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Completed

NCT Number: NCT01584999

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

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.

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Key information

Conditions

Septic Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University ICU, AOU Ospedali Riuniti

Torrette Di Ancona, Ancona, 60126, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Blood transfusion

Biological

RBCs have been transfused in septic patient admitted in ICU

Primary outcomes

  1. 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

  1. Perfused Vessel Density (PVD)

    Time frame: 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.

  2. StO2 upslope

    Time frame: 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.

  3. Arterial Blood Lactate

    Time frame: One hour after the end of blood transfusion compared with before blood transfusion

  4. Arterial pH

    Time frame: One hour after the end of blood transfusion compared with before blood transfusion

  5. SOFA score

    Time frame: One hour after the end of blood transfusion compared with before blood transfusion

Sponsors and collaborators

Lead sponsor

Università Politecnica delle Marche

Other

Collaborators

  • Azienda Ospedaliero, Universitaria Ospedali Riuniti

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
First posted
Apr 25, 2012
Registry last updated
May 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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