Metabolomics Study on Postoperative Intensive Care Acquired Muscle Weakness

Recruiting

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

• Registration Number: NCT03810768
• Lead Sponsor: Technical University of Munich

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-25
• Study First Submitted QC: 2019-01-16
• Study First Posted: 2019-01-22
• Study Start: 2022-09-02
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13
• Primary Completion: 2026-11-01
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (3)

Medical University of Vienna; 🇦🇹 Vienna, Austria

Klinikum rechts der Isar, School of Medicine, Technical University of Munich; 🇩🇪 Munich, Bavaria, Germany

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany