Systemic Inflammatory Response Syndrome (SIRS)NCT07476391
Myostatin and Irisin Levels in Predicting the Outcome of Patients With Systemic Inflammation: A Prospective Observational Study
An observational study of Systemic Inflammatory Response Syndrome (SIRS), run by Charles University, Czech Republic at 1 site in Czechia.
Trial summary
Systemic inflammatory response syndrome (SIRS) is associated with severe metabolic stress that can lead to rapid breakdown of skeletal muscle and the development of stress-related malnutrition. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Systemic Inflammatory Response Syndrome (SIRS)
- How many people
- 54 participants
- Where
- 1 siteCzechia
- Study dates
- 20 Apr 2023to 11 Nov 2025
- 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: Study group consisted of patients admitted to General University Hospital in Prague with acute illness fulfilling the inclusion criteria. Healthy controls consisted of healthy volunteers free of acute or chronic illnesses that could confound study outcomes (any autoimmune, inflammatory, cardiovascular, metabolic, or other systemic disease requiring treatment).
Who may be able to join
- Age ≥18 years
- Hospital admission with acute illness
- Presence of systemic inflammatory response syndrome (SIRS) defined by at least two of the following:
- body temperature >38°C or <36°C heart rate >90 bpm respiratory rate >20/min or PaCO₂ <4.3 kPa leukocytosis >12 × 10⁹/L or leukopenia <4 × 10⁹/L
- Expected hospital stay ≥5 days
- Ability to provide informed consent
Who cannot join
- Transfer from another hospital with prior hospitalization >48 hours
- Terminal illness (malignant or non-malignant)
- Long-term immobility prior to hospital admission
- Conditions preventing participation in study procedures
Trial locations and contacts
1 site in 1 country.
About this study
Systemic inflammatory response syndrome (SIRS) is associated with severe metabolic stress that can lead to rapid breakdown of skeletal muscle and the development of stress-related malnutrition. These processes often result in muscle weakness, delayed recovery, prolonged hospital stay, and increased morbidity and mortality in affected patients.
In recent years, increasing attention has been paid to signaling molecules produced by skeletal muscles, known as myokines. Myokines influence not only muscle regeneration and muscle breakdown but also have a wide range of effects on other organs and tissues in the body, including the brain and gastrointestinal tract. Previous studies suggest that lower levels of certain myokines, such as myostatin and irisin, may be associated with worse outcomes in critically ill patients.
Read more
The primary aim of this prospective observational study is to evaluate the association between the levels of selected myokines and prolonged hospital stay in patients with systemic inflammation. If such an association is confirmed, myokines could potentially serve as prognostic biomarkers for the development of muscle dysfunction and prolonged hospitalization.
Secondary objectives include evaluating correlations between myokine levels and other indicators of systemic inflammation and muscle dysfunction. In addition, the study assesses the potential use of bedside ultrasound measurement of the quadriceps muscle to detect muscle catabolism and to help predict clinical outcomes in hospitalized patients.
Read the detailed description
Muscle weakness develops in a substantial proportion of critically ill patients and is particularly common among those with systemic inflammatory conditions, especially sepsis. The pathogenesis of muscle weakness in critical illness is multifactorial and includes persistent catabolic metabolism, immobilization, and mechanical ventilation, as well as molecular alterations such as mitochondrial dysfunction, oxidative stress, impaired autophagy, and changes in ion channel regulation. These processes lead to accelerated muscle atrophy and functional impairment.
Skeletal muscle also plays an active role in systemic metabolic and inflammatory processes through the secretion of myokines, a group of peptide or protein signaling molecules with autocrine, paracrine, and endocrine effects. Among the best characterized myokines are myostatin and irisin. Myostatin is known to inhibit muscle protein synthesis and promote muscle protein degradation, thereby suppressing muscle growth and differentiation. Irisin has been associated with regulation of thermogenesis, energy metabolism, and skeletal muscle adaptation.
Previous studies have suggested that circulating levels of these myokines may be associated with metabolic dysfunction, muscle mass, and clinical outcomes in various patient populations. However, prospective clinical studies examining the role of myokines in patients with systemic inflammatory states remain limited.
This single-center prospective observational pilot study aims to investigate the relationship between circulating levels of myostatin and irisin and clinical outcomes in patients with systemic inflammatory conditions. In addition to clinical outcomes, the study evaluates associations between myokine concentrations and laboratory markers of inflammation, anthropometric parameters, muscle strength, and ultrasound-derived measures of quadriceps muscle thickness. Bedside ultrasound measurement of quadriceps muscle thickness is also evaluated as a potential non-invasive method for monitoring muscle loss during acute illness.
The study was registered retrospectively after completion of participant enrollment.
- Keywords
- myokines, critical illness, systemic inflammation, muscle ultrasound
- Medical subject headings
- Systemic Inflammatory Response Syndrome, Critical Illness
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 |
|---|---|---|
| SIRS patients | Patients admitted to hospital with acute illness fulfilling criteria for systemic inflammatory response syndrome (SIRS). | |
| Healthy Controls | Healthy individuals without acute or chronic disease, matched to patients by age and sex where applicable. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Total number of days from hospital admission to hospital discharge alive.
Measured: From hospital admission until hospital discharge (up to 90 days).
Secondary outcomes (5)
Baseline circulating myostatin level
Association between baseline serum myostatin concentration and clinical and functional parameters.
Measured: Within 48 hours after hospital admission.
Baseline circulating irisin level
Association between baseline serum irisin concentration and clinical and functional parameters.
Measured: Within 48 hours after hospital admission.
Quadriceps muscle thickness
Association between ultrasound-derived measurement of quadriceps femoris muscle thickness and clinical and functional parameters
Measured: Baseline (within 48 hours after admission) and day 10 of hospitalization.
Handgrip strength
Muscle strength measured using a handheld dynamometer and its associations with clinical and functional parameters.
Measured: Baseline (within 48 hours after admission) and day 10 of hospitalization.
Composite adverse outcome (BAD)
Composite outcome defined as hospital length of stay above the 75th percentile, ICU length of stay above the 75th percentile, transfer to long-term care facility, or death.
Measured: During hospitalization (up to 90 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start20 Apr 2023
- Primary completion7 Apr 2025
- Study completion11 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Inflammatory Response Syndrome (SIRS)Studies 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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- General University Hospital, Prague
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07476391
- Sponsor's protocol ID
- GIP-23-SL-06
- Status last verified
- Mar 2026
- First submitted
- 12 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myostatin and Irisin Levels in Predicting the Outcome of Patients With Systemic Inflammation: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07476391
- Acronym / sponsor ID
- GIP-23-SL-06
- Keywords
- myokines, critical illness, systemic inflammation, muscle ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Collaborators
- General University Hospital, Prague
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 7 Apr 2025 (actual)
- Study completion
- 11 Nov 2025 (actual)
- First posted
- 17 Mar 2026 (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.
Systemic inflammatory response syndrome (SIRS) is associated with severe metabolic stress that can lead to rapid breakdown of skeletal muscle and the development of stress-related malnutrition. These processes often result in muscle weakness, delayed recovery, prolonged hospital stay, and increased morbidity and mortality in affected patients.
In recent years, increasing attention has been paid to signaling molecules produced by skeletal muscles, known as myokines. Myokines influence not only muscle regeneration and muscle breakdown but also have a wide range of effects on other organs and tissues in the body, including the brain and gastrointestinal tract. Previous studies suggest that lower levels of certain myokines, such as myostatin and irisin, may be associated with worse outcomes in critically ill patients.
The primary aim of this prospective observational study is to evaluate the association between the levels of selected myokines and prolonged hospital stay in patients with systemic inflammation. If such an association is confirmed, myokines could potentially serve as prognostic biomarkers for the development of muscle dysfunction and prolonged hospitalization.
Secondary objectives include evaluating correlations between myokine levels and other indicators of systemic inflammation and muscle dysfunction. In addition, the study assesses the potential use of bedside ultrasound measurement of the quadriceps muscle to detect muscle catabolism and to help predict clinical outcomes in hospitalized patients.
Detailed description
Muscle weakness develops in a substantial proportion of critically ill patients and is particularly common among those with systemic inflammatory conditions, especially sepsis. The pathogenesis of muscle weakness in critical illness is multifactorial and includes persistent catabolic metabolism, immobilization, and mechanical ventilation, as well as molecular alterations such as mitochondrial dysfunction, oxidative stress, impaired autophagy, and changes in ion channel regulation. These processes lead to accelerated muscle atrophy and functional impairment.
Skeletal muscle also plays an active role in systemic metabolic and inflammatory processes through the secretion of myokines, a group of peptide or protein signaling molecules with autocrine, paracrine, and endocrine effects. Among the best characterized myokines are myostatin and irisin. Myostatin is known to inhibit muscle protein synthesis and promote muscle protein degradation, thereby suppressing muscle growth and differentiation. Irisin has been associated with regulation of thermogenesis, energy metabolism, and skeletal muscle adaptation.
Previous studies have suggested that circulating levels of these myokines may be associated with metabolic dysfunction, muscle mass, and clinical outcomes in various patient populations. However, prospective clinical studies examining the role of myokines in patients with systemic inflammatory states remain limited.
This single-center prospective observational pilot study aims to investigate the relationship between circulating levels of myostatin and irisin and clinical outcomes in patients with systemic inflammatory conditions. In addition to clinical outcomes, the study evaluates associations between myokine concentrations and laboratory markers of inflammation, anthropometric parameters, muscle strength, and ultrasound-derived measures of quadriceps muscle thickness. Bedside ultrasound measurement of quadriceps muscle thickness is also evaluated as a potential non-invasive method for monitoring muscle loss during acute illness.
The study was registered retrospectively after completion of participant enrollment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SIRS patients | – | –Patients admitted to hospital with acute illness fulfilling criteria for systemic inflammatory response syndrome (SIRS). |
| Healthy Controls | – | –Healthy individuals without acute or chronic disease, matched to patients by age and sex where applicable. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study group consisted of patients admitted to General University Hospital in Prague with acute illness fulfilling the inclusion criteria. Healthy controls consisted of healthy volunteers free of acute or chronic illnesses that could confound study outcomes (any autoimmune, inflammatory, cardiovascular, metabolic, or other systemic disease requiring treatment).
Key inclusion criteria (6 listed)
- Age ≥18 years
- Hospital admission with acute illness
- Presence of systemic inflammatory response syndrome (SIRS) defined by at least two of the following:
- body temperature >38°C or <36°C heart rate >90 bpm respiratory rate >20/min or PaCO₂ <4.3 kPa leukocytosis >12 × 10⁹/L or leukopenia <4 × 10⁹/L
- Expected hospital stay ≥5 days
Key exclusion criteria (4 listed)
- Transfer from another hospital with prior hospitalization >48 hours
- Terminal illness (malignant or non-malignant)
- Long-term immobility prior to hospital admission
- Conditions preventing participation in study procedures
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
Length of hospital stay
Time frame: From hospital admission until hospital discharge (up to 90 days).
Total number of days from hospital admission to hospital discharge alive.
5 secondary outcomes
Baseline circulating myostatin level
Time frame: Within 48 hours after hospital admission.
Baseline circulating irisin level
Time frame: Within 48 hours after hospital admission.
Quadriceps muscle thickness
Time frame: Baseline (within 48 hours after admission) and day 10 of hospitalization.
Handgrip strength
Time frame: Baseline (within 48 hours after admission) and day 10 of hospitalization.
Composite adverse outcome (BAD)
Time frame: During hospitalization (up to 90 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 17 Mar 2026.
Related trials for Systemic Inflammatory Response Syndrome (SIRS)
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Systemic Inflammatory Response Syndrome (SIRS), 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 6 inclusion and 4 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 17 Mar 2026. 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?
Length of hospital stay (time frame: From hospital admission until hospital discharge (up to 90 days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2026.