Actively Recruiting

Age: 18Years +
All Genders
ID03810768

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

Led by Technical University of Munich · Updated on 2026-03-03

20

Participants Needed

3

Research Sites

8 weeks

Total Duration

On this page

Sponsors

T

Technical University of Munich

Lead Sponsor

H

Helmholtz Zentrum München

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating muscle weakness acquired in intensive care units (ICUAW) among surgical patients at high risk of ICU admission. This pilot study aims to examine changes in the blood metabolome and identify metabolic markers related to ICUAW. The study focuses on understanding metabolic and molecular factors associated with muscle weakness after critical illness and surgery. The study involves two groups: postoperative high-risk patients admitted to intensive care and elective surgery patients serving as controls. Blood and muscle samples will be collected at specific times to perform metabolic, histological, and molecular tests. These tests include metabolomics, muscle tissue analysis, and phosphoproteomics, centered around a median of 14 days after surgery or ICU admission. Participants will undergo blood and muscle sample collections along with muscle ultrasounds in the control group. The research team will monitor metabolic changes and muscle health over about two weeks. The main outcome is the metabolomics profile, with secondary outcomes including muscle tissue structure and protein phosphorylation. The study is conducted at a single center and sponsored by the Technical University of Munich, with a total participation period based on ICU stay and postoperative monitoring.

CONDITIONS

Brief Title

Metabolomics Study on Postoperative Intensive Care Acquired Muscle Weakness

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Invasive mechanically ventilated critically ill patient with expected intensive care unit stay > 3 days
  • Postoperative patient
  • 18 years or older
  • American Society of Anesthesiology (ASA) classification 3 or higher
Not Eligible

You will not qualify if you...

  • Moribund patient
  • Receiving non-curative care (comfort care)

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Monitoring

Duration - Approximately 14 days

Participants are observed during their postoperative intensive care stay with blood samples and muscle ultrasound measurements taken.

Visits aligned with intensive care stay for up to 14 days

Trial Site Locations

Total: 3 locations

1

Medical University of Vienna

Vienna, State of Vienna, Austria, 1090

Actively Recruiting

2

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

Munich, Bavaria, Germany, 81675

Active, Not Recruiting

3

Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, Germany, 10117

Active, Not Recruiting

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Research Team

S

Stefan J Schaller, MD

M

Marian Demitsch

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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