Condition category
Urological and Genital Diseases
Date applied
23/03/2018
Date assigned
30/04/2018
Last edited
30/04/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

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

baxter.com

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

Intention to publish date

31/12/2018

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes