Metabolomics Study on Intensive Care Acquired Muscle Weakness in Polytrauma (MIRACLE II)

Metabolomics Pilot Study on Intensive Care Acquired Muscle Weakness in Polytrauma (MIRACLE-II Study)

In this mono-center pilot trial, polytrauma patients admitted to intensive care will be included. Investigators 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: Completed
• Conditions: Critical Illness; Muscle Weakness; Critical Illness Myopathy; Critical Care; Critical Illness Polyneuropathy; Metabolomics; Intensive Care (ICU) Myopathy

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 81675
      • Klinikum rechts der Isar, School of Medicine, Technical University of Munich

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

polytrauma patients who are admitted to intensive care

Description

Inclusion Criteria:

• acute polytrauma patient
• age ≥ 18 years old
• expected intensive care stay ≥ 3 days
• American Society of Anesthesiologists classification I or II

Exclusion Criteria:

• patient had received cardiopulmonary resuscitation
• limitation of therapy or comfort care

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Intensive Care Patients; Polytrauma patients who have been admitted to intensive care

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 changes in the blood metabolome during muscle wasting (i.e. Intensive Care Unit Acquired Weakness) 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 changes in the muscular structure 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 muscular changes (i.e. 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 at ICU admission	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: Helmholtz Zentrum München
• Investigators: Principal Investigator: Stefan J Schaller, MD, MHBA, Technical University of Munich

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2019
• Primary Completion (Actual): April 22, 2020
• Study Completion (Actual): April 22, 2020

Study Registration Dates

• First Submitted: January 19, 2019
• First Submitted That Met QC Criteria: January 24, 2019
• First Posted (Actual): January 29, 2019

Study Record Updates

• Last Update Posted (Actual): October 6, 2020
• Last Update Submitted That Met QC Criteria: October 4, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Muscle Biopsy; Pilot Trial; Blood Metabolome
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Disease Attributes; Musculoskeletal Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuromuscular Manifestations; Muscle Weakness; Critical Illness; Multiple Trauma; Polyneuropathies; Muscular Diseases; Paresis; Asthenia
• Other Study ID Numbers: MIRACLE II

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