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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Kyungpook National University
Sponsor:
Collaborators:
Clinical Research Center for End Stage Renal Disease, Korea
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Yong-Lim Kim, Kyungpook National University
ClinicalTrials.gov Identifier:
NCT01209273
First received: September 24, 2010
Last updated: December 10, 2012
Last verified: December 2012
  Purpose

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


Condition
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)
Groups/Cohorts
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.

  Eligibility

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

Criteria

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 ClinicalTrials.gov identifier: NCT01209273

Contacts
Contact: Ji-Young Choi, M.D. +82-10-8584-8557 jyss1002@hanmail.net
Contact: Jung-Ju Seo, MS +82-53-420-6306 bravo2510@hanmail.net

Locations
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    kyw8625@chol.com   
Samsung Changwon Hospital Recruiting
Changwon, Korea, Republic of, 630-520
Contact: Seong Cho, M.D.    +82-55-290-6029    chaecho@kornet.net   
Chungbuk National University Hospital Recruiting
Cheongju, Korea, Republic of, 361-790
Contact: Hye-Young Kim, M.D.    +82-43-269-6017    hyekim@chungbuk.ac.kr   
Kyungpook National University Hospital Recruiting
Daegu, Korea, Republic of, 700-721
Contact: Ji-Young Choi, M.D.    +82-10-8584-8557    jyss1002@hanmail.net   
Contact: Jung-Ju Seo, MS    +82-53-420-6306    bravo2510@hanmail.net   
Principal Investigator: Yong-Lim Kim, M.D., Ph.D.         
Daegu Fatima Hospital Recruiting
Daegu, Korea, Republic of, 701-600
Contact: Sung-Ho Kim, M.D.    +82-53-940-7221    shkim@fatima.or.kr   
Eulji University Hospital Recruiting
Daejeon, Korea, Republic of, 302-799
Contact: Gi Tae Bang, M.D.    +82-42-611-3048    starryroom@hanmail.net   
Chosun University Hospital Not yet recruiting
Gwangju, Korea, Republic of, 501-717
Contact: Hyun Lee Kim, M.D.    +82-62-220-3178    hyunkim@chosun.ac.kr   
Jeju National University Hospital Recruiting
Jeju, Korea, Republic of
Contact: Eun Hee Jang, M.D.    +82-64-750-1253    lovemd@hanmail.net   
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of, 136-705
Contact: Sang Kung Jo, M.D.    +82-2-920-5909    sang-kyung@korea.ac.kr   
Eulji General Hospital Recruiting
Seoul, Korea, Republic of, 139-711
Contact: So Young Lee, M.D.    +82-2-970-8457    lsymd71@hanmail.net   
St. Carolo Hospital Not yet recruiting
Suncheon, Korea, Republic of, 501-757
Contact: Jong Hyo Lee, M.D.    +82-62-720-2500    everyrs@hanmail.net   
Sponsors and Collaborators
Kyungpook National University
Clinical Research Center for End Stage Renal Disease, Korea
Baxter Healthcare Corporation
Investigators
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
ClinicalTrials.gov 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
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on July 26, 2014