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RecruitingNCT03810768MIRACLE IUpdated Mar 3, 2026

Metabolomics Study on Postoperative Intensive Care Acquired Muscle Weakness

An observational study in Metabolomics, Critical Care and Critical Illness, sponsored by Technical University of Munich. Recruiting at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-03.

Primary conditionPolyneuropathiesRegistry: Critical IllnessReclassifiedWhy we changed it
Registry
Critical Illness — the first condition term the registry derived for this study.
ClinicalTrials.gg
Polyneuropathies
Why
  1. Critical Illness is a broad heading, used only when no more specific condition is named.
  2. The study's listed conditions name Polyneuropathies.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Technical University of Munich · Observational

From the registry’s dates

  • Started Sep 2022; still recruiting 4 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

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

Browse trials for

Keywords

  • pilot trial
  • muscle biopsy
  • blood metabolome
03

In context

Polyneuropathies Reclassified

133 studies on the registry are indexed under Polyneuropathies; 33 are open to participants now.

This study's planned enrollment of 20 is below the median of 100 across 53 observational studies indexed under Polyneuropathies.

Browse Polyneuropathies studies →

Lead sponsor

Technical University of Munich is the lead sponsor of 320 studies on the registry; 58 are open to participants now.

Compared within Polyneuropathies, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Critical Illness. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

mechanically ventilated postoperative high-risk patients who are admitted to intensive care

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • moribund patient
  • non-curative care (comfort care)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Intensive Care Patients

    Postoperative high-risk patients who have been admitted to intensive care after surgery

  • Operative Control patients

    Elective operative patients where control blood samples and muscle ultrasound will be measured.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: a median of 14 days

Secondary outcomes

  1. 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.

    Time frame: a median of 14 days

  2. 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.

    Time frame: a median of 14 days

Other outcomes

  1. 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.

    Time frame: a median of 14 days

  2. 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.

    Time frame: a median of 14 days

07

Study locations

1 of 3 sites recruiting
  • Medical University of Vienna
    Vienna, State of Vienna 1090, Austria
    Recruiting
  • Klinikum rechts der Isar, School of Medicine, Technical University of Munich
    Munich, Bavaria 81675, Germany
    Active, not recruiting

    Not enrolling at this site.

  • Charité - Universitätsmedizin Berlin
    Berlin, State of Berlin 10117, Germany
    Active, not recruiting

    Not enrolling at this site.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03810768
Collaborators
Helmholtz Zentrum München, Charite University, Berlin, Germany, Medical University of Vienna
Responsible party
Prof. Dr. Stefan Schaller, MD (Principal Investigator, Medical University of Vienna) — Principal investigator
First posted
Jan 22, 2019
Start date
Sep 2, 2022
Primary completion
Nov 1, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Mar 3, 2026

Study contacts

Stefan J Schaller, MD
Contact
stefan.schaller@meduniwien.ac.at
+4314040041020
Marian Demitsch
Contact
aai-research@muv.ac.at
+4314040041020
Stefan J Schaller, MD
principal investigator · Technical University of Munich
Hennig Wackerhage, PhD
principal investigator · Technical University of Munich

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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