MetabolomicsMIRACLE IINCT03819959
Metabolomics Study on Intensive Care Acquired Muscle Weakness in Polytrauma
An observational study of Metabolomics and Critical Care, run by Technical University of Munich at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolomics, Critical Care, Critical Illness
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- 24 Mar 2019to 22 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: polytrauma patients who are admitted to intensive care
Who may be able to join
- acute polytrauma patient
- age ≥ 18 years old
- expected intensive care stay ≥ 3 days
- American Society of Anesthesiologists classification I or II
Who cannot join
- patient had received cardiopulmonary resuscitation
- limitation of therapy or comfort care
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinikum rechts der Isar, School of Medicine, Technical University of Munich
Munich, Bavaria, 81675
About this study
Official title: 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.
- Conditions
- Metabolomics, Critical Care, Critical Illness, Critical Illness Myopathy, Critical Illness Polyneuropathy, Intensive Care (ICU) Myopathy
- Keywords
- Pilot Trial, Muscle Biopsy, Blood Metabolome
- Medical subject headings
- Critical Illness, Polyneuropathies, Muscular Diseases, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Intensive Care Patients | Polytrauma patients who have been admitted to intensive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: a median of 14 days
Secondary outcomes (2)
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.
Measured: 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.
Measured: a median of 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start24 Mar 2019
- Primary completion22 Apr 2020
- Study completion22 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MetabolomicsStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Helmholtz Zentrum München
- Responsible party
- Principal investigator, Stefan Schaller, Technical University of Munich
- Investigators
- Stefan J Schaller, MD, MHBA, Principal investigator, Technical University of MunichHennig Wackerhage, PhD, Principal investigator, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03819959
- Sponsor's protocol ID
- MIRACLE II
- Acronym
- MIRACLE II
- Status last verified
- Oct 2020
- First submitted
- 19 Jan 2019
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolomics Pilot Study on Intensive Care Acquired Muscle Weakness in Polytrauma (MIRACLE-II Study)
- ClinicalTrials.gov ID
- NCT03819959
- Acronym / sponsor ID
- MIRACLE II / MIRACLE II
- Conditions
- Metabolomics, Critical Care, Critical Illness, Critical Illness Myopathy, Critical Illness Polyneuropathy, Intensive Care (ICU) Myopathy
- Keywords
- Pilot Trial, Muscle Biopsy, Blood Metabolome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- Helmholtz Zentrum München
- Study start
- 24 Mar 2019 (actual)
- Primary completion
- 22 Apr 2020 (actual)
- Study completion
- 22 Apr 2020 (actual)
- First posted
- 29 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intensive Care Patients | – | –Polytrauma patients who have been admitted to intensive care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- polytrauma patients who are admitted to intensive care
Key inclusion criteria (4 listed)
- acute polytrauma patient
- age ≥ 18 years old
- expected intensive care stay ≥ 3 days
- American Society of Anesthesiologists classification I or II
Key exclusion criteria (2 listed)
- patient had received cardiopulmonary resuscitation
- limitation of therapy or comfort care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Metabolomics
Time frame: a median of 14 days
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
2 secondary outcomes
Muscle histology
Time frame: a median of 14 days
Phosphoproteomics
Time frame: a median of 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan J Schaller, MD, MHBA principal investigator
Technical University of Munich
Hennig Wackerhage, PhD principal investigator
Technical University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolomics and Critical Care, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolomics (time frame: a median of 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2020.