Metabolomics Study on Intensive Care Acquired Muscle Weakness in Polytrauma

Critical Illness Clinical Trial

— MIRACLE II  

Official title:

Metabolomics Pilot Study on Intensive Care Acquired Muscle Weakness in Polytrauma (MIRACLE-II Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03819959
• Other study ID #: MIRACLE II
• Status: Completed
• Start date: March 24, 2019
• Est. completion date: April 22, 2020

Study information

• Verified date: October 2020
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this mono-center pilot trial, polytrauma patients admitted to intensive care will be included. Investigators 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: Completed
• Enrollment: 10
• Est. completion date: April 22, 2020
• Est. primary completion date: April 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• acute polytrauma patient

• age = 18 years old

• expected intensive care stay = 3 days

• American Society of Anesthesiologists classification I or II

Exclusion Criteria:

• patient had received cardiopulmonary resuscitation

• limitation of therapy or comfort care

Related Conditions & MeSH terms

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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Technische Universität München	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 at ICU admission	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 changes in the blood metabolome during muscle wasting (i.e. Intensive Care Unit Acquired Weakness) using mass spectrometry	a median of 14 days
Secondary	Muscle histology	Immunohistochemistry will be done in muscle samples. All samples will be screened for changes in the muscular structure 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 muscular changes (i.e. Intensive Care Unit Acquired Weakness (ICUAW)) and correlation with blood metabolome changes.	a median of 14 days