Assessment of Oxygen Extraction Rate Changes Following Red Blood Cell Transfusion in the Intensive Care Unit: a Prospective Observational Non-interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Percentage change in oxygen extraction rate
研究概览
简要总结
Restrictive and liberal approaches to hemoglobin targets are used when deciding on red blood cell transfusions in patients who do not have acute bleeding and have a hemodynamically stable course in the intensive care unit. However, physiologic trigger points that assess tissue oxygenation when deciding on blood transfusion in patients are also among the important topics of study in recent years. In this study, the investigators will evaluate the oxygen extraction rate, which is an important indicator of the balance between tissue oxygen delivery and consumption. Whether oxygen extraction rate can be used as a trigger for blood transfusion will be determined by clinical outcomes in ICU patients. If physiologic transfusion targets are feasible, the risks of unnecessary transfusions can be avoided with individualized targets, and the decision to transfuse blood can be made without delay in patients requiring red blood cell transfusion.
详细描述
This study will be prospective and observational in the Intensive Care Unit of Izmir Katip Celebi University Atatürk Training and Research Hospital. The study will not include any intervention and intervention groups. The study will enroll patients who have no acute bleeding, are hemodynamically stable, have been followed in the ICU for at least 24 hours, have a central venous catheter, and for whom the decision to transfuse red blood cells has been made according to the critical care protocol. Informed consent is obtained from the patient or first-degree relatives.
No additional procedures will be performed on patients during the study, and the decision to transfuse will not be influenced by the results of the examinations. For patients in whom the decision to transfuse red blood cells was made in accordance with the critical care protocol, the clinical decision and policy to transfuse a single unit and, accordingly, a restrictive transfusion strategy with a target hemoglobin of 7 g/dl are applied.
The patient's oxygen extraction rate is calculated using the following formula by considering the difference between the oxygen content of the venous and arterial blood gasses measured before transfusion.
CaO2 = SaO2 x Hb x 1.39 + (PaO2 x 0.0031) CcvO2 = ScvO2 x Hb x 1.39 + (PcvO2 x 0.0031) O2ER = CaO2 - CcvO2/CaO2
Patients to be followed until day 90 post-transfusion will be evaluated in two separate groups according to oxygen extraction rate < 30% and ≥30% after pretransfusion blood gas analysis. The primary objective of the study is to evaluate the percentage change in oxygen extraction rate after transfusion between the two groups with oxygen extraction rates of < 30% and ≥30%. The secondary objective is to examine the difference between the groups in 28-day mortality, near-infrared spectroscopy (NIRS) values related to tissue oxygenation, amount of blood products consumed, and length of ICU stay, as well as complication rates such as acute renal failure and acute lung injury.
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
- •Patients over 18 years old
- •Patients followed in the intensive care unit for at least 24 hours
- •Patients with central venous catheters
- •Patients who have received a decision to transfuse red blood cells
排除标准
- •Patients with hemodynamically unstable
- •Patients with acute bleeding
- •Patients in hemorrhagic shock
- •Patients with acute traumatic brain injury
- •Pregnant patients
结局指标
主要结局
Percentage change in oxygen extraction rate
时间窗: After transfusion of 15.minutes
Evaluate the percentage change in oxygen extraction rate after and before red blood cell transfusion between the two groups with oxygen extraction rates of \> 30% and ≥30%.
次要结局
- 7, 28 and 90 days mortality(7, 28 and 90 days)
- Near infrared spectroscopy values change(After transfusion of 15.minutes)
- Length of ICU stay(up to 90 days)
- Complication rates(up to 90 days)
- Number of mechanical ventilation dependent days(up to 90 days)
- Length of hospital stay(up to 90 days)
研究者
Ahmet Salih Tüzen, MD
Medical Doctor
Izmir Katip Celebi University