Metabolomics Study on Postoperative Intensive Care Acquired Muscle Weakness

NCT03810768 | Recruiting

• 1 other identifier: MIRACLE I
• Study Type: observational
• Target: 20
• Locations: 2 countries
• Sites: 3

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.

Conditions

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

Keywords

pilot trial; muscle biopsy; blood metabolome

Outcome Measures

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.

  a median of 14 days

Secondary Outcomes (2)

• Muscle histology

  a median of 14 days

• Phosphoproteomics

  a median of 14 days

Other Outcomes (2)

• Identify possible predictors of muscle wasting in the blood metabolome preoperatively

  a median of 14 days

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

  a median of 14 days

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Technical University of Munich: lead
• Helmholtz Zentrum München: collaborator
• Charite University, Berlin, Germany: collaborator
• Medical University of Vienna: collaborator

Study Sites (3)

Medical University of Vienna

Vienna, Vienna, 1090, Austria

RECRUITING

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

Munich, Bavaria, 81675, Germany

ACTIVE NOT RECRUITING

Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, 10117, Germany

ACTIVE NOT RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

* Blood * Skeletal muscle biopsy

MeSH Terms

Conditions

Critical Illness; Polyneuropathies; Muscular Diseases; Muscle Weakness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Stefan J Schaller, MD

  Technical University of Munich

  PRINCIPAL INVESTIGATOR

• Hennig Wackerhage, PhD

  Technical University of Munich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan J Schaller, MD

CONTACT

+4314040041020; stefan.schaller@meduniwien.ac.at

Marian Demitsch

CONTACT

+4314040041020; aai-research@muv.ac.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 25, 2018
• First Posted: January 22, 2019
• Study Start: September 2, 2022
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

AU (1); DE (2)