Circulating Free Hemoglobin and Microcirculation After Administration of Paracetamol in Febrile Septic Patient
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ClinicalTrials.gov Identifier: NCT02750163
Recruitment Status :
First Posted : April 25, 2016
Last Update Posted : July 18, 2019
Università Politecnica delle Marche
Information provided by (Responsible Party):
Abele Donati, MD, Università Politecnica delle Marche
The aim of this study is to evaluate the effect of Acetaminophen on the main parameters of microcirculation, on the plasmatic levels of free hemoglobin/oxidative stress markers and on the expression of PD1/Pd-L1, in pyrexial septic patient.
Perfused Vessel Density (PVD) [ Time Frame: 30 minutes ]
The perfused vessel density (PVD), unit of measure mm/mm2, is detected in vivo by Incident Dark Field Imaging at sublingual microcirculation. It represents the quantity of well perfused vessels at microcirculatory level.
Secondary Outcome Measures :
StO2 upload [ Time Frame: 30 minutes ]
StO2 upslope (%/min) 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.
Microcirculatory flow index (MFI) [ Time Frame: 30 minutes ]
Microcirculatory Flow Index detected in vivo by Incident Dark Field Imaging at sublingual microcirculation. It represents the quality of blood flow at microcirculatory level.
Biospecimen Retention: Samples Without DNA
Dosage of free hemoglobin; dosage of oxidative markers as F2-isoprostane F2 and-isoflurane, sindecan-1, heparasulfate and hyaluronic acid, endothelin-1, plasma assay of NO, reduced glutathione, haptoglobin and hemopexin, PD-1/PD-L1.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
50 patients with sepsis or septic shock
Patients with sepsis, severe sepsis and septic shock with high body temperature that need administration of Paracetamol and which have previously monitored blood pressure and have a central venous catheter in place.
age < 18 years
hemolysis of the blood sample
use of Paracetamol in the previous 12 hours
conditions that do not allow the possibility of getting a monitoring of sublingual microcirculation (maxillofacial trauma, serious inability to jaw, copious blood loss or secretions from the mouth)