Sepsis SyndromeNCT03314831
The Role of Myristic Acid in Serum for Early Diagnosis of Sepsis and Comparison With Selected Biomarkers of Sepsis
An observational study of Sepsis Syndrome and Systemic Inflammatory Response Syndrome, run by Charles University, Czech Republic at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sepsis Syndrome, Systemic Inflammatory Response Syndrome
- How many people
- 282 participants
- Where
- 1 siteCzechia
- Study dates
- 24 Oct 2017to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Sepsis or septic shock.
- Systemic inflammatory response syndrome.
- Subjects without systemic inflammation.
Who cannot join
- There is no exclusion criteria in the study
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Department of Anesthesiology and Intensive Care, First Faculty of Medicine, Charles University and Thomayer Hospital
Prague, 14059
About this study
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
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.
Read the 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.
- Keywords
- sepsis, septic shock, systemic inflammatory response syndrome, tetradecanoic acid, myristic acid
- Medical subject headings
- Systemic Inflammatory Response Syndrome, Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 days
Secondary outcomes (1)
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.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2017
- Study start24 Oct 2017
- Primary completion31 Dec 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Sepsis SyndromeStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roman Zazula, MD, PhD, Charles University, Czech Republic
- Investigators
- Roman Zazula, MD, Principal investigator, Department of Anesthesiology and Intensive Care, First Faculty of Medicine, Charles University and Thomayer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03314831
- Sponsor's protocol ID
- ACMYR-001
- Status last verified
- Feb 2023
- First submitted
- 16 Oct 2017
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26800189Cambiaghi 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.
PubMed 28851978Prucha 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.
PubMed 25447700Prucha 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.
PubMed 27554587Zazula 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.
PubMed 18088403
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03314831
- Acronym / sponsor ID
- ACMYR-001
- Keywords
- sepsis, septic shock, systemic inflammatory response syndrome, tetradecanoic acid, myristic acid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 24 Oct 2017 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 19 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Sepsis or septic shock.
- Systemic inflammatory response syndrome.
- Subjects without systemic inflammation.
Key exclusion criteria (1 listed)
- There is no exclusion criteria in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum concentration of Myristic Acid
Time frame: 5 days
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.
1 secondary outcome
Correlation of serum concentration of procalcitonin with detection of microbial agents in blood
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Background: PubMed 26800189Kauppi 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.
- Background: PubMed 28851978Cambiaghi 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.
- Background: PubMed 25447700Prucha 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.
- Background: PubMed 27554587Prucha 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.
- Background: PubMed 18088403Zazula 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roman Zazula, MD principal investigator
Department of Anesthesiology and Intensive Care, First Faculty of Medicine, Charles University and Thomayer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis Syndrome and Systemic Inflammatory Response Syndrome, run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum concentration of Myristic Acid (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03314831, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.