Monitoring Organ Donors to Increase Transplantation Results
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 556
- 试验地点
- 16
- 主要终点
- Number of organs transplanted.
研究概览
简要总结
The objective of this study is to determine whether protocol guided resuscitation of brain dead organ donors using Pulse Pressure Variation (PPV) will increase the number of organs transplanted per donor.
Specifically the study aims to:
- improve resuscitation of potential organ donors.
- improve organ function in donors.
- increase organ recovery per donor.
The investigators will randomize 960 subjects to either protocolized resuscitation (n=480) using a consensus-based PPV-guided algorithm or usual care using a 1:1 randomization scheme. The primary outcome is the mean number of organs transplanted per donor. Secondary outcomes include 6mHFS (six-month hospital-free survival) in the recipients, and mean number of organs procured per donor that are suitable for transplantation (intention to transplant). The study is powered to detect a 0.5 organ increase for transplantation per donor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Donors who were declared brain dead per local hospital brain death criteria.
- •Donors who are deemed suitable for organ donation by the local OPO whether they meet the standard criteria or the extended criteria for donation.
- •Presence of functioning arterial catheter.
- •Exclusion criteria:
- •Inability to obtain informed consent from donor next of kin or legal representative.
- •Donors less than 16 years of age, no maximum age limit.
- •Inability to perform hemodynamic monitoring.
- •Patients on lithium therapy prior to brain death.
- •Known severe aortic regurgitation, intra-cardiac shunts, or on intra-aortic balloon pump.
- •Donors previously enrolled in experimental protocol in which cytokines are the therapeutic targets (e.g. anti-TNF antibodies).
- •Donors receiving chemotherapy or with any disease state (e.g. AIDS) that renders the subject leukopenic (WBC count < 2).
- •Donors receiving anti-leukocyte drugs (e.g. OKT3) regardless of their WBC counts.
- •Pregnant donors.
- •Donor is on ECMO machine
排除标准
- 未提供
研究组 & 干预措施
Protocolized Care
Algorithm to manage Pulse Pressure Variation, Cardiac Index, and Mean Arterial Pressure will be used in these donors.
干预措施: Protocolized care (Procedure)
Standard Care
This is the Organ Procurement Organization current practices.
结局指标
主要结局
Number of organs transplanted.
时间窗: At explantation
次要结局
- Expected Observed Ratio(At Explantation)
- Organ Recipient six month hospital free survival(6 months post transplant)
- Number of organs that are transplantable.(At Explantation)
研究者
John Kellum
M.D.
University of Pittsburgh