ULTRA-Peds: A Multicenter Data Registry for Outcomes for Pediatric Volume Overload
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 97
- 试验地点
- 7
- 主要终点
- Change % fluid overload during treatment course
研究概览
简要总结
The ULTRA-Peds registry will employ a multi-center, single-arm, open-label, observational design to capture baseline, procedural and follow-up data on pediatric patients that have been treated (i.e., retrospective data from treatment at the time of registry approval by the IRB) or are scheduled to be treated (i.e., prospective data for on-label treatment after registry approval by the IRB) with Aquadex therapy according to local standard of care practices and decisions. All prospective data will be from on-label Aquadex treatment of pediatric patients weighing 20 kilograms or more. No data from prospective off-label treatment (i.e., Aquadex treatment with other adjunctive or conjunctive therapies for pediatric patients who may weigh less than 20kg) will be included in the registry. An estimated 10 sites in the United States who have received training in extracorporeal therapy and the Aquadex™ system will enroll a minimum of 500 patients.
详细描述
The ULTRA-PEDs registry is designed to capture data in the real-World clinical setting on the Aquadex™ system in local standard of care, with the aim of understanding it's performance and utilization. Enrollment is expected to take approximately 2.5 years from the time the first patient is enrolled to the time the final patient is discharged from the hospital.
ULTRA-PEDs will allow prospective and retrospective data collection for the following scenarios:
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All prospective data for on-label use only (i.e., Aquadex ultrafiltration therapy for pediatric patients weighing 20 kg or more, whose fluid overload is unresponsive to medical management, including diuretics).
-
Retrospective patients at the time of registry approval by IRB regardless of on-label or off-label use.
-
Retrospective on-label use
-
Retrospective off-label use (i.e., Aquadex ultrafiltration with other adjunctive or conjunctive therapies for pediatric patients who may weigh less than 20kg)
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
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •I. For enrollment in prospective data collection:
- •Patient age is 21 years or younger
- •Patient weighs 20 kilograms or more.
- •Patient or legally authorized representative provides written authorization or patient is hospitalized and receiving treatment in a center with an Institutional Review Board that has allowed for waived consent based on the type of data being collected for the Registry.
- •Patient is to undergo Aquadex therapy for fluid overload (i.e., fluid removal) as local standard of care.
- •II. For enrollment in retrospective data collection:
- •Patient age is 21 years or younger.
- •Patient or legally authorized representative provides written authorization or patient is hospitalized and receiving treatment in a center with an Institutional Review Board that has allowed for waived consent based on the type of data being collected for the Registry.
- •Patient underwent Aquadex therapy for fluid overload (i.e., fluid removal) as local standard of care.
排除标准
- •Unable or unwilling to provide informed consent
- •Unable or unwilling to comply with study requirements
结局指标
主要结局
Change % fluid overload during treatment course
时间窗: Through completion of a treatment course, up to 3 months
% change in weight from initiation to the end of the last Aquadex procedure
Aquadex related adverse events
时间窗: Through completion of a treatment course, up to 3 months
Aquadex related adverse events
Treatment Survival
时间窗: Through completion of a treatment course, up to 3 months
Patient survive treatment course
Hemodynamic stability at initiation of UF therapy
时间窗: From the time of index procedure is initiated up to 60 minutes after initiation
Need resuscitation fluids and medications (e.g. vasoactive medication)
Change in PRISM III Score
时间窗: 2 hours before ICU admission through the first 4 hours after ICU discharge
Physiologic variables and labs to assess mortality risk
Survival at ICU discharge
时间窗: Through completion of a treatment course in the ICU, up to 1 month
% of ICU patients survive treatment in ICU
Change in Kidney Function
时间窗: Change eGFR and renal labs from initiation to completion of treatment, up to 3 months
Assessment of Kidney function
Hemodynamic stability during treatment course
时间窗: Through completion of a treatment course, up to 3 months
Need for vasoactive medication
Length of Stay in ICU
时间窗: The time from admission to ICU through discharge from ICU, usually 1 month
Time of admission to ICU to discharge
次要结局
未报告次要终点