Circulating Free Hemoglobin and Microcirculation After Administration of Paracetamol in Febrile Septic Patient
1 other identifier
observational
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2016
CompletedFirst Posted
Study publicly available on registry
April 25, 2016
CompletedStudy Start
First participant enrolled
July 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 5, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 5, 2019
CompletedJuly 18, 2019
April 1, 2019
1.9 years
April 16, 2016
July 17, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Perfused Vessel Density (PVD)
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.
30 minutes
Secondary Outcomes (2)
StO2 upload
30 minutes
Microcirculatory flow index (MFI)
30 minutes
Interventions
Paracetamol will be given to febrile septic patients
Eligibility Criteria
50 patients with sepsis or septic shock
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AOU Ospedali Riuniti Ancona - Università Politecnica delle Marche
Ancona, 60126, Italy
Related Publications (1)
Scorcella C, Domizi R, Amoroso S, Carsetti A, Casarotta E, Castaldo P, D'angelo C, Damiani E, Gasparri F, Donati A, Adrario E. Pharmacogenetics in critical care: association between CYP3A5 rs776746 A/G genotype and acetaminophen response in sepsis and septic shock. BMC Anesthesiol. 2023 Feb 16;23(1):55. doi: 10.1186/s12871-023-02018-y.
PMID: 36797680DERIVED
Biospecimen
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.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
April 16, 2016
First Posted
April 25, 2016
Study Start
July 5, 2017
Primary Completion
June 5, 2019
Study Completion
June 5, 2019
Last Updated
July 18, 2019
Record last verified: 2019-04