Hyperoxia, Erythropoiesis and Tissue Oxygenation in Critically Ill Patient
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Effectiveness of Normobaric Oxygen Hyperoxia in increasing serum erythropoietin levels in critically ill patients
研究概览
简要总结
Prospective observational study in 40 adult critically ill patients. Patients were eligible if they were mechanically ventilated with an FiO2 ≤0.5 and PaO2/FiO2 ≥200 mmHg and hemodynamically stable with a hemoglobin ≥9 g/dL, no acute bleeding or need for blood transfusions, no renal failure, no chronic obstructive pulmonary disease. Twenty patients (hyperoxia group) underwent a 2-hour exposure to normobaric hyperoxia (FiO2 1.0), 20 patients were evaluated as controls. Serum erythropoietin (EPO) was measured at baseline, 24h and 48h. Serum Glutathione (GSH) and reacting oxygen species (ROS) were assessed at baseline (t0), after 2 hours of hyperoxia (t1) and 2 hours after the return to baseline FiO2 (t2). Sidestream dark field videomicroscopy was applied sublingually to assess the microvascular response to hyperoxia. Near infrared spectroscopy with a vascular occlusion test was applied at t0, t1, t2.
详细描述
Interventions:
Forty patients were enrolled in total. The first 20 patients (hyperoxia group) underwent a 2-hour period of normobaric hyperoxia (FiO2 1.0), according to the protocol applied in. No variation in the FiO2 was applied for the other 20 patients (control group). All patients were enrolled in the morning and hyperoxia was performed in the time range between 10am-2pm in order to minimize variability due to the circadian rhythm of EPO production. No variations to sedation or vasopressor dose were applied during the study period.
Measurements:
On the study day, measurements were taken at 2-hour intervals: baseline (t0), under 1.0 FiO2 (t1) and after returning to baseline FiO2 (t2). These included: body temperature, heart rate (HR), mean arterial pressure (MAP), arterial oxygen saturation (SaO2), arterial partial pressure of oxygen (PaO2) and carbon dioxide (PaCO2), PaO2/FiO2, arterial pH, bicarbonate, base excess) and central venous saturation (ScvO2) blood gases, arterial lactates, evaluation of the sublingual microcirculation and tissue oxygenation. The same measurements were performed in the control group at 2-hour intervals. In 24 patients (12 patients per group), arterial blood samples (10 mL) were taken at each time point and immediately centrifuged; plasma and serum were stored at -70°C for subsequent analyses. Serum EPO, reticulocyte count, hemoglobin (Hb) and hematocrit were measured at 8am in all patients on the study day, at 24 and 48 hours.
Microcirculation measurements with sidestream dark field imaging The sublingual microcirculation was evaluated with sidestream dark field (SDF) videomicroscopy (Microscan, Microvision Medical, Amsterdam, NL). This technique has been described in details elsewhere.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Mechanical Ventilated Patients
排除标准
- •PaO2/FiO2 < 200
- •hemoglobin (Hb) <9 g/dL
- •acute bleeding or blood transfusions during the study period
- •any surgical interventions during the study period
- •acute or chronic renal failure
- •hemodynamic instability
- •chronic obstructive pulmonary disease
- •pregnancy
- •factors impeding the sublingual microcirculation evaluation (oral surgery or facial trauma)
结局指标
主要结局
Effectiveness of Normobaric Oxygen Hyperoxia in increasing serum erythropoietin levels in critically ill patients
时间窗: up to 2 day after FiO2=1 exposure
Blood samples to detect erythropoietin
次要结局
- Hyperoxia and variations in circulating ROS(Before FiO2 = 1, after 2 hours of FiO2=1 exposure, 2 hours after the end of FiO2=1 exposure)
- Effectiveness of Normobaric Oxygen Hyperoxia in increasing serum erythropoietin levels in critically ill patients after 1 day(Before FIO2 = 1 and at 1 day after FiO2 = 1 exposure)
- Effects of hyperoxia on the sublingual microcirculation(Before FiO2, after 2 hours of FiO2=1 exposure, 2 hours after the end of FiO2=1 exposure)
- Effects of hyperoxia on the peripheral microcirculation(Before FiO2 = 1, after 2 hours of FiO2=1 exposure, 2 hours after the end of FiO2=1 exposure)
- Hyperoxia and variations in circulating nitric oxide(Before FiO2 = 1, after 2 hours of FiO2=1 exposure, 2 hours after the end of FiO2=1 exposure)
- Hyperoxia and variations in circulating glutathione(Before FiO2 = 1, after 2 hours of FiO2=1 exposure, 2 hours after the end of FiO2=1 exposure)
- Reticulocyte Count(Before FiO2 = 1, at 1 day and 2 day after FiO2=1 exposure)
研究者
Abele Donati, MD
Associate Professor and Medical Doctor
Università Politecnica delle Marche