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Circulating Free Hemoglobin and Microcirculation After Administration of Paracetamol in Febrile Septic Patient

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ClinicalTrials.gov Identifier: NCT02750163
Recruitment Status : Completed
First Posted : April 25, 2016
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Abele Donati, MD, Università Politecnica delle Marche

Brief Summary:
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.

Condition or disease Intervention/treatment
Sepsis and Septic Shock Drug: paracetamol

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Circulating Free Hemoglobin and Microcirculation After Administration of Paracetamol in Febrile Septic Patient
Actual Study Start Date : July 5, 2017
Actual Primary Completion Date : June 5, 2019
Actual Study Completion Date : June 5, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever


Intervention Details:
  • Drug: paracetamol
    Paracetamol will be given to febrile septic patients


Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
50 patients with sepsis or septic shock
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • age < 18 years
  • pregnancy
  • hemodialysis
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02750163


Locations
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Italy
AOU Ospedali Riuniti Ancona - Università Politecnica delle Marche
Ancona, Italy, 60126
Sponsors and Collaborators
Università Politecnica delle Marche

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Responsible Party: Abele Donati, MD, Associate Professor, Università Politecnica delle Marche
ClinicalTrials.gov Identifier: NCT02750163     History of Changes
Other Study ID Numbers: FreeHb
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: April 2019

Additional relevant MeSH terms:
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Shock, Septic
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics