The Role of Myristic Acid in Serum for Early Diagnosis of Sepsis and Comparison With Selected Biomarkers of Sepsis

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

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.

Study Overview

• Status: Completed
• Conditions: Systemic Inflammatory Response Syndrome; Sepsis Syndrome

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.

• Study Type: Observational
• Enrollment (Actual): 282

Contacts and Locations

Study Locations

• Czechia
  • Prague, Czechia, 14059
    • Department of Anesthesiology and Intensive Care, First Faculty of Medicine, Charles University and Thomayer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Sepsis; Patients with sepsis or septic shock admitted on Intensive Care Unit.
Systemic Inflammatory Response Syndrome; Patients with Systemic Inflammatory Response Syndrome non-infectious etiology.
No inflammation; Patients without systemic inflammation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Charles University, Czech Republic
• Investigators: Principal Investigator: Roman Zazula, MD, Department of Anesthesiology and Intensive Care, First Faculty of Medicine, Charles University and Thomayer Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 24, 2017
• Primary Completion (ACTUAL): December 31, 2021
• Study Completion (ACTUAL): December 31, 2022

Study Registration Dates

• First Submitted: October 16, 2017
• First Submitted That Met QC Criteria: October 16, 2017
• First Posted (ACTUAL): October 19, 2017

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2023
• Last Update Submitted That Met QC Criteria: February 13, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: septic shock; sepsis; systemic inflammatory response syndrome; tetradecanoic acid; myristic acid
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Inflammation; Disease; Shock; Sepsis; Toxemia; Syndrome; Systemic Inflammatory Response Syndrome
• Other Study ID Numbers: ACMYR-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No