Insufficient Oxygenation in Septic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Change of mitoPO2 during first 24 hours of a septic patient
研究概览
简要总结
This study will describe the change of mitochondrial oxygen tension (mitoPO2) compared to traditional parameters of oxygenation and oxygen balance in the first 24 hours of septic patients admitted to the intensive care unit of an academic hospital. The mitoPO2 will be measured on prespecified measurement moments in the ICU. With each measurement moment, arterial and central venous blood gasses will be taken too.
详细描述
Evidence is increasing that there is no clear parameter for tissue oxygenation in critically ill septic patients to guide resuscitation. 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 disbalance in the cell and therefore a physiological trigger for fluid therapy.
Objectives: 1. To describe mitoPO2 measurements in patients with sepsis who are about to receive fluid therapy 2. To describe the effects of fluid therapy and the associated change in mitoPO2 and change in other physiologic measures of tissue oxygenation and oxygen balance 3.To describe the association between mitoPO2 and vital organ (dis)functions and change of SOFA (Sequential organ failure assessment) score after 24hrs 5. To describe the microcirculatory, cellular and mitochondrial function during the first 24 hours of septic patients.
Study population: critically ill patients with sepsis which are admitted to the intensive care unit through the emergency department or hospital ward and in whom fluid therapy (crystalloid, albumin and red cell transfusion) is planned.
Main study endpoints
Primary endpoint: Change in mitoPO2 after fluid therapy. This will be compared to traditional parameters used to measure oxygenation and oxygen balance
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
- •Age of patient is at least 18 years
- •Patients diagnosed with sepsis in the emergency department or hospital ward
- •Patients are admitted to the ICU via the hospital ward or emergency department
- •Informed consent is given either by the patient or if the patient is too ill to give informed consent, by his or her legal representative.
- •Patients have an arterial catheter in situ, since blood samples will be taken for the study. Most patients admitted to the ICU have an arterial catheter in place since it is part of standard care.
排除标准
- •Patients younger than 18 years
- •Patients with sepsis discharged after emergency department visit
- •Patients admitted to a hospital ward other than the ICU after emergency department visit
- •Patients who cannot give informed consent themselves and without a legal representative will be excluded since no informed consent can be obtained
- •Patients known with porphyria and/or photodermatosis will be excluded, since the risk of phototoxicity
- •Patients with hypersensitivity to the active substance or to the plaster material of ALA (5-aminolevulinic acid)
- •Pregnant or breast feeding women since there is no adequate data form the use of ALA in pregnant or breast feeding women
- •Insufficient comprehensibility of the Dutch language
结局指标
主要结局
Change of mitoPO2 during first 24 hours of a septic patient
时间窗: 24 hours
The primary endpoint is the change of mitoPO2(mitochondrial oxygenation) before and after fluid therapy in patients with sepsis. This will be compared to traditional parameters used to measure tissue oxygenation and oxygen balance (central venous oxygen saturation, mean arterial pressure and lactate).
次要结局
- Length of ICU stay(3 months)
- Length of hospital stay(3 months)
- In-hospital mortality(3 months)
- SOFA (sequential organ failure assessment) score after 24 hours(24 hours)
- ICU mortality(3 months)
- Organ (dis)function(24 hours)
- Validation of mitoPO2 measurement with blood based biomarkers of cellular function(24 hours)
- Safety (incidence of adverse and serious adverse events)(24 hours)
研究者
J.G. van der Bom
Manager clinical transfusion research
Leiden University Medical Center