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Clinical Trials/NCT01584999
NCT01584999
Completed
Phase 4

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

Università Politecnica delle Marche1 site in 1 country30 target enrollmentFebruary 2011
ConditionsSeptic Patients

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Septic Patients
Sponsor
Università Politecnica delle Marche
Enrollment
30
Locations
1
Primary Endpoint
Microcirculatory Flow Index (MFI) before and after blood transfusion.
Status
Completed
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2011
End Date
February 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Università Politecnica delle Marche
Responsible Party
Principal Investigator
Principal Investigator

Abele Donati, MD

Associate Professor

Università Politecnica delle Marche

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)

Outcomes

Primary Outcomes

Microcirculatory Flow Index (MFI) before and after blood transfusion.

Time Frame: 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 Outcomes

  • Perfused Vessel Density (PVD)(One hour after the end of blood transfusion compared with before blood transfusion)
  • StO2 upslope(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)

Study Sites (1)

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