Effects on Septic Patient's Microcirculation of the Transfusion of Different Types of Concentrated RBCs.

Study Overview
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Brief Summary
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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.

Official Title
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Effects on the Septic Patient's Microcirculation of the Transfusion of Three Different Types of Concentrated Red Blood Cells.

Conditions
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Septic Patients

Intervention / Treatment
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* Biological: Blood transfusion


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fresh not-leukocyte-reduced RBCs<br> | Biological: Blood transfusion<br>* RBCs have been transfused in septic patient admitted in ICU<br>|
| Active Comparator: Fresh RBCs leukocyte-reduced<br> | Biological: Blood transfusion<br>* RBCs have been transfused in septic patient admitted in ICU<br>|
| Active Comparator: RBCs with storage longer than 15 days<br> | Biological: Blood transfusion<br>* RBCs have been transfused in septic patient admitted in ICU<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microcirculatory Flow Index (MFI) before and after 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. | One hour after the end of blood transfusion compared with before blood transfusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perfused Vessel Density (PVD) | 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. | One hour after the end of blood transfusion compared with before blood transfusion | 
| StO2 upslope | 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. | One hour after the end of blood transfusion compared with before blood transfusion | 
| 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 |