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.
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.
Study Type
OBSERVATIONAL
Enrollment
439
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.
Beijing Haidian Hospital
Beijing, China
Hangzhou Hospital Of Traditional Chinese Medicine
Hangzhou, China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, China
Comparison of the incidence of a composite endpoint for technique failure and death
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
Time frame: 12 months
Comparison of the proportion of patients with technique failure
Number and proportion of patients with technique failure
Time frame: 12 months
Comparison of the incidence of cardiovascular events
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.
Time frame: 12 months
Comparison of the incidence of the changes in ejection fraction
Change of the echocardiographic values from baseline: left ventricular ejection fraction fraction (LVEF)
Time frame: 12 months
Comparison of all-cause deaths
All-cause deaths refer to the total number of deaths from any cause within the study timeframe
Time frame: 12 months
Comparison of medical resource utilization in terms of hospitalizations
Excluding hospitalizations due to medicare payments or other non-medical issues. For ICO group only
Time frame: 12 months
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Nanjing Drum Tower Hospital
Jiangse, China
Wuxi People's Hospital
Jiangse, China
The First People's Hospital of Kunshan
Jiangse, China
Ningbo First Hospital
Ningbo, China
Shanghai General Hospital
Shanghai, China
Renji Hospital Shanghai Jaotong University School of Medicine
Shanghai, China
The Second Affiliated Hospital of Soochow University
Suzhou, China
Comparison of annual exchange dosage of ICO
For ICO group only
Time frame: 12 months