Metabolomics Study on Postoperative Intensive Care Acquired Muscle Weakness

Critical Illness Clinical Trial

— MIRACLE I  

Official title:

Metabolomics Pilot Study on Postoperative Intensive Care Acquired Muscle Weakness (MIRACLE-I Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03810768
• Other study ID #: MIRACLE I
• Status: Recruiting
• 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
• 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
• 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)

Related Conditions & MeSH terms

• Asthenia
• Critical Care
• Critical Illness
• Critical Illness Myopathy
• Critical Illness Polyneuropathy
• Intensive Care (ICU) Myopathy
• Metabolomics
• Muscle Weakness
• Muscular Diseases
• Paresis
• Polyneuropathies

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