Critical Illness Clinical Trial
— MIRACLE IOfficial title:
Metabolomics Pilot Study on Postoperative Intensive Care Acquired Muscle Weakness (MIRACLE-I Study)
In this mono-center pilot trial, surgical patients who are at high risk to be admitted to intensive care will be screened and asked for participation. We are going to take blood and muscle samples at respecified time points to do metabolic, histological and molecular testing. Aim of the study is to investigate (1) changes of the blood metabolome in patients with ICUAW (intensive care unit acquired weakness) and (2) identify metabolic components who are responsible for ICUAW or can be used as marker for ICUAW.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | December 31, 2024 |
Est. primary completion date | November 1, 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Germany | Charité - Universitätsmedizin Berlin | Berlin | |
Germany | Klinikum rechts der Isar, School of Medicine, Technical University of Munich | Munich | Bavaria |
Lead Sponsor | Collaborator |
---|---|
Technical University of Munich | Charite University, Berlin, Germany, Helmholtz Zentrum München |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Identify possible predictors of muscle wasting in the blood metabolome preoperatively | Among the blood metabolome that will be measured, identify metabolites or combinations of metabolites whose high or low concentration(s) preoperatively associate(s) with the amount of muscle loss. These metabolites are candidate biomarkers that could be used to identify individuals at risk of large muscle wasting and may give further insights into the mechanisms of muscle wasting. | a median of 14 days | |
Other | Identify possible predictors of muscle wasting in the blood metabolome at ICU admission | Among the blood metabolome that will be measured, identify metabolites or combinations of metabolites whose high or low concentration(s) at ICU admission associate(s) with the amount of muscle loss. These metabolites are candidate biomarkers that could be used to identify individuals at risk of large muscle wasting and may give further insights into the mechanisms of muscle wasting. | a median of 14 days | |
Primary | Metabolomics | Blood Metabolome will be isolated from blood samples. All samples will be screened for influence of Intensive Care Unit Acquired Weakness (ICUAW) using mass spectrometry. | a median of 14 days | |
Secondary | Muscle histology | Immunohistochemistry will be done in muscle samples. All samples will be screened for influence of Intensive Care Unit Acquired Weakness (ICUAW) and correlation with blood metabolome changes. | a median of 14 days | |
Secondary | Phosphoproteomics | Phosphoproteomics will be done in muscle samples using mass spectrometry. All samples will be screened for influence of Intensive Care Unit Acquired Weakness (ICUAW) and correlation with blood metabolome changes. | a median of 14 days |
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