Myostatin and Irisin Levels in Predicting the Outcome of Patients With Systemic Inflammation: A Prospective Observational Study

NCT07476391 | Completed DMC

• 1 other identifier: GIP-23-SL-06
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Systemic Inflammatory Response Syndrome (SIRS)

Keywords

myokines; critical illness; systemic inflammation; muscle ultrasound

Outcome Measures

Primary Outcomes (1)

• Length of hospital stay

  Total number of days from hospital admission to hospital discharge alive.

  From hospital admission until hospital discharge (up to 90 days).

Secondary Outcomes (5)

• Baseline circulating myostatin level

  Within 48 hours after hospital admission.

• Baseline circulating irisin level

  Within 48 hours after hospital admission.

• Quadriceps muscle thickness

  Baseline (within 48 hours after admission) and day 10 of hospitalization.

• Handgrip strength

  Baseline (within 48 hours after admission) and day 10 of hospitalization.

• Composite adverse outcome (BAD)

  During hospitalization (up to 90 days).

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charles University, Czech Republic: lead
• General University Hospital, Prague: collaborator

Study Sites (1)

General University Hospital in Prague

Prague, 12000, Czechia

Location

MeSH Terms

Conditions

Systemic Inflammatory Response Syndrome; Critical Illness

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Disease Attributes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 17, 2026
• Study Start: April 20, 2023
• Primary Completion: April 7, 2025
• Study Completion: November 11, 2025
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

CZ (1)