Observational Study of the Use of Extraneal in Peritoneal Dialysis in Patients (NCT06492031) | Clinical Trial Compass
CompletedNot Applicable
Observational Study of the Use of Extraneal in Peritoneal Dialysis in Patients
China439 participantsStarted 2024-06-28
Plain-language summary
The purpose of this study is to evaluate the effectiveness and safety of icodextrin and glucose peritoneal dialysis (PD) solutions for the long dwell exchange in PD patients with continuous ambulatory peritoneal dialysis (CAPD), and to describe medical resource utilization in patients with PD on icodextrin.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria for patients enrolled retrospectively in the ICO Group:
* Age ≥ 18 years old at first prescription of icodextrin, male or female;
* With a definite diagnosis of CRF and on maintenance PD ≥ 3 months;
* On CAPD treatment;
* Being treated with icodextrin long dwell exchange with an icodextrin prescription ≤ 6 months with essential baseline information(including age, gender, PD vintage, presence of diabetes or not, PET, and assessment of dialysis adequacy);
* Voluntarily sign the informed consent form (ICF) and be willing to complete the study visits as required by the investigator (For death cases, exemption of the informed consent will be applied with approval of the ethics committee).
Inclusion Criteria for patients enrolled prospectively in the ICO Group:
* Age ≥ 18 years old, male or female;
* Patients with a definite diagnosis of CRF and on maintenance PD ≥ 3 months;
* On CAPD treatment, with planned prescription for icodextrin;
* Voluntarily sign the ICF and be willing to complete the study visits as required by the investigator.
Exclusion Criteria for the ICO Group:
* Those with combined HD within 30 days prior to enrolment;
* History of peritonitis within 30 days prior to enrolment or presence of acute or chronic exit site infection or tunnel infection at enrolment;
* Participation in another interventional study within 30 days prior to enrolment or concurrently with this study;
* Allergy to any components of Icodextrin;
* Pregnancy or in lactatio…
What they're measuring
1
Comparison of the incidence of a composite endpoint for technique failure and death