Metabolomics Study on Intensive Care Acquired Muscle Weakness in Polytrauma

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03819959

Acronym

MIRACLE II

Enrollment

Registered

2019-01-29

Start date

2019-03-24

Completion date

2020-04-22

Last updated

2020-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Care, Critical Illness, Critical Illness Myopathy, Critical Illness Polyneuropathy, Intensive Care (ICU) Myopathy, Metabolomics, Muscle Weakness

Keywords

Pilot Trial, Muscle Biopsy, Blood Metabolome

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Metabolomics	a median of 14 days	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

Secondary

Measure	Time frame	Description
Muscle histology	a median of 14 days	Immunohistochemistry will be done in muscle samples. All samples will be screened for changes in the muscular structure and correlation with blood metabolome changes.
Phosphoproteomics	a median of 14 days	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.

Other

Measure	Time frame	Description
Identify possible predictors of muscle wasting in the blood metabolome at ICU admission	a median of 14 days	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.

Countries

Germany

Outcome results