Tissue Oxygen Saturation During Management of the Deceased by Neurological Criteria Organ Donor as a Predictor of Number of Organs to Transplant Per Donor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of organs transplanted per donor
研究概览
简要总结
The objective of this study is to quantify the association between tissue oxygen saturation (StO2) during the donor management phase of the Death by Neurological Criteria (DNC) organ donor and the number of organs transplanted per donor.
详细描述
Specifically the study aims to:
- Evaluate the association between StO2 level in the DNC organ donor and the number of organs transplanted per donor;
- Evaluate whether or not tissue perfusion in the DNC organ donor population correlates with currently measured macro-hemodynamic variables during the donor management phase.
- Assess if StO2 in the DNC organ donor is related to the number of organs with normal end-organ function, and with the number of organs predicted to be transplanted using the organ donor calculator.
- Assess if StO2 in the DNC organ donor is related with intravenous thyroid hormone treatment.
Investigators will conduct an observational study, including 60 DNC organ donors, in Lifebanc's Donor Service Area (DSA). Investigators will monitor and record blindly the StO2 with near-infrared spectroscopy (NIRS) in the DNC organ donor from the beginning of the OPO (Organ Procurement Organization) organ donor management period until cardiac arrest in the operating room at the time of recovery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DNC organ donor
- •Age ≥ 15 years old
- •Weight ≥ 45 Kg
排除标准
- •Donor after circulatory determination of death
- •Living donor
结局指标
主要结局
Number of organs transplanted per donor
时间窗: At 24 hours after transfering the donor to operating room.
次要结局
- Correlation of tissue oxygenation readings to macro-hemodynamic measurements(During donor management until cardiac arrest at the operating room)
- Variation of tissue oxygenation after thyroid hormone is initiated, titrated and/or discontinued.(During donor management until cardiac arrest at the operating room)
- Number of organs with targeted end-organ function per donor(At the last hour at the Intensive Care Unit, before the donor is transferred to the operating room.)
- Number of organs predicted to be transplanted using organ donor calculator(At the last hour at the Intensive Care Unit, before the donor is transferred to the operating room.)
研究者
Silvia Perez-Protto, MD
M.D.
The Cleveland Clinic