Observational Study of the Use of Extraneal in Peritoneal Dialysis in Patients
- Conditions
- Chronic Renal Failure
- Interventions
- Drug: Glucose Peritoneal Dialysis Solution
- Registration Number
- NCT06492031
- Lead Sponsor
- Vantive Health LLC
- 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. Retrospective data will be collected up to 12 months from baseline (i.e., the most recent medical record before the index date, whereby the index date is defined as the date of the first prescription of glucose PD solutions for long dwell exchange between July 1, 2020, and December 31, 2020).
The effectiveness and safety between the 2 groups will be analyzed.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 889
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Icodextrin (ICO) Group Icodextrin Peritoneal Dialysis Solution Icodextrin is only intended for intraperitoneal administration and is recommended for long dwell during CAPD (i.e., recommended dwell time from 8-16 hours). Administration will be done at a rate that is comfortable for the patient, typically within 10-20 minutes. Glucose Group Glucose Peritoneal Dialysis Solution During CAPD, 2L of dialysis fluid is instilled into the peritoneal cavity and allowed to dwell for a certain period. The dwell time typically ranges from 4 to 8 hours during the day and 8 to 12 hours at night. This process is repeated 3 to 4 times a day, for 6 to 7 days a week. The frequency of solution exchanges may vary for each individual to achieve desired biochemical and solution control. Most solution exchanges utilize a 1.5% or 2.5% glucose dialysis solution. If more solution removal is required, a 4.25% glucose peritoneal dialysis solution can be used. Regular measurement of the patient's weight can be used to guide the setting of ultrafiltration volume.
- Primary Outcome Measures
Name Time Method 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 defines as adding HD treatment at least once every 2 weeks in 30 days during PD,
Death is specified as deaths during PD or deaths within 30 days with treatment from PD to HD/PHD
- Secondary Outcome Measures
Name Time Method Comparison of the proportion of patients with technique failure 12 months Number and proportion of patients with technique failure
Comparison of annual exchange dosage of ICO 12 months For ICO group only
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 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 medical resource utilization in terms of hospitalizations 12 months Excluding hospitalizations due to medicare payments or other non-medical issues. For ICO group only
Trial Locations
- Locations (10)
Beijing Haidian Hospital
🇨🇳Beijing, China
Hangzhou Hospital Of Traditional Chinese Medicine
🇨🇳Hangzhou, China
The Affiliated Hospital of Inner Mongolia Medical University
🇨🇳Hohhot, China
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