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

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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Stefan J Schaller, MD; Phone Number: +4314040041020; Email: stefan.schaller@meduniwien.ac.at
• Study Contact Backup: Name: Marian Demitsch; Phone Number: +4314040041020; Email: aai-research@muv.ac.at

Study Locations

• Austria
  • Vienna
    • Vienna, Vienna, Austria, 1090
      • Recruiting
      • Medical University of Vienna
      • Principal Investigator: Stefan J Schaller, MD
      • Contact: Stefan J Schaller, MD; Phone Number: +4314040041020; Email: stefan.schaller@meduniwien.ac.at
      • Contact: Stefan Study Coordinator; Phone Number: +4314040041020; Email: aai-research@meduniwien.ac.at
• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 81675
      • Active, not recruiting
      • Klinikum rechts der Isar, School of Medicine, Technical University of Munich
  • State of Berlin
    • Berlin, State of Berlin, Germany, 10117
      • Active, not recruiting
      • Charité - Universitätsmedizin Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle histology	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.	a median of 14 days
Phosphoproteomics	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.	a median of 14 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identify possible predictors of muscle wasting in the blood metabolome preoperatively	Among the blood metabolome that will be measured, identify metabolites or combinations of metabolites whose high or low concentration(s) preoperatively associate(s) with the amount of muscle loss. These metabolites are candidate biomarkers that could be used to identify individuals at risk of large muscle wasting and may give further insights into the mechanisms of muscle wasting.	a median of 14 days
Identify possible predictors of muscle wasting in the blood metabolome at ICU admission	Among the blood metabolome that will be measured, identify metabolites or combinations of metabolites whose high or low concentration(s) at ICU admission associate(s) with the amount of muscle loss. These metabolites are candidate biomarkers that could be used to identify individuals at risk of large muscle wasting and may give further insights into the mechanisms of muscle wasting.	a median of 14 days

Collaborators and Investigators

• Sponsor: Technical University of Munich
• Collaborators: Medical University of Vienna; Charite University, Berlin, Germany; Helmholtz Zentrum München
• Investigators: Principal Investigator: Stefan J Schaller, MD, Technical University of Munich; Principal Investigator: Hennig Wackerhage, PhD, Technical University of Munich

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2022
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 25, 2018
• First Submitted That Met QC Criteria: January 16, 2019
• First Posted (Actual): January 22, 2019

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 28, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: pilot trial; muscle biopsy; blood metabolome
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Neuromuscular Manifestations; Pathologic Processes; Neuromuscular Diseases; Disease Attributes; Peripheral Nervous System Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Critical Illness; Polyneuropathies; Muscle Weakness; Muscular Diseases
• Other Study ID Numbers: MIRACLE I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No