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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2012 by Kyungpook National University.
Recruitment status was  Recruiting
Clinical Research Center for End Stage Renal Disease, Korea
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Yong-Lim Kim, Kyungpook National University Identifier:
First received: September 24, 2010
Last updated: December 10, 2012
Last verified: December 2012

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

End Stage Renal Disease
Peritoneal Dialysis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Kyungpook National University:

Primary Outcome Measures:
  • Change in Quality of Life [ Time Frame: 1yr ] [ Designated as safety issue: No ]
    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

Estimated Enrollment: 300
Study Start Date: October 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
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)

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.


Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01209273

Contact: Ji-Young Choi, M.D. +82-10-8584-8557
Contact: Jung-Ju Seo, MS +82-53-420-6306

Korea, Republic of
Inje University Haeundae Paik Hospital Recruiting
Busan, Korea, Republic of, 614-735
Contact: Yang Wook Kim, M.D.    +82-51-890-6075   
Samsung Changwon Hospital Recruiting
Changwon, Korea, Republic of, 630-520
Contact: Seong Cho, M.D.    +82-55-290-6029   
Chungbuk National University Hospital Recruiting
Cheongju, Korea, Republic of, 361-790
Contact: Hye-Young Kim, M.D.    +82-43-269-6017   
Daegu Fatima Hospital Recruiting
Daegu, Korea, Republic of, 701-600
Contact: Sung-Ho Kim, M.D.    +82-53-940-7221   
Kyungpook National University Hospital Recruiting
Daegu, Korea, Republic of, 700-721
Contact: Ji-Young Choi, M.D.    +82-10-8584-8557   
Contact: Jung-Ju Seo, MS    +82-53-420-6306   
Principal Investigator: Yong-Lim Kim, M.D., Ph.D.         
Eulji University Hospital Recruiting
Daejeon, Korea, Republic of, 302-799
Contact: Gi Tae Bang, M.D.    +82-42-611-3048   
Chosun University Hospital Not yet recruiting
Gwangju, Korea, Republic of, 501-717
Contact: Hyun Lee Kim, M.D.    +82-62-220-3178   
Jeju National University Hospital Recruiting
Jeju, Korea, Republic of
Contact: Eun Hee Jang, M.D.    +82-64-750-1253   
Eulji General Hospital Recruiting
Seoul, Korea, Republic of, 139-711
Contact: So Young Lee, M.D.    +82-2-970-8457   
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of, 136-705
Contact: Sang Kung Jo, M.D.    +82-2-920-5909   
St. Carolo Hospital Not yet recruiting
Suncheon, Korea, Republic of, 501-757
Contact: Jong Hyo Lee, M.D.    +82-62-720-2500   
Sponsors and Collaborators
Kyungpook National University
Clinical Research Center for End Stage Renal Disease, Korea
Baxter Healthcare Corporation
Principal Investigator: Yong-Lim Kim, M.D., Ph.D. Division of Nephrology, Department of Internal Medicine, Kyungpook National University School of Medicine
  More Information

No publications provided

Responsible Party: Yong-Lim Kim, Professor, Kyungpook National University Identifier: NCT01209273     History of Changes
Other Study ID Numbers: A-01
Study First Received: September 24, 2010
Last Updated: December 10, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Kyungpook National University:
Quality of Life
Automated Peritoneal Dialysis
Continuous Ambulatory Peritoneal Dialysis
End Stage Renal Disease

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases processed this record on August 27, 2015