Oxygen Extraction-guided Transfusion Strategy in Critically Ill Patients. A Randomized Controlled Trial.
概览
- 阶段
- 不适用
- 干预措施
- Individualized red blood cell transfusion strategy
- 疾病 / 适应症
- Blood Transfusion
- 发起方
- Università degli Studi di Ferrara
- 入组人数
- 324
- 试验地点
- 7
- 主要终点
- Acute Kidney Injury (AKI)
- 状态
- 招募中
- 最后更新
- 昨天
概览
简要总结
In critically ill patients, optimized strategies for red blood cells transfusion (RBCT) are still controversial. Most recent guidelines suggest that clinical practice in ICU setting should follow a restrictive approach to RBCT (i.e., hemoglonim level < 7.0 g/dL).In our previous study, oxygen extraction ratio (O2ER) has shown good performance as a marker to identify the correct timing for RBCT, potentially affecting 90-day mortality in non-bleeding, critically ill patients [11]. Moreover, our data suggested that an individualized strategy for RBCT may reduce the incidence of acute kidney injury (AKI), which is possibly related to a better delivery of oxygen and organ perfusion.
研究者
Alberto Fogagnolo
Dr
Università degli Studi di Ferrara
入排标准
入选标准
- •Hb levels ≤ 9.0 g/dL (as confirmed through a blood test and/or through blood gas analysis)
- •Presence of an arterial line and a central venous line (either jugular or subclavian), with confirmed correct position of the catheter tip at the atrio-caval junction (allowing correct estimation of central venous saturation, ScvO2).
排除标准
- •Age \< 18 years;
- •Pregnancy
- •Clinical evidence of acute bleeding
- •Diagnosis of haematological malignancy
- •Diagnosis of sickle cell disease, or other diseases exposing the patient to chronic RCBTs
- •Acquired or congenital disorders of coagulation
- •Patients with ongoing AKI of stage 1 or worse and/or known chronic kidney disease (CKD) of stage G3a or worse, defined as glomerular filtration rate below 60 for a minimum of 3 months
研究组 & 干预措施
Individualized RBCT
Requires daily assessment of hemoglobin (Hb) levels. Prescription of RCBT is restricted to patients who present Hb ≤ 9.0 g/dL and O2ER ≥ 30%. If O2ER \< 30%, transfusion will take place only when Hb falls below 7.0 g/dL. Further O2ER measurements during the day in this group are allowed, and the clinician should not be blinded of the results. To tolerate Hb levels below 7.0 g/dL with O2ER \< 30% remains a clinical decision, documented in the CRF. Transfusion with Hb below 6.0 g/dL is mandatory
干预措施: Individualized red blood cell transfusion strategy
Control group
Requires daily assessment of hemoglobin levels. Prescription of RCBT is restricted to patients who present Hb ≤ 7.0 g/dL, despite of O2ER values. Indeed, O2ER calculation takes place at least once daily in this group but does not interfere with clinical decision to prescribe RBCT. A liberal transfusion threshold (i.e. 9.0 g/dL) is still possible in critically ill adults with acute coronary syndromes, as indicated by the European current guidelines
干预措施: European guidelines red blood cell transfusion strategy
结局指标
主要结局
Acute Kidney Injury (AKI)
时间窗: 7-day after study inclusion
Primary outcome will be the incidence of AKI, according to KDIGO latest definitions
次要结局
- days on vasopressors(28 days)
- In-hospital mortality(through study completion, an average of 180 days)
- variations in myocardial-specific troponin(24 hours after study inclusion)
- proportion of patients undergoing RBCT, despite adequate/low O2ER(28 days)
- SOFA score variations(5 days)
- Major Adverse Kidney Events by 90 days (MAKE90)(90 days)
- ICU mortality(through study completion, an average of 180 days)
- 90-day mortality(90-day after study inclusion)