Metabolomics Study on Intensive Care Acquired Muscle Weakness in Polytrauma

NCT ID: NCT03819959

Last Updated: 2020-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-24

Study Completion Date

2020-04-22

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Intensive Care Patients

Polytrauma patients who have been admitted to intensive care

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helmholtz Zentrum München

INDUSTRY

Sponsor Role collaborator

Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Stefan Schaller

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stefan J Schaller, MD, MHBA

Role: PRINCIPAL_INVESTIGATOR

Technical University of Munich

Hennig Wackerhage, PhD

Role: PRINCIPAL_INVESTIGATOR

Technical University of Munich

Locations

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

Munich, Bavaria, Germany

Site Status

Countries

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Germany

Other Identifiers

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MIRACLE II

Identifier Type: -

Identifier Source: org_study_id

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