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

Phase 3

Recruiting

• Conditions: End- icodextrin; stage kidney disease patients who have excess hydration and sodium in the body.; continuous ambulatory peritoneal dialysis; automated peritoneal dialysis; cost utility analysis; hypervolemia; hypertension; quality of life

• Registration Number: TCTR20201215007
• Lead Sponsor: Health Systems Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-15
• Study Completion: 2022-07-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 180

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

1) Edema patients with the following reasons
1.1) very poor outflow of peritoneal drainage confirmed by ultrafiltration < -200 ml defined by rapid flushing test of 2 L peritoneal dialysis solution.
1.2) edema from drug, hypothyroidism, cirrhosis or serum albumin, 2g/dl
2) Patients with peritonitis within the past 1 month
3) Patients with systolic blood pressure <100 mm Hg.
4) Patients who, having sepsis, acute coronary syndrome, 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-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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The utility costs and budget impact 48 weeks Quality-adjusted life year and Incremental Cost-Effectiveness R,The social impact on all stakeholders and problems in all peritoneal dialysis modalities 48 weeks Semi-Structured Questionnaires, group disscussion, deep interviews

Secondary Outcome Measures

Name	Time	Method
clinical outcome 48 weeks patient survival, Technique survival, hospitalization, peritonitis rate,Quality of life 48 weeks EQ5D5