Oxygen Extraction-guided Transfusion

Università degli Studi di Ferrara324 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

324

Conditions

Blood Transfusion

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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). Exclusion Criteria: * 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

Locations (4)

Hospital Erasme

Brussels, Belgium

RECRUITING

Università di Ferrara

Ferrara, Ferrara, Italy

RECRUITING

Università di Perugia

Perugia, Italy, Italy

RECRUITING

Anestesia e Rianimazione Cardio-Toraco-Vascolare

Siena, Italy

RECRUITING

Outcomes

Primary Outcomes

Acute Kidney Injury (AKI)

Primary outcome will be the incidence of AKI, according to KDIGO latest definitions

Time frame: 7-day after study inclusion

Secondary Outcomes

90-day mortality

Time frame: 90-day after study inclusion

proportion of patients undergoing RBCT, despite adequate/low O2ER

Patients receiving RBCT with O2ER\<30%

Time frame: 28 days

SOFA score variations

SOFA score at study inclusion-SOFA score at day 5

Time frame: 5 days

variations in myocardial-specific troponin

Time frame: 24 hours after study inclusion

days on vasopressors

number of days on vasopressor therapy

Time frame: 28 days

Major Adverse Kidney Events by 90 days (MAKE90)

composite of death, new renal replacement therapy, or persistent renal dysfunction

Time frame: 90 days

ICU mortality

Time frame: through study completion, an average of 180 days

In-hospital mortality

Time frame: through study completion, an average of 180 days