Insufficient Cellular Oxygen in ICU Patients With Anaemia: the INOX ICU-2 Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 103
- 试验地点
- 2
- 主要终点
- Variability of mitoPO2
研究概览
简要总结
The purpose of this study is whether the mitochondrial oxygenation tension (mitoPO2) is a feasible and reliable tool in ICU patients with anaemia undergoing red cell transfusion to ultimately personalize blood transfusion decisions in the ICU.
详细描述
Evidence is increasing that in some cases a Hb trigger of 7-8g/dl may be too low and te question arises whether an individualized red cell transfusion strategy may benefit critically ill patients. New studies have shown the potential of protoporphyrin IX-triple state lifetime technique to measure mitochondrial oxygenation tension (mitoPO2) in vivo, which possibly is an early indicator of oxygen disturbance in the cell and therefore a physiological trigger for red cell transfusion. The goals are: 1. Determining the feasibility of using mitoPO2 and the variability of mitoPO2 measurements in critically ill intensive care unit (ICU) patients before and after receiving a red cell transfusion 2. Describing the effects of red cell transfusion and the associated change in [Hb] on mitoPO2 and on other physiologic measures of tissue oxygenation and oxygen balance 3. Describing the association between mitoPO2 and vital organ functions. Included patients will undergo red cell transfusion as planned. However, red cell transfusion will be delayed by 2 hours. At multiple predefined moments data collection including blood samples and measurements of mitoPO2 will take place.
The results of this study cannot be immediately translated to clinical practice. Using these results, the investigators will design a phase 2 diagnostic study, most probably a randomized clinical trial that will yield applied knowledge with respect to personalizing red cell transfusion. Application will be in ICU patients with anaemia who might or might not profit from red cell transfusions. It will lead to a reduction of both over- and under- transfusion.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patient admitted to the ICU
- •Hb below 6.3 mmol/l (10 g/dl)
- •central venous catheter in situ
- •red cell transfusion planned
排除标准
- •adults without a legal representative to ask for informed consent
- •patients less than 18 years old
- •pregnant or breast feeding women
- •patients in need of emergency red cell transfusion e.g. bleeding
- •not having a central venous catheter in situ
- •porphyria and or known photodermatosis
- •patients with an expected ICU stay <24 hours
- •patients with hypersensitivity to the active substance or to the plaster material of ALA
结局指标
主要结局
Variability of mitoPO2
时间窗: Variability of mitoPO2 will be assessed during 8 predefined moments (within a timeframe of 24 hours) in the study
Variability of mitoPO2 before and after red cell transfusion. This will be compared to traditional parameters used to measure oxygenation and oxygen balance.
次要结局
- Organ damage(Value of mitoPO2 in predicting (ischemic) organ damage will be assessed during 8 predefined moments (within a timeframe of 24 hours) in the study)
- Microcirculation(Association of the mitoPO2 with the microcirculation will be assessed during 2 predefined moments (before transfusion and 24 hours after transfusion) in the study)
- Length of stay(Length of stay will be assessed during the 3 months follow-up time)
- Mortality(Mortality will be assessed during the 3 months follow-up time)
- Adverse events(Association of the mitoPO2 with adverse events will be assessed during 8 predefined moments (within a timeframe of 24 hours) in the study)