Clinical benefits and safety of a continuous ambulatory peritoneal dialysis (CAPD) technique with one icodextrin-containing and two glucose-containing dialysates a day in incident CAPD patients
| ISRCTN | ISRCTN23727549 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23727549 |
| Secondary identifying numbers | KCMC08MI035 |
- Submission date
- 01/06/2011
- Registration date
- 21/06/2011
- Last edited
- 20/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims:
Peritoneal dialysis is a type of dialysis that uses the inside lining of the abdomen (the peritoneum) as a filter to remove waste products and excess fluid from the blood when the kidneys stop working properly. Continuous ambulatory peritoneal dialysis (CAPD) is where the blood is filtered several times during the day. The conventional CAPD technique involves four exchanges of glucose dialysate fluid per day. Icodextrin is a glucose polymer that has been developed to improve filtration with fewer side effects (e.g. high blood sugar) than glucose solutions. A three daily exchange-CAPD technique using one icodextrin-containing and two glucose-containing dialysates may better preserve residual kidney function and be less harmful. The aim of this study is to evaluate the benefits of a three daily exchange-CAPD technique using one icodextrin-containing and two glucose-containing dialysates in new CAPD patients.
Who can participate?
Patients with end-stage kidney disease who are starting CAPD
What does the study involve?
After joining the study, participants use four exchanges of glucose-containing dialysates a day. After one month, they are randomly allocated to one of two groups. One group uses four exchanges of glucose-containing dialysates a day. The other group uses one icodextrin solution and two glucose-based dialysates a day. All participants attend visits for tests every month up to 12 months. Residual kidney function and other factors are assessed at the start of the study and after 6 and 12 months.
What are the possible benefits and risks of participating?
There are no risks for the participants because the participants are patients who are starting CAPD and therefore have residual kidney function.
Where is the study run from?
The eight affiliated hospitals of the Catholic University of Korea (South Korea)
When is the study starting and how long is it expected to run for?
April 2008 to October 2010
Who is funding the project?
The Catholic University of Korea (South Korea)
Who is the main contact?
Dr Yong-Soo Kim
Contact information
Scientific
Department of Internal Medicine
Seoul St. Mary's Hospital
The Catholic University of Korea
505 Banpo-Dong, Seocho-Gu
Seoul
137-701
Korea, South
Study information
| Study design | Multicentre prospective randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Comparison of benefits and safety between a CAPD technique with one icodextrin containing and two glucose containing dialysate a day and a CAPD technique with four exchanges of glucose-containing dialysates: a multicentre, prospective, randomized controlled trial |
| Study objectives | The use of more biocompatible solutions has been suggested to preserve peritoneal membrane integrity. Icodextrin is a glucose polymer developed to enhance ultrafiltration in patients with high solute transport. The high molecular weight of icodextrin creates colloid oncotic pressure, which promotes ultrafiltration for a longer time than does dextrose. In addition, the lower carbohydrate load of icodextrin induces less hyperglycemia, hyperinsulinemia, and dyslipidemia than glucose solutions. Based on the characteristics of icodextrin, we hypothesized that a three daily exchange-CAPD technique using one icodextrin-containing and two glucose-containing dialysates may better preserve residual renal function and may be more biocompatible compared to the CAPD technique using four exchanges of glucose solutions in new CAPD patients, who have residual renal function (RRF). The purpose of the present study was to evaluate the clinical benefits of a three daily exchange-CAPD technique using one icodextrin-containing and two glucose-containing dialysates in terms of residual renal function, biocompatibility, and dialysis adequacy in incident CAPD patients. |
| Ethics approval(s) | Catholic Medical Center, Office of Human Research Protection, 14/03/2008, Protocol number: KCMC08MI035 |
| Health condition(s) or problem(s) studied | End stage renal disease/ continuous ambulatory peritoneal dialysis (CAPD) |
| Intervention | 1. After enrollment, patients used four exchanges of glucose-containing dialysates a day 2. After one month, patients were randomly assigned to one of the two groups 3. Control group (GLU) used four exchanges of glucose-containing dialysates a day 4. Treatment group (ICO) used one icodextrin solution for the long dwell (12h) and two exchanges of glucose-based dialysates a day 5. Liberal use of 1.5%, 2.5%, or 4.25% glucose-based dialysates was allowed in both groups to achieve adequate control of edema and blood pressure 6. Visits were scheduled every month, and clinical evaluations were done in each visit 7. Peritoneal equilibration test was done at 0 month. Laboratory assessments were done at 0 month and every three months for hematological data as well as serum chemistry data 8. Urine and peritoneal effluent samples were analyzed every six months for glucose, urea, and creatinine levels 9. 24h peritoneal effluent samples were analyzed for cancer antigen 125 (CA125) levels 10. Plain radiographs for chest were taken every six months 11. The study period was 12 months after randomization |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Residual renal function (24h urine volume and renal creatinine clearance) at baseline, 6 months and 12 months 2. Ultrafiltration volume at baseline, 6 months and 12 months 3. Peritoneal glucose absorption at baseline, 6 months and 12 months 4. Peritoneal effluent CA125 levels at baseline, 6 months and 12 months |
| Secondary outcome measures | 1. Dialysis adequacy (weekly Kt/Vurea and normalized protein equivalent of nitrogen appearance) at baseline, 6 months and 12 months 2. Use of anti-lipid drugs at baseline, 6 months and 12 months 3. Insulin requirements at baseline, 6 months and 12 months 4. Cardiothoracic index on chest radiographs at baseline, 6 months and 12 months 5. Body weight at baseline, 6 months and 12 months 6. Events of peritonitis during 12 months 7. Events of cardiovascular disease during 12 months |
| Overall study start date | 14/04/2008 |
| Completion date | 20/10/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 78 |
| Key inclusion criteria | End-stage renal disease patients starting continuous ambulatory peritoneal dialysis (CAPD) |
| Key exclusion criteria | 1. Bedridden status 2. Dependency on tube feeding 3. Advanced liver cirrhosis 4. Current malignancy |
| Date of first enrolment | 14/04/2008 |
| Date of final enrolment | 20/10/2010 |
Locations
Countries of recruitment
- Korea, South
Study participating centre
137-701
Korea, South
Sponsor information
University/education
Catholic Medical Center
Clinical Research Coordination Center
505 Banpo-Dong Seocho-Gu
Seoul
137-701
Korea, South
"ROR" |
https://ror.org/01fpnj063 |
|---|
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- The Catholic University of Korea, 가톨릭 대학교, CUK
- Location
- Korea, South
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2014 | Yes | No |
Editorial Notes
20/10/2017: Plain English summary added.
