Metabolomics Study on Postoperative Intensive Care Acquired Muscle Weakness

NCT ID: NCT03810768

Last Updated: 2025-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-02

Study Completion Date

2026-12-31

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Intensive Care Patients

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

No interventions assigned to this group

Operative Control patients

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

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helmholtz Zentrum München

INDUSTRY

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role collaborator

Medical University of Vienna

OTHER

Sponsor Role collaborator

Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Stefan Schaller, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stefan J Schaller, MD

Role: PRINCIPAL_INVESTIGATOR

Technical University of Munich

Hennig Wackerhage, PhD

Role: PRINCIPAL_INVESTIGATOR

Technical University of Munich

Locations

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Medical University of Vienna

Vienna, Vienna, Austria

Site Status RECRUITING

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

Munich, Bavaria, Germany

Site Status ACTIVE_NOT_RECRUITING

Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, Germany

Site Status RECRUITING

Countries

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Austria Germany

Central Contacts

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Stefan J Schaller, MD

Role: CONTACT

+49-89-4140-9635

Manfred Blobner, MD

Role: CONTACT

+49-89-4140-7206

Facility Contacts

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Stefan J Schaller, MD

Role: primary

+4314040041020

Stefan Study Coordinator

Role: backup

+4314040041020

Stefan J Schaller, MD

Role: primary

+49-30-450-531052

Other Identifiers

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MIRACLE I

Identifier Type: -

Identifier Source: org_study_id

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