Clinical trial NCT01584999: Effects on Septic Patient's Microcirculation of the Transfusion of Different Types of Concentrated RBCs.
Official title: Effects on the Septic Patient's Microcirculation of the Transfusion of Three Different Types of Concentrated Red Blood Cells.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Septic Patients
Lead sponsor: Università Politecnica delle Marche
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliero, Universitaria Ospedali Riuniti
First posted: 2012-04-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Microcirculatory Flow Index (MFI) before and after blood transfusion.
timeFrame: One hour after the end of blood transfusion compared with before blood transfusion
Secondary outcomes:
measure: Perfused Vessel Density (PVD)
timeFrame: One hour after the end of blood transfusion compared with before blood transfusion
measure: StO2 upslope
timeFrame: One hour after the end of blood transfusion compared with before blood transfusion
measure: Arterial Blood Lactate
timeFrame: One hour after the end of blood transfusion compared with before blood transfusion
measure: Arterial pH
timeFrame: One hour after the end of blood transfusion compared with before blood transfusion
measure: SOFA score
timeFrame: One hour after the end of blood transfusion compared with before blood transfusion
Other outcomes:
Locations:
city: Torrette di Ancona
country: Italy
facility: University ICU, AOU Ospedali Riuniti
state: Ancona
Study officials:
affiliation: Università Politecnica delle Marche
name: Abele Donati, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Damiani E, Adrario E, Luchetti MM, Scorcella C, Carsetti A, Mininno N, Pierantozzi S, Principi T, Strovegli D, Bencivenga R, Gabrielli A, Romano R, Pelaia P, Ince C, Donati A. Plasma free hemoglobin and microcirculatory response to fresh or old blood transfusions in sepsis. PLoS One. 2015 May 1;10(5):e0122655. doi: 10.1371/journal.pone.0122655. eCollection 2015.
citation: Donati A, Damiani E, Luchetti M, Domizi R, Scorcella C, Carsetti A, Gabbanelli V, Carletti P, Bencivenga R, Vink H, Adrario E, Piagnerelli M, Gabrielli A, Pelaia P, Ince C. Microcirculatory effects of the transfusion of leukodepleted or non-leukodepleted red blood cells in patients with sepsis: a pilot study. Crit Care. 2014 Feb 17;18(1):R33. doi: 10.1186/cc13730.