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Feasibility study of the inclusion of automated peritoneal dialysis and icodextrin solution for fluid overload adult chronic ESKD patients in the National Health Security System of Thailand

Automated peritoneal dialysis, icodextrin, continuous ambulatory peritoneal dialysis, Multi-centered, open-labeled randomized controlled trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20201215007
Enrollment
180
Registered
2020-12-15
Start date
2020-09-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End&#45

Interventions

The volunteers continue receiving the same continuous ambulatory peritoneal dialysis (CAPD) treatment using dextrose solution.,The volunteers receive CAPD treatment with 1 bag of Icodextrin per day an
Active Comparator Drug,Active Comparator Drug,Active Comparator Device
CAPD,CAPD with Icodextrin,APD

Sponsors

Health Systems Research Institute
Lead Sponsor
์None
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Universal coverage end stage renal disease patients treated with CAPD more than 3 months in hospital centers throughout Thailand in the North, Northern, Central and Southern regions 2) Patients who older than or equal to 18 years of age. 3) Patients who were treated with 2 liters of peritoneal dialysis fluid for 3-5 cycles per day. 4) Patients who were received at least 2 cycles of 2.5% Dextrose (D) dialysis fluid per day or 4.25% Dextrose (D) at least 1 cycle per day and still experienced one of the following symptoms. 4.1) Edema from excess water and salt 4.2) Poor blood pressure control defined by systolic blood pressure >= 140 or diastolic blood pressure >= 90 mm Hg. 4.3) Patients with symptoms of congestive heart failure within the past 1 year 5) Able to communicate in Thai in order to answer the Quality of Life Questionnaire

Exclusion criteria

Exclusion criteria: 1) Edema patients with the following reasons 1.1) very poor outflow of peritoneal drainage confirmed by ultrafiltration < &#45;200 ml defined by rapid flushing test of 2 L peritoneal dialysis solution. 1.2) edema from drug&#44; hypothyroidism&#44; cirrhosis or serum albumin&#44; 2g/dl 2) Patients with peritonitis within the past 1 month 3) Patients with systolic blood pressure <100 mm Hg. 4) Patients who&#44; having sepsis&#44; acute coronary syndrome&#44; congestive heart failure or acute stroke within 1 month at enrollment period 5) Patients who previously received icodextrin or received home APD 6) Pregnant women 7) Patients with end&#45;stage cancer or who are expected to live not more than 6 months. 8) Patients who will change to other treatment coverages wihin 1 year

Design outcomes

Primary

MeasureTime frame
The utility costs and budget impact 48 weeks Quality&#45;adjusted life year and Incremental Cost&#45;Effectiveness R,The social impact on all stakeholders and problems in all peritoneal dialysis modalities 48 weeks Semi&#45;Structured Questionnaires&#44; group disscussion&#44; deep interviews

Secondary

MeasureTime frame
clinical outcome 48 weeks patient survival&#44; Technique survival&#44; hospitalization&#44; peritonitis rate,Quality of life 48 weeks EQ5D5L

Countries

Thailand

Contacts

Public ContactPiyatida Chuengsaman

Ban Phaeo&#45;Charoen Krung Hospital Hemodialysis Center (Public Organization)

pjeungsmarn@yahoo.com081-593-9091

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026