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

Phase 4

Completed

• Conditions: Septic Patients
• Interventions: Biological: Blood transfusion

• Registration Number: NCT01584999
• Lead Sponsor: Università Politecnica delle Marche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Primary Completion: 2012-02
• Study First Submitted: 2012-04-23
• Study First Submitted QC: 2012-04-23
• Study First Posted: 2012-04-25
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-21
• Last Update Posted: 2012-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fresh not-leukocyte-reduced RBCs	Blood transfusion	-
Fresh RBCs leukocyte-reduced	Blood transfusion	-
RBCs with storage longer than 15 days	Blood transfusion	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University ICU, AOU Ospedali Riuniti; 🇮🇹 Torrette di Ancona, Ancona, Italy