Chronic Renal Failure
Conditions
Keywords
Continuous ambulatory peritoneal dialysis
Brief 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.
Detailed description
Patients will be divided into icodextrin dialysate group (ICO group) and glucose dialysate group (glucose group). ICO group: Patient data will be collected retrospectively and prospectively. Patients currently prescribed icodextrin will be recruited and enrolled. Data for these patients will included both retrospective historical data collection as well as a prospective collection of additional data. Within the relative look-back period (i.e., within 6 months before the launch of the study site), data will be collected from baseline (i.e., the most recent medical records prior to the first prescription of icodextrin) up to signing of the ICF. After providing informed consent, patient data will be prospectively collected for 12 months. Additionally, any patients who are first prescribed icodextrin therapy after the launch of the study site will also be recruited and enrolled prospectively and data will be collected up to 12 months from enrollment for this group. For these patients, baseline will be defined as the most recent medical record from the time of signing the ICF to the first prescription of icodextrin. Glucose group: Patient data will be collected retrospectively from CAPD patients followed up in the peritoneal dialysis center from July 1, 2018, to December 31, 2018. Retrospective data will be collected up to 12 months from baseline (i.e., the most recent peritoneal equilibration test date before December 31, 2018, in the peritoneal dialysis center). The effectiveness and safety between the 2 groups will be analyzed.
Interventions
The treatment modality, treatment frequency, treatment dose, duration of dwell, and length of treatment, as determined and supervised by a prescribing physician experienced in treating ESRD with PD.
The treatment modality, number of daily dialysate exchanges, dialysate concentration, exchange dosage of dialysate, duration of dwell, and length of treatment for PD patients as determined by the clinician.
Sponsors
Vantive Health LLC
Baxter Healthcare Corporation
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 lactation; * Any other condition for which the investigator considers the patient to be unsuitable for participation in this study. Inclusion Criteria for the Glucose Group: * Age ≥ 18 years at baseline, male or female; * Those with a definitive diagnosis of CRF prior to baseline and eligible for CAPD treatment with Baxter's glucose PD solutions between July 1, 2018 and December 31, 2018; * On maintenance PD ≥ 3 months; * Essential baseline information (including age, gender, PD vintage, presence of diabetes or not, peritoneal transport status, dialysis adequacy assessment, 24-hour urine volume); * Any prescription of Baxter's glucose PD solutions and medical records of clinical events within 1 year from baseline.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the incidence of a composite endpoint for technique failure and death | 12 months | Technique failure is defined as: * Treatment transferred from PD to HD/PHD \> 30 days; or * PHD, defined as adding HD treatment at least once every 2 weeks in 30 days during PD and requiring long-term combined HD as determined by the investigator. Death is specified as deaths during PD or deaths within 30 days with treatment from PD to HD/PHD |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the proportion of patients with technique failure | 12 months | Number and proportion of patients with technique failure |
| Comparison of the incidence of cardiovascular events | 12 months | Cardiovascular events include acute myocardial infarction, sudden severe arrhythmia ( a trial fibrillation and arrhythmia requiring hospitalization or medication), hospitalization for heart failure, stroke, and cardiovascular death. |
| Comparison of the incidence of the changes in ejection fraction | 12 months | Change of the echocardiographic values from baseline: left ventricular ejection fraction fraction (LVEF） |
| Comparison of all-cause deaths | 12 months | All-cause deaths refer to the total number of deaths from any cause within the study timeframe |
| Comparison of medical resource utilization in terms of hospitalizations | 12 months | Excluding hospitalizations due to medicare payments or other non-medical issues. For ICO group only |
| Comparison of annual exchange dosage of ICO | 12 months | For ICO group only |
Countries
China
Outcome results
None listed