Based on the hypothesis that the strategy of using Closed-Blood Sampling Devices (CSBD, experimental group) compared to the usual practice (waste discard volume, control group), in critically ill adult patients, will decrease the amount of blood withdrawn for laboratory tests, we want to analyze the number of red blood cells (RBC) administered and arterial catheter-related adverse events (catheter-related bacteremia, catheter obstruction, CBSD malfunction, loss of arterial pressure waveform on the patient's bedside monitor) in both study groups, during ICU stay and up to a maximum of 21 days.
When a patient with an arterial catheter completes 24h of admission to the unit, with an expected catheter stay of more than 72 hours, inclusion in the study will be assessed. If the patient does not meet the non-inclusion or exclusion criteria and consents to participate in the study, he/she will be randomized to the CBSD-experimental group or waste discard volume- control group. If the patient belongs to the CBSD-experimental group, the CBSD will be placed in the arterial line at that moment. All extractions performed will be through the arterial catheter and using the CBSD. In the waste discard volume- control group, the arterial catheter will also be used for extractions but with the usual open extraction system of the ICU. To quantify the blood loss related to blood collection for laboratory tests, the volume of discharge (VD) used for each analysis through the arterial catheter will be recorded. In the CBSD-experimental group the VD for arterial catheter will be zero since CBSD will always be used. The laboratory tubes extracted in each analysis will also be recorded. Data on blood analysis, blood transfusion and adverse events related to the arterial catheter will be recorded daily during the ICU stay, up to day 21 maximum and/or day of ICU discharge and/or exitus. Patients discharged from ICU to hospitalization will be followed only during the first 48h to know if they have received red blood cell concentrates and with what previous Hemoglobine (Hb) and hematocrit (Hto). Catheter insertion and maintenance will be carried out in the same way in both groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
216
blood collection with Closed-Blood Sampling System (CBSD)
Blood collection without CBSD, usual practice, need to waste discard volume
Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain
COMPLETEDHospital Rey Juan Carlos
Madrid, Madrid, Spain
RECRUITINGHospital Virgen de la Macarena
Seville, Sevilla, Spain
RECRUITINGUnits of red blood cells transfusion
Number of red blood cells (RBC) units administered in both study groups
Time frame: Every day during the ICU stay and up to a maximum of 21 days after randomization (day 0)
Volume of blood drawn
Volume of blood drawn in mL for laboratory testing in both study groups
Time frame: Every day during ICU stay and up to a maximum of 21 days after randomization (day 0).
Levels of hemoglobine and hematocrit
Hemoglobin (Hb) in g/dL and hematocrit (%) in both study groups
Time frame: Every day during ICU stay and up to a maximum of 21 days after randomization (day 0).
Number and type of adverse events
Arterial catheter-related adverse events in both groups (infection and/or catheter obstruction; lose of arterial pressure monitoring)
Time frame: Every day during the stay and up to a maximum of 21 days after randomization (day 0):
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