Stage Renal Disease, Korea
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Yong-Lim Kim, Kyungpook National University Hospital

Brief Summary:
The objective of this study is to compare Quality of Life (QoL) between Automated Peritoneal Dialysis (APD) and Continuous Ambulatory Peritoneal Dialysis (CAPD).

Condition or disease
End Stage Renal Disease Peritoneal Dialysis

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.

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Study Type : Observational
Actual Enrollment : 260 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective, Observational and Multi-center Study of a Comparison of Quality of Life on Automated Peritoneal Dialysis and Continuous Ambulatory Peritoneal Dialysis
Study Start Date : October 2010
Actual Primary Completion Date : February 2013
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

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)

Primary Outcome Measures :
  1. 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.

Biospecimen Retention:   Samples Without DNA
blood 24hr urine PD dialysate

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Incident PD patients in Korea

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01209273

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Korea, Republic of
Inje University Haeundae Paik Hospital
Busan, Korea, Republic of, 614-735
Samsung Changwon Hospital
Changwon, Korea, Republic of, 630-520
Chungbuk National University Hospital
Cheongju, Korea, Republic of, 361-790
Kyungpook National University Hospital
Daegu, Korea, Republic of, 700-721
Daegu Fatima Hospital
Daegu, Korea, Republic of, 701-600
Eulji University Hospital
Daejeon, Korea, Republic of, 302-799
Chosun University Hospital
Gwangju, Korea, Republic of, 501-717
Jeju National University Hospital
Jeju, Korea, Republic of
Korea University Anam Hospital
Seoul, Korea, Republic of, 136-705
Eulji General Hospital
Seoul, Korea, Republic of, 139-711
St. Carolo Hospital
Suncheon, Korea, Republic of, 501-757
Sponsors and Collaborators
Kyungpook National University Hospital
Clinical Research Center for End Stage Renal Disease, Korea
Baxter Healthcare Corporation
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Principal Investigator: Yong-Lim Kim, M.D., Ph.D. Division of Nephrology, Department of Internal Medicine, Kyungpook National University School of Medicine
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Responsible Party: Yong-Lim Kim, Professor, Kyungpook National University Hospital Identifier: NCT01209273    
Other Study ID Numbers: A-01
First Posted: September 27, 2010    Key Record Dates
Last Update Posted: September 15, 2015
Last Verified: September 2015
Keywords provided by Yong-Lim Kim, Kyungpook National University Hospital:
Quality of Life
Automated Peritoneal Dialysis
Continuous Ambulatory Peritoneal Dialysis
End Stage Renal Disease
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency