MIRACLE I: Metabolomics Study on Postoperative Intensive Care Acquired Muscle Weakness

Sponsor

Technische Universität München (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT03810768

Collaborator

Helmholtz Zentrum München (Industry), Charite University, Berlin, Germany (Other)

Enrollment

Locations

16.1

Anticipated Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolomics Critical Care Critical Illness Critical Illness Myopathy Critical Illness Polyneuropathy Intensive Care (ICU) Myopathy Muscle Weakness

Study Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Aug 28, 2022

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Intensive Care Patients Postoperative high-risk patients who have been admitted to intensive care after surgery

Outcome Measures

Primary Outcome Measures

Metabolomics [a median of 14 days]
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.

Secondary Outcome Measures

Muscle histology [a median of 14 days]
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.
Phosphoproteomics [a median of 14 days]
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.

Other Outcome Measures

Identify possible predictors of muscle wasting in the blood metabolome preoperatively [a median of 14 days]
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.
Identify possible predictors of muscle wasting in the blood metabolome at ICU admission [a median of 14 days]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Klinikum rechts der Isar, School of Medicine, Technical University of Munich	Munich	Bavaria	Germany	81675
2	Charité - Universitätsmedizin Berlin	Berlin		Germany	10117