NCT03314831

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
282

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 19, 2017

Completed
5 days until next milestone

Study Start

First participant enrolled

October 24, 2017

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

February 14, 2023

Status Verified

February 1, 2023

Enrollment Period

4.2 years

First QC Date

October 16, 2017

Last Update Submit

February 13, 2023

Conditions

Keywords

sepsisseptic shocksystemic inflammatory response syndrometetradecanoic acidmyristic acid

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Correlation of serum concentration of procalcitonin with detection of microbial agents in blood

    5 days

Study Arms (3)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Intensive Care, First Faculty of Medicine, Charles University and Thomayer Hospital

Prague, 14059, Czechia

Location

Related Publications (5)

  • 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.

    PMID: 26800189BACKGROUND
  • 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.

    PMID: 28851978BACKGROUND
  • 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.

    PMID: 25447700BACKGROUND
  • 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.

    PMID: 27554587BACKGROUND
  • 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.

    PMID: 18088403BACKGROUND

MeSH Terms

Conditions

Systemic Inflammatory Response SyndromeSepsisShock, Septic

Condition Hierarchy (Ancestors)

InflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShockInfections

Study Officials

  • Roman Zazula, MD

    Department of Anesthesiology and Intensive Care, First Faculty of Medicine, Charles University and Thomayer Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Department of Anesthesiology and Critical Care

Study Record Dates

First Submitted

October 16, 2017

First Posted

October 19, 2017

Study Start

October 24, 2017

Primary Completion

December 31, 2021

Study Completion

December 31, 2022

Last Updated

February 14, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations