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

Septic Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01584999
• Other study ID #: Prot 210163
• Status: Completed
• Phase: Phase 4
• First received: April 23, 2012
• Last updated: May 21, 2012
• Start date: February 2011

Study information

• Verified date: May 2012
• Source: Università Politecnica delle Marche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Septic Patients

Intervention

Biological:
• Blood transfusion
RBCs have been transfused in septic patient admitted in ICU

Locations

Country	Name	City	State
Italy	University ICU, AOU Ospedali Riuniti	Torrette di Ancona	Ancona

Sponsors (2)

Lead Sponsor	Collaborator
Università Politecnica delle Marche	Azienda Ospedaliero, Universitaria Ospedali Riuniti

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Arterial Blood Lactate		One hour after the end of blood transfusion compared with before blood transfusion	No
Secondary	Arterial pH		One hour after the end of blood transfusion compared with before blood transfusion	No
Secondary	SOFA score		One hour after the end of blood transfusion compared with before blood transfusion	No