ShockMETASHOCKNCT06285513
Cardiovascular Metabolic Remodeling in Shock
An observational study of Shock, run by University Hospital, Rouen at 1 site in France.
Trial summary
The aim of the study is to increase our knowledge of energy dysfunction in the cardiovascular dysfunction observed during shock states by analysing the omics molecules involved. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Shock
- What is being tested?
- Cardiac ultrasound
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2024to Feb 2026
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalised in intensive care for shock, treated with a vasoactive or ionotropic amine, undergoing invasive mechanical ventilation for less than 24 hours
Who may be able to join
- Patient aged between 18 and 75.
- Patient admitted to intensive care for shock treated with a vasoactive or inotropic amine (adrenaline, dobutamine or noradrenaline).Patient undergoing invasive mechanical ventilation for less than 24 hours (or admitted to intensive care for less than 24 hours if the patient arrived intubated) and for a foreseeable duration of ventilation of at least 48 hours.
- Patient, or relative if the patient is not competent, who has read and understood the information letter and does not object to participation in the research, or emergency procedure in the absence of a relative.
- Urine or blood pregnancy test if a sample is taken as part of routine negative care (if woman of childbearing age).
Who cannot join
- Moribund patient (death expected within < 24 hours) and/or decision to limit or stop treatment on admission to intensive care.
- Pregnant, parturient or breast-feeding woman.
- Patient not suitable for enteral calorie intake. Patient with a history of: advanced chronic renal failure ; advanced chronic liver failure.
- Incapacitated patient of full age (under guardianship, curatorship) or deprived of liberty by court order.
- Patient already taking part in an interventional study.
Trial locations and contacts
1 site in 1 country.
Zoe DEMAILLY, MD contact
About this study
Official title: Metabolic Remodeling Assessment During Severe Cardiovascular Dysfunction in Shock
The aim of the study is to increase our knowledge of energy dysfunction in the cardiovascular dysfunction observed during shock states by analysing the omics molecules involved.
Read the detailed description
To do this, the investigators chose to carry out an in-depth study of the different metabolic pathways, using metabolomic analysis of plasma, targeting the cardiovascular metabolism of patients admitted to intensive care for septic and non-septic shocks.
- Conditions
- Shock
- Being tested
- Cardiac ultrasound
- Keywords
- Metabolic remodelling, Shock states, Cardiovascular dysfunction, Metabolomics
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac ultrasoundDiagnostic test
Also called GlycoCheck, Indirect calorimetry (in case of artificial ventilation)
Cardiac ultrasound : determination of impairment of cardiac function by echocardiographic analysis (at V1, V3 and V4), Glycocheck : automatic analysis of sublingual microcirculation, Indirect calorimetry : determining the increase in energy expenditure in patients with septic shock
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the prognostic capacity of the initial metabolomic profile of patients in shock
Correlation between plasma concentrations of metabolites at inclusion and delta of SOFA score (SOFA Day 1 - SOFA Day 3) with adjustment for SOFA at Day 1
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study startSep 2024 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShockStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Grégoire JOLLY, MD, Principal investigator, University Hospital of Rouen, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06285513
- Sponsor's protocol ID
- 2021/387/OB
- Other IDs
- 2023-A00503-42
- Acronym
- METASHOCK
- Status last verified
- Dec 2023
- First submitted
- 2 Jan 2024
- Last updated
- 10 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Remodeling Assessment During Severe Cardiovascular Dysfunction in Shock
- ClinicalTrials.gov ID
- NCT06285513
- Acronym / sponsor ID
- METASHOCK / 2021/387/OB
- Conditions
- Shock
- Keywords
- Metabolic remodelling, Shock states, Cardiovascular dysfunction, Metabolomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 29 Feb 2024 (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.
The aim of the study is to increase our knowledge of energy dysfunction in the cardiovascular dysfunction observed during shock states by analysing the omics molecules involved.
Detailed description
To do this, the investigators chose to carry out an in-depth study of the different metabolic pathways, using metabolomic analysis of plasma, targeting the cardiovascular metabolism of patients admitted to intensive care for septic and non-septic shocks.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalised in intensive care for shock, treated with a vasoactive or ionotropic amine, undergoing invasive mechanical ventilation for less than 24 hours
Key inclusion criteria (4 listed)
- Patient aged between 18 and 75.
- Patient admitted to intensive care for shock treated with a vasoactive or inotropic amine (adrenaline, dobutamine or noradrenaline).Patient undergoing invasive mechanical ventilation for less than 24 hours (or admitted to intensive care for less than 24 hours if the patient arrived intubated) and for a foreseeable duration of ventilation of at least 48 hours.
- Patient, or relative if the patient is not competent, who has read and understood the information letter and does not object to participation in the research, or emergency procedure in the absence of a relative.
- Urine or blood pregnancy test if a sample is taken as part of routine negative care (if woman of childbearing age).
Key exclusion criteria (5 listed)
- Moribund patient (death expected within < 24 hours) and/or decision to limit or stop treatment on admission to intensive care.
- Pregnant, parturient or breast-feeding woman.
- Patient not suitable for enteral calorie intake. Patient with a history of: advanced chronic renal failure ; advanced chronic liver failure.
- Incapacitated patient of full age (under guardianship, curatorship) or deprived of liberty by court order.
- Patient already taking part in an interventional study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac ultrasoundAlso: GlycoCheck, Indirect calorimetry (in case of artificial ventilation)Cardiac ultrasound : determination of impairment of cardiac function by echocardiographic analysis (at V1, V3 and V4), Glycocheck : automatic analysis of sublingual microcirculation, Indirect calorimetry : determining the increase in energy expenditure in patients with septic shock | Diagnostic test | – |
Primary outcome
Evaluation of the prognostic capacity of the initial metabolomic profile of patients in shock
Time frame: Day 3
Correlation between plasma concentrations of metabolites at inclusion and delta of SOFA score (SOFA Day 1 - SOFA Day 3) with adjustment for SOFA at Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Shock
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CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial
Trauma, Hemorrhage
RecruitingPhase 3
A Trial of Adjunctive Fludrocortisone (50mcg, 100mcg or Placebo) in Critically Ill Patients With Septic Shock Receiving Hydrocortisone, Evaluating Survival and Functional Recovery and the Influence of Transcriptomic Response
Septic Shock
RecruitingObservational study
Physiological Finding in Management of COVID 19 Patients
COVID-19 (Coronavirus Disease 2019)
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.
Zoe DEMAILLY, MD contact
Grégoire JOLLY, MD principal investigator
University Hospital of Rouen, France
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 Shock, run by University Hospital, Rouen at 1 site in France.
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 5 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: status not confirmed, as of the sponsor's last update on 10 Jun 2024. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Grégoire JOLLY, MD (02 32 88 24 50 ext. +33, Gregoire.Jolly@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the prognostic capacity of the initial metabolomic profile of patients in shock (time frame: Day 3). 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 10 Jun 2024.