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NCT Number: NCT03810768

Metabolomics Study on Postoperative Intensive Care Acquired Muscle Weakness

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.

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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

Medical University of Vienna, Vienna, State of Vienna, Austria

Loading trial locations.

Who can participate

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

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)

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 influence of Intensive Care Unit Acquired Weakness (ICUAW) 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 influence of Intensive Care Unit Acquired Weakness (ICUAW) 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 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 preoperatively

    Time frame: a median of 14 days

    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.

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

    Time frame: a median of 14 days

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marian Demitsch

CONTACT

[email protected]

+4314040041020

Stefan J Schaller, MD

CONTACT

[email protected]

+4314040041020

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Collaborators

  • Charite University, Berlin, Germany
  • Helmholtz Zentrum München
  • Medical University of Vienna

Registry information

Official study title

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

Acronym: MIRACLE I

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jan 22, 2019
Registry last updated
Mar 3, 2026

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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