Cardiac function in automated peritoneal dialysis patients
| ISRCTN | ISRCTN14931270 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14931270 |
| Secondary identifying numbers | 08CEC2AP002 |
- Submission date
- 23/03/2018
- Registration date
- 30/04/2018
- Last edited
- 29/05/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
In end-stage kidney disease, the kidney is unable to remove waste from the blood. Consequently, replacement therapy for kidney function has to be initiated. Peritoneal dialysis (PD) is one of several kidney replacement therapies. A PD catheter (tube) is implanted into the abdomen before PD commencement. Then glucose (sugar) solution is pumped into the abdominal cavity using the PD catheter and is allowed to remain for for 4-6 hours before being pumped out. Generally, the procedure has to be repeated 4 times a day. Uremic (nitrogen-containing) toxins and excessive water are removed via osmosis by glucose solution. Another type of PD therapy is called automated peritoneal dialysis (APD), in which a machine pumps PD solution in and out automatically in the night or daytime. The therapeutic duration is around 8-12 hours depending on doctor prescription. The benefit is the avoidance of frequent manual exchanges by patients especially in the daytime. The capacity of fluid removed by glucose solution varies depending on individual's condition. There might be a fluid burden to the heart if not enough water is removed during PD. Icodextrin is a glucose polymer (chain) demonstrating a high capacity for water removal from the abdominal cavity and a long dwell time (10-12 hours retention in the abdominal cavity). Therefore, the proposal is that icodextrin use might achieve better water removal than glucose PD solution, and result in better heart function. The aim in the present trial is attempt to compare heart function between two groups, icodextrin solution or glucose solution in people undergoing APD.
Who can participate?
Adults treated with PD for end-stage kidney disease
What does the study involve?
The trial is two arms, one uses icodextrin solution in the daytime, another arm uses glucose solution in the daytime. All participants use glucose solution for PD therapy in the night with APD regimen.
What are the possible benefits and risks of participating?
The expected benefit in this trial is better water removal, resulting in better heart function in participants in the icodextrin group. Reported side effects in icodextrin solution are rare, but include allergic skin reactions and abdominal swelling. The side effect is easily controlled by stopping icodextrin solution use and managing symptoms.
Where is the study run from?
PD unit in Kaohsiung Chang Gung Memorial Hospital in Taiwan
When is the study starting and how long is it expected to run for?
The trial began in June 2009 and was completed in May 2015.
Who is funding the study?
This work is supported by Baxter-Clinical Evidence Council (CEC) Fund
Who is the main contact?
Dr Jin-Bor Chen
jbchen@cgmh.org.tw
Contact information
Scientific
123 Da Pei Rd, Niao Song Dist
Kaohsiung
833
Taiwan
| Phone | +88677317123 |
|---|---|
| chenjb1019@gmail.com |
Study information
| Study design | Single-center randomized case-control trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | A longitudinal changes of cardiac function with icodextrin in automated peritoneal dialysis patients |
| Study objectives | We hypothesized that the use of icodextrin (ICO) in peritoneal dialysis therapy has an advantage in cardiac function via sustained ultrafiltration compared to glucose (GLU)-based solution. |
| Ethics approval(s) | The study protocol was approved by the Committee on Human Research at Kaohsiung Chang Gung Memorial Hospital (98-0390B)(March,2009) |
| Health condition(s) or problem(s) studied | End-stage kidney disease patients treated with automated peritoneal dialysis (APD) |
| Intervention | We used a purposive sampling method to enroll study participants in the outpatient department. After the study protocol was explained and informed consent was obtained, we used a computer-generated block randomization method to categorize enrolled participants into two groups. All of the participants underwent nocturnal APD with varying concentrations of glucose-based PD solutions and icodextrin PD solution depending on the prescription from their respective nephrologists. The duration of treatment is 2 years in each subject, and length of follow-up is 2 years. |
| Intervention type | Other |
| Primary outcome measure | Cardiac structure and function are measured using echocardiography at baseline, 1 year and 2 years. |
| Secondary outcome measures | Hospitalization for heart failure in the study period measured by patient medical records review. |
| Overall study start date | 01/03/2009 |
| Completion date | 31/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 50 |
| Total final enrolment | 43 |
| Key inclusion criteria | 1. Agreed to receive nocturnal APD regimen with daytime dwell of at least 10 h |
| Key exclusion criteria | 1. Starch allergy 2. Glycogen storage disease 3. Life expectancy of <12 months 4. Serious disease within 30 days before randomization 5. Pregnancy or lactation 6. Significant psychiatric disorder that would interfere with their ability to provide informed consent and/or comply with the study procedures. |
| Date of first enrolment | 31/03/2009 |
| Date of final enrolment | 31/12/2010 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
Kaohsiung
833
Taiwan
Sponsor information
Industry
not available in website
not available in website
not available in website
United States of America
| Website | baxter.com |
|---|---|
"ROR" |
https://ror.org/02d6ew870 |
Funders
Funder type
Not defined
No information available
Results and Publications
| Intention to publish date | 31/12/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Jin-Bor Chen (chenjb1019@gmail.com) until December 2019. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 08/05/2018 | 16/01/2019 | Yes | No |
Editorial Notes
29/05/2019: The total final enrolment was added.
17/01/2019: IPD sharing statement added.
16/01/2019: Publication reference added.
