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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03810768
Other study ID # MIRACLE I
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 2, 2022
Est. completion date December 31, 2024

Study information

Verified date November 2023
Source Technical University of Munich
Contact Stefan J Schaller, MD
Phone +49-89-4140-9635
Email s.schaller@tum.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

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)

Study Design


Locations

Country Name City State
Germany Charité - Universitätsmedizin Berlin Berlin
Germany Klinikum rechts der Isar, School of Medicine, Technical University of Munich Munich Bavaria

Sponsors (3)

Lead Sponsor Collaborator
Technical University of Munich Charite University, Berlin, Germany, Helmholtz Zentrum München

Country where clinical trial is conducted

Germany, 

Outcome

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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