Septic Patients
Conditions
Brief summary
Aim of the study is to evaluate the effects, on microcirculation of septic patient, of three types of RBCs: 1- fresh standard RBCs (storage \<10 days); 2-leukodepleted RBCs and 3-old standard RBCs (storage \>15 days) respectively. Before and 1 hour after the transfusion, microcirculation is evaluated using Sidestream Dark Field Imaging (SDF) and Near InfraRed Spectroscopy (NIRS) with vascular occlusion test. We also monitor temperature, heart rate, mean blood pressure, hemochrome, blood gases, blood lactates and SOFA score.
Interventions
BIOLOGICALBlood transfusion
RBCs have been transfused in septic patient admitted in ICU
Sponsors
Azienda Ospedaliero, Universitaria Ospedali Riuniti
Università Politecnica delle Marche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with sepsis, severe sepsis or septic shock who, according to clinical evaluation, need a hemotransfusion.
Exclusion criteria
* Patients under 18 years of age; Pregnancy; Coagulative disorders; Cardiogenic shock (Met\<4;)Acute massive bleeding (\>8 U)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microcirculatory Flow Index (MFI) before and after blood transfusion. | One hour after the end of blood transfusion compared with before blood transfusion | Microcirculatory Flow Index detected in vivo by side-dark field imaging at sublingual microcirculation. It represents the quality of blood flow at microcirculatory level. This study wants to verify any of the considered different types of blood transfused can improve MFI. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perfused Vessel Density (PVD) | One hour after the end of blood transfusion compared with before blood transfusion | Perfused Vessel Density detected in vivo by side-dark field imaging at sublingual microcirculation. It represents the quantity of well perfused vessels at microcirculatory level. This study wants to verify any of the considered different types of blood transfused can improve PVD. |
| StO2 upslope | One hour after the end of blood transfusion compared with before blood transfusion | StO2 upslope is measured with Near InfraRed Spectroscopy at the tenar muscle. It represents the velocity of the recovery of the tissue oxygen saturation after a short period of ischemia of the hand, the Vascular Occlusion Test. |
| Arterial Blood Lactate | One hour after the end of blood transfusion compared with before blood transfusion | — |
| Arterial pH | One hour after the end of blood transfusion compared with before blood transfusion | — |
| SOFA score | One hour after the end of blood transfusion compared with before blood transfusion | — |
Countries
Italy
Outcome results
None listed