Comparison of Quality of Life on Automated Peritoneal Dialysis and Continuous Ambulatory Peritoneal Dialysis

NCT01209273 | Completed DMC

• 1 other identifier: A-01
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 11

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).

Conditions

End Stage Renal Disease; Peritoneal Dialysis

Keywords

Quality of Life; Automated Peritoneal Dialysis; Continuous Ambulatory Peritoneal Dialysis; End Stage Renal Disease

Outcome Measures

Primary Outcomes (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.

  1yr

Study Arms (2)

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)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Incident PD patients in Korea

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kyungpook National University Hospital: lead
• Clinical Research Center for End Stage Renal Disease, Korea: collaborator
• Baxter Healthcare Corporation: collaborator

Study Sites (11)

Inje University Haeundae Paik Hospital

Busan, 614-735, South Korea

Location

Samsung Changwon Hospital

Changwon, 630-520, South Korea

Location

Chungbuk National University Hospital

Cheongju-si, 361-790, South Korea

Location

Kyungpook National University Hospital

Daegu, 700-721, South Korea

Location

Daegu Fatima Hospital

Daegu, 701-600, South Korea

Location

Eulji University Hospital

Daejeon, 302-799, South Korea

Location

Chosun University Hospital

Gwangju, 501-717, South Korea

Location

Jeju National University Hospital

Jeju City, South Korea

Location

Korea University Anam Hospital

Seoul, 136-705, South Korea

Location

Eulji General Hospital

Seoul, 139-711, South Korea

Location

St. Carolo Hospital

Suncheon, 501-757, South Korea

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood 24hr urine PD dialysate

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yong-Lim Kim, M.D., Ph.D.

  Division of Nephrology, Department of Internal Medicine, Kyungpook National University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 24, 2010
• First Posted: September 27, 2010
• Study Start: October 1, 2010
• Primary Completion: February 1, 2013
• Study Completion: September 1, 2015
• Last Updated: September 15, 2015

Record last verified: 2015-09

Locations

KR (11)