We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03810768
Recruitment Status : Recruiting
First Posted : January 22, 2019
Last Update Posted : September 21, 2022
Sponsor:
Collaborators:
Helmholtz Zentrum München
Charite University, Berlin, Germany
Information provided by (Responsible Party):
Stefan Schaller, Technical University of Munich

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

Layout table for study information
Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Metabolomics Pilot Study on Postoperative Intensive Care Acquired Muscle Weakness (MIRACLE-I Study)
Actual Study Start Date : September 2, 2022
Estimated Primary Completion Date : November 1, 2023
Estimated Study Completion Date : December 31, 2023

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.



Primary Outcome Measures :
  1. Metabolomics [ Time Frame: 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 :
  1. Muscle histology [ Time Frame: 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.

  2. Phosphoproteomics [ Time Frame: 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:
  1. Identify possible predictors of muscle wasting in the blood metabolome preoperatively [ Time Frame: 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.

  2. Identify possible predictors of muscle wasting in the blood metabolome at ICU admission [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA
  • Blood
  • Skeletal muscle biopsy


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
mechanically ventilated postoperative high-risk patients who are admitted to intensive care
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03810768


Contacts
Layout table for location contacts
Contact: Stefan J Schaller, MD +49-89-4140-9635 s.schaller@tum.de
Contact: Manfred Blobner, MD +49-89-4140-7206 m.blobner@tum.de

Locations
Layout table for location information
Germany
Klinikum rechts der Isar, School of Medicine, Technical University of Munich Not yet recruiting
Munich, Bavaria, Germany, 81675
Contact: Stefan J Schaller, MD    +49-89-4140-9635    s.schaller@tum.de   
Contact: Manfred Blobner, MD    +49-89-4140-7206    m.blobner@tum.de   
Principal Investigator: Stefan J Schaller, MD         
Principal Investigator: Henning Wackerhage, PhD         
Sub-Investigator: Manfred Blobner, MD         
Sub-Investigator: Jürgen Schlegel, MD         
Sub-Investigator: Kristina Fuest, MD         
Charité - Universitätsmedizin Berlin Recruiting
Berlin, Germany, 10117
Contact: Stefan J Schaller, MD    +49-30-450-531052    stefan.schaller@charite.de   
Sponsors and Collaborators
Technical University of Munich
Helmholtz Zentrum München
Charite University, Berlin, Germany
Investigators
Layout table for investigator information
Principal Investigator: Stefan J Schaller, MD Technical University of Munich
Principal Investigator: Hennig Wackerhage, PhD Technical University of Munich
Layout table for additonal information
Responsible Party: Stefan Schaller, Principal Investigator, Technical University of Munich
ClinicalTrials.gov Identifier: NCT03810768    
Other Study ID Numbers: MIRACLE I
First Posted: January 22, 2019    Key Record Dates
Last Update Posted: September 21, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stefan Schaller, Technical University of Munich:
pilot trial
muscle biopsy
blood metabolome
Additional relevant MeSH terms:
Layout table for MeSH terms
Muscular Diseases
Muscle Weakness
Polyneuropathies
Paresis
Critical Illness
Asthenia
Disease Attributes
Pathologic Processes
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Manifestations
Neurologic Manifestations