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NCT Number: NCT03819959

Metabolomics Study on Intensive Care Acquired Muscle Weakness in Polytrauma

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.

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Key information

Conditions

Metabolomics Critical Care Critical Illness Critical Illness Myopathy Critical Illness Polyneuropathy Disease Attributes Intensive Care (ICU) Myopathy Muscle Weakness Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Polyneuropathies Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum rechts der Isar, School of Medicine, Technical University of Munich

Munich, Bavaria, 81675, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Metabolomics

    Time frame: 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 outcomes

  1. Muscle histology

    Time frame: 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.

  2. Phosphoproteomics

    Time frame: 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 outcomes

  1. Identify possible predictors of muscle wasting in the blood metabolome at ICU admission

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Collaborators

  • Helmholtz Zentrum München

Registry information

Official study title

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

Acronym: MIRACLE II

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 29, 2019
Registry last updated
Oct 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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