Effectiveness and Safety of Icodextrin Peritoneal Dialysis Solution (Extraneal®) for Long Dwell Exchange in Peritoneal Dialysis in Patients With Chronic Renal Failure: a Multicenter, Ambispective Cohort, Observational, Real-world Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 439
- 试验地点
- 13
- 主要终点
- Comparison of the incidence of a composite endpoint for technique failure and death
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •Exclusion Criteria for the Glucose Group:
- •Those with combined HD within 30 days prior to baseline;
- •History of peritonitis within 30 days prior to baseline or presence of acute or chronic exit site infection or tunnel infection during baseline;
- •Prescription of non-Baxter PD solutions within 1 month prior to baseline.
- •Patients enrolled in the ICO group.
研究组 & 干预措施
Icodextrin (ICO) Group
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.
干预措施: Icodextrin Peritoneal Dialysis Solution (Drug)
Glucose Group
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.
干预措施: Glucose Peritoneal Dialysis Solution (Drug)
结局指标
主要结局
Comparison of the incidence of a composite endpoint for technique failure and death
时间窗: 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
次要结局
- Comparison of the proportion of patients with technique failure(12 months)
- Comparison of annual exchange dosage of ICO(12 months)
- Comparison of the incidence of the changes in ejection fraction(12 months)
- Comparison of all-cause deaths(12 months)
- Comparison of the incidence of cardiovascular events(12 months)
- Comparison of medical resource utilization in terms of hospitalizations(12 months)