Metabolomics Study on Intensive Care Acquired Muscle Weakness in Polytrauma

NCT03819959 | Completed

• 1 other identifier: MIRACLE II
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Pilot Trial; Muscle Biopsy; Blood Metabolome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Muscle histology

  a median of 14 days

• Phosphoproteomics

  a median of 14 days

Other Outcomes (1)

• Identify possible predictors of muscle wasting in the blood metabolome at ICU admission

  a median of 14 days

Study Arms (1)

Intensive Care Patients

Polytrauma patients who have been admitted to intensive care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

polytrauma patients who are admitted to intensive care

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Technical University of Munich: lead
• Helmholtz Zentrum München: collaborator

Study Sites (1)

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

Munich, Bavaria, 81675, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

* Blood * Skeletal muscle biopsy

MeSH Terms

Conditions

Critical Illness; Polyneuropathies; Muscular Diseases; Muscle Weakness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Stefan J Schaller, MD, MHBA

  Technical University of Munich

  PRINCIPAL INVESTIGATOR

• Hennig Wackerhage, PhD

  Technical University of Munich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 19, 2019
• First Posted: January 29, 2019
• Study Start: March 24, 2019
• Primary Completion: April 22, 2020
• Study Completion: April 22, 2020
• Last Updated: October 6, 2020

Record last verified: 2020-10

Locations

DE (1)