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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03314831
Other study ID # ACMYR-001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 24, 2017
Est. completion date December 31, 2022

Study information

Verified date February 2023
Source Charles University, Czech Republic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of the study is to measure serum levels of myristic acid in septic patients and to compare them with myristic acid serum levels in patients with Systemic Inflammatory Response Syndrome of non infective etiology and in healthy volunteers. Furthermore, other biomarkers of sepsis are evaluated in comparison with microbiological findings detected either by standard hemocultures or by molecular biological methods.


Description:

Currently, there is an array of biomarkers potentially useful in diagnosis and prognosis in septic patients, either alone or in combination. Only a fraction of them is used in clinical practice. The reasons vary, low sensitivity or specificity is the main one, cost/benefit or difficult processing with the need of highly specialized laboratory to name the other. Recent pilot study from Swedish authors (A.M.Kauppi et al.) published in 2016 showed high correlation of myristic acid levels in blood in patients with sepsis and bacteraemia. There was no other publication on this molecule in relation to sepsis before. Cambiaghi et al. observed its significant decrease in nonresponders to the treatment of septic shock. Myristic acid is an organic acid of linear structure. Measurement of its level will be performed using gas chromatography linked with mass spectrometry.


Recruitment information / eligibility

Status Completed
Enrollment 282
Est. completion date December 31, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Sepsis or septic shock. - Systemic inflammatory response syndrome. - Subjects without systemic inflammation. Exclusion Criteria: - There is no exclusion criteria in the study

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Czechia Department of Anesthesiology and Intensive Care, First Faculty of Medicine, Charles University and Thomayer Hospital Prague

Sponsors (1)

Lead Sponsor Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czechia, 

References & Publications (5)

Cambiaghi A, Pinto BB, Brunelli L, Falcetta F, Aletti F, Bendjelid K, Pastorelli R, Ferrario M. Characterization of a metabolomic profile associated with responsiveness to therapy in the acute phase of septic shock. Sci Rep. 2017 Aug 29;7(1):9748. doi: 10.1038/s41598-017-09619-x. — View Citation

Kauppi AM, Edin A, Ziegler I, Molling P, Sjostedt A, Gylfe A, Stralin K, Johansson A. Metabolites in Blood for Prediction of Bacteremic Sepsis in the Emergency Room. PLoS One. 2016 Jan 22;11(1):e0147670. doi: 10.1371/journal.pone.0147670. eCollection 2016. — View Citation

Prucha M, Bellingan G, Zazula R. Sepsis biomarkers. Clin Chim Acta. 2015 Feb 2;440:97-103. doi: 10.1016/j.cca.2014.11.012. Epub 2014 Nov 18. — View Citation

Prucha M, Zazula R, Russwurm S. Immunotherapy of Sepsis: Blind Alley or Call for Personalized Assessment? Arch Immunol Ther Exp (Warsz). 2017 Feb;65(1):37-49. doi: 10.1007/s00005-016-0415-9. Epub 2016 Aug 24. — View Citation

Zazula R, Prucha M, Tyll T, Kieslichova E. Induction of procalcitonin in liver transplant patients treated with anti-thymocyte globulin. Crit Care. 2007;11(6):R131. doi: 10.1186/cc6202. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Serum concentration of Myristic Acid Serum concentration of Myristic Acid in patients with sepsis or septic shock. Comparison with serum levels of Myristic Acid in patients with systemic inflammatory response syndrome non-infectious etiology and with subjects without systemic inflammation. 5 days
Secondary Correlation of serum concentration of procalcitonin with detection of microbial agents in blood Comparison of procalcitonin concentration in serum with the results of blood culture using methods of classical microbiology and with molecular biological methods for the detection of microbial agents. 5 days
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