Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Jin-Bor Chen
ORCID ID
Contact details
123 Da Pei Rd
Niao Song Dist
Kaohsiung
833
Taiwan
+88677317123
chenjb1019@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
08CEC2AP002
Study information
Scientific title
A longitudinal changes of cardiac function with icodextrin in automated peritoneal dialysis patients
Acronym
Study hypothesis
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
The study protocol was approved by the Committee on Human Research at Kaohsiung Chang Gung Memorial Hospital (98-0390B)(March,2009)
Study design
Single-center randomized case-control trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Drug names
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 trial start date
01/03/2009
Overall trial end date
31/12/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Agreed to receive nocturnal APD regimen with daytime dwell of at least 10 h
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Total final enrolment
43
Participant 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.
Recruitment start date
31/03/2009
Recruitment end date
31/12/2010
Locations
Countries of recruitment
Taiwan
Trial participating centre
Kaohsiung Chang Gung Memorial hospital
123 Da Pei Rd, Niao Song Dist
Kaohsiung
833
Taiwan
Sponsor information
Organisation
Baxter
Sponsor details
not available in website
not available in website
not available in website
United States of America
Sponsor type
Industry
Website
Funders
Funder type
Not defined
Funder name
Baxter-Clinical Evidence Council (CEC) Fund
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
IPD sharing statement
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.
Intention to publish date
31/12/2018
Participant level data
Available on request
Basic results (scientific)
Publication list
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29739354 [added 16/01/2019]