Cost utility analysis cost utility analysis peritoneal dialysis Homodimer Neutrophil Gelatinase-associated Lipocalin rapid point of care test POCT Home use
Conditions
Interventions
Experimental Device,No Intervention Other
Sponsors
Fresenius Medical Care Ltd
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: General 1. Minimum age of 18 years. 2. Existing informed consent form signed and dated by study patient as well as investigator/authorized physician. 3. Patient is legally competent and able to understand the nature, risks, meaning, and consequences of the clinical trial and can subsequently declare her/his consent for participation in the clinical trial. Study-specific 1. End-Stage Renal Disease (ESRD) patients under Peritoneal Dialysis (PD) (Continuous Ambulatory Peritoneal Dialysis (CAPD) or APD) treatment with minimum period of 90 days. 2. Subjects or caregivers are able to properly use H-NGAL POCT by following the Instructions for use (IFU) instruction.
Exclusion criteria
Exclusion criteria: General 1. Patient is not able to give informed consent or any condition which could interfere with the patient ability to comply with the study. This decision is at the discretion of the treating physician and relates to the general stable condition of the patient (e.g. any acute condition, e.g. infection or mental problem which might give reason for concern etc.) 2. Ongoing participation in an interventional clinical study within 30 days before randomization. 3. Previous participation in this study. Study specific 1. Presence of a peritonitis episode within 30 days before randomization. 2. Patient is under treatment with other blood purification modalities, e.g. HD, CRRT, etc. within 30 days before randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| cost utility analysis 3 months Incremental Cost-Effectiveness Ratio, One way Sensitivity Analysis, Probabilistic Sensitivity Analysis | — |
Secondary
| Measure | Time frame |
|---|---|
| Budget impact analysis 1 year payer perspective | — |
Countries
Thailand
Contacts
Public ContactSuchai Sritippayawan
Division of Nephrology, Department of Internal Medicine, Siriraj Hospital, Mahidol University
Outcome results
None listed