Metabolomics Study on Postoperative Intensive Care Acquired Muscle Weakness

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03810768

Acronym

MIRACLE I

Enrollment

Registered

2019-01-22

Start date

2022-09-02

Completion date

2026-12-31

Last updated

2026-03-03

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, 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

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 influence of Intensive Care Unit Acquired Weakness (ICUAW) 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 influence of Intensive Care Unit Acquired Weakness (ICUAW) 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 Intensive Care Unit Acquired Weakness (ICUAW) and correlation with blood metabolome changes.

Countries

Austria, Germany

Contacts

CONTACTStefan J Schaller, MD

stefan.schaller@meduniwien.ac.at+4314040041020

CONTACTMarian Demitsch

aai-research@muv.ac.at+4314040041020

PRINCIPAL_INVESTIGATORStefan J Schaller, MD

Technical University of Munich

PRINCIPAL_INVESTIGATORHennig Wackerhage, PhD