Clinical trial NCT03314831: The Role of Myristic Acid in Serum for Early Diagnosis of Sepsis and Comparison With Selected Biomarkers of Sepsis
Official title: The Role of Myristic Acid in Serum for Early Diagnosis of Sepsis and Comparison With Selected Biomarkers of Sepsis - Procalcitonin, Presepsin. Correlation With Blood Culture and Detection of Infection by Molecular Biological Methods
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis Syndrome
Systemic Inflammatory Response Syndrome
Keywords: sepsis
septic shock
systemic inflammatory response syndrome
tetradecanoic acid
myristic acid
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2017-10-19
Enrollment: 282
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to ICU in study group, patients with Systemic Inflammatory Response Syndrome after surgery in SIRS group and subjects without systemic inflammation in control group.

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Sepsis or septic shock.
* Systemic inflammatory response syndrome.
* Subjects without systemic inflammation.

Exclusion Criteria:

* There is no exclusion criteria in the study

Primary outcomes:
measure: Serum concentration of Myristic Acid
timeFrame: 5 days
Secondary outcomes:
measure: Correlation of serum concentration of procalcitonin with detection of microbial agents in blood
timeFrame: 5 days
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Department of Anesthesiology and Intensive Care, First Faculty of Medicine, Charles University and Thomayer Hospital
Study officials:
affiliation: Department of Anesthesiology and Intensive Care, First Faculty of Medicine, Charles University and Thomayer Hospital
name: Roman Zazula, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.
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.