Department of Intensive Care, LUMC, Leiden, The Netherlands.
Clinical Transfusion Research, Sanquin Research Clinical Transfusion Research, Leiden, Zuid-Holland, The Netherlands.
BMJ Open. 2020 May 17;10(5):e036351. doi: 10.1136/bmjopen-2019-036351.
The recently developed protoporphyrin IX-triple state lifetime technique measures mitochondrial oxygenation tension (mitoPO) in vivo at the bedside. MitoPOmight be an early indicator of oxygen disbalance in cells of critically ill patients and therefore may support clinical decisions regarding red blood cell (RBC) transfusion. We aim to investigate the effect of RBC transfusion and the associated changes in haemoglobin concentration on mitoPO and other physiological measures of tissue oxygenation and oxygen balance in critically ill patients with anaemia. We present the protocol and pilot results for this study.
We perform a prospective multicentre observational study in three mixed intensive care units in the Netherlands with critically ill patients with anaemia in whom an RBC transfusion is planned. The skin of the anterior chest wall of the patients is primed with a 5-aminolevulinic acid patch for 4 hours for induction of mitochondrial protoporphyrin-IX to enable measurements of mitoPO, which is done with the COMET monitoring device. At multiple predefined moments, before and after RBC transfusion, we assess mitoPO and other physiological parameters of oxygen balance and tissue oxygenation. Descriptive statistics will be used to describe the data. A linear mixed-effect model will be used to study the association between RBC transfusion and mitoPO and other traditional parameters of oxygenation, oxygen delivery and oxygen balance. Missing data will be imputed using multiple imputation methods.
The institutional ethics committee of each participating centre approved the study (reference P16.303), which will be conducted according to the 1964 Helsinki declaration and its later amendments. The results will be submitted for publication in peer-reviewed journals and presented at scientific conferences.
NCT03092297.
最近开发的原卟啉 IX 三重态寿命技术可在床边对体内的线粒体氧张力（mitoPO）进行测量。mitoPO 可能是危重病患者细胞中氧失衡的早期指标，因此可能支持关于红细胞（RBC）输血的临床决策。我们旨在研究 RBC 输血及其相关的血红蛋白浓度变化对 mitoPO 以及其他组织氧合和氧平衡的生理指标的影响在患有贫血的危重病患者中。我们提出了该研究的方案和初步结果。
我们在荷兰的三个混合重症监护病房进行了一项前瞻性多中心观察性研究，研究对象为计划进行 RBC 输血的贫血危重病患者。患者前胸壁的皮肤用 5-氨基酮戊酸贴片预处理 4 小时，以诱导线粒体原卟啉-IX 的产生，从而使用 COMET 监测设备测量 mitoPO。在 RBC 输血前和输血后的多个预定时刻，我们评估 mitoPO 和其他氧平衡和组织氧合的生理参数。将使用描述性统计来描述数据。线性混合效应模型将用于研究 RBC 输血与 mitoPO 以及其他传统的氧合、氧输送和氧平衡参数之间的关联。使用多种插补方法对缺失数据进行插补。
每个参与中心的机构伦理委员会都批准了这项研究（参考 P16.303），该研究将根据 1964 年的赫尔辛基宣言及其后来的修正案进行。研究结果将提交给同行评议的期刊发表，并在科学会议上展示。
NCT03092297。
