Study on muscle weakness after surgery in intensive care patients
Metabolomics Pilot Study on Postoperative Intensive Care Acquired Muscle Weakness (MIRACLE-I Study)
This study is testing if changes in blood and muscle samples from surgical patients can help us understand and find markers for muscle weakness that happens after being in intensive care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Technical University of Munich Academic / other |
| Locations | 3 sites (Vienna, State of Vienna and 2 other locations) |
| Trial ID | NCT03810768 on ClinicalTrials.gov |
What this trial studies
This observational pilot trial focuses on surgical patients at high risk for intensive care unit admission. Participants will undergo blood and muscle sample collection at specific time points to analyze metabolic, histological, and molecular changes. The study aims to investigate alterations in the blood metabolome associated with intensive care unit acquired weakness (ICUAW) and to identify potential metabolic markers for this condition.
Who should consider this trial
Good fit: Ideal candidates are invasive mechanically ventilated critically ill postoperative patients aged 18 and older with an expected ICU stay of more than three days.
Not a fit: Patients receiving non-curative care or those classified as moribund may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and potential markers for muscle weakness in critically ill patients, improving patient outcomes.
How similar studies have performed: While this approach is novel, similar studies in metabolomics have shown promise in understanding critical illness-related conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * invasive mechanically ventilated critically ill patient with expected intensive care unit stay \> 3 days * postoperative patient * ≥ 18 years old * American Society of Anesthesiology (ASA) classification ≥ III Exclusion Criteria: * moribund patient * non-curative care (comfort care)
Where this trial is running
Vienna, State of Vienna and 2 other locations
- Medical University of Vienna — Vienna, State of Vienna, Austria (Recruiting)
- Klinikum rechts der Isar, School of Medicine, Technical University of Munich — Munich, Bavaria, Germany (Active_not_recruiting)
- Charité - Universitätsmedizin Berlin — Berlin, State of Berlin, Germany (Active_not_recruiting)
Study contacts
- Principal investigator: Stefan J Schaller, MD — Technical University of Munich
- Study coordinator: Stefan J Schaller, MD
- Email: stefan.schaller@meduniwien.ac.at
- Phone: +4314040041020
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.