Critical CareNCT05115734
Acylcarnitine Profile After Intensive Care
An observational study of Critical Care and Carnitine Metabolism Disturbances, run by University of Liege at 1 site in Belgium.
Trial summary
The aim of the study is to compare the acylcarnitine profile of critically ill survivors of a prolonged stay in ICU with the profile of survivors of short ICU length of stay. The second aim is to assess the evolution of the acylcarnitine profile over time in survivors of a prolonged ICU stay. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Care, Carnitine Metabolism Disturbances
- What is being tested?
- Serum acylcarnitine profiling
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 3 Nov 2021to 1 Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Group short stayers: Critically ill patients with ICU length of stay of 2 days: patients admitted in ICU after a scheduled cardiac surgery with sternotomy * Group long stayers: Critically ill patients with ICU length of stay of at least 7 days, whatever the critically illness
Who may be able to join
- Group short stayers: ICU length of stay of 2 days
- Group long stayers: ICU length of stay of at least 7 days
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
François Boemer, PhD contact
Belgium1 site, 1 recruiting
- Recruiting
University Hospital of Liège
Liège, 4000
Anne-Françoise Rousseau, PhD, +3243667495, afrousseau@chuliege.be
About this study
The aim of the study is to compare the acylcarnitine profile of critically ill survivors of a prolonged stay in ICU with the profile of survivors of short ICU length of stay. The second aim is to assess the evolution of the acylcarnitine profile over time in survivors of a prolonged ICU stay.
Read the detailed description
In a retrospective analysis focused on survivors of an ICU stay of 7 days or more, we showed that during the week following discharge, carnitine deficiency was rare, but acylcarnitine profile was altered, with an abnormal acylcarnitine/carnitine ratio in more than 25% of the population.
Carnitine has a key role in cellular energy metabolism and is a a biomarker of the mitochondria function. Moreover, mitochondrial function is proven to be severely impaired in critically ill patients and mitochondrial dysfunction has been linked to post-ICU disorders.
In this context, it is relevant to study the evolution over time of the acylcarnitine profile in ICU survivors of a prolonged ICU stay. It is also relevant to compare the same profile between survivors of a prolonged and a shorter ICU stay.
- Conditions
- Critical Care, Carnitine Metabolism Disturbances
- Being tested
- Serum acylcarnitine profiling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum acylcarnitine profilingDiagnostic test
Blood samples are collected through a central or peripheral venous line placed for clinical use, or through venous punction. Blood will be drawn into a serum gel tube (BD Vacutainer, Becton, Dickinson and Company, Franklin Lakes, NJ, USA), before being centrifuged (3500 rpm, 15 min, 4°C). Supernatant will be frozen at -20°C and stored for later analysis.
Serum ACs concentrations (free carnitine (C0), C2-, C3-, C3DC-, C4-, C4-OH-, C4-DC-, C5-, C5:1-, C5-OH-, C5DC-, C6-, C6-OH-, C6-DC-, C8-, C8:1-, C10-, C10:1-, C10:2-, C12-, C12:1-, C14-, C14:1-, C14:2-, C14-OH-, C16-, C16:1-, C16-OH-, C16-1-OH-, C17-, C18- ,C18:1-, C18:2-, C18-OH-, C18:1-OH-, C18:2-OH-carnitine) will be determined on a TQ5500 tandem mass spectrometer (Sciex, Framingham, MA, USA).
| Study group | Role | What they receive |
|---|---|---|
| Short stayers | Determination of the acylcarnitine profile during the 5 days following discharge of a short stay in ICU (maximum 2 days) Receives: Diagnostic Test: Serum acylcarnitine profiling | |
| Long stayers | Determination of the acylcarnitine profile during the year following discharge of a prolonged stay in ICU (7 days or more) Receives: Diagnostic Test: Serum acylcarnitine profiling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acylcarnitine profile
Serum acylcarnitine profile
Measured: During the 5 first days following ICU discharge
Acylcarnitine profile
Serum acylcarnitine profile in long stayers
Measured: 1 month following ICU discharge
Acylcarnitine profile
Serum acylcarnitine profile in long stayers
Measured: 3 month following ICU discharge
Acylcarnitine profile
Serum acylcarnitine profile in long stayers
Measured: 12 month following ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start3 Nov 2021
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical CareStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne-Françoise Rousseau, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05115734
- Sponsor's protocol ID
- CARNUSI
- Status last verified
- Jun 2023
- First submitted
- 30 Oct 2021
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acylcarnitine Profile After Intensive Care
- ClinicalTrials.gov ID
- NCT05115734
- Acronym / sponsor ID
- CARNUSI
- Conditions
- Critical Care, Carnitine Metabolism Disturbances
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 10 Nov 2021 (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 compare the acylcarnitine profile of critically ill survivors of a prolonged stay in ICU with the profile of survivors of short ICU length of stay. The second aim is to assess the evolution of the acylcarnitine profile over time in survivors of a prolonged ICU stay.
Detailed description
In a retrospective analysis focused on survivors of an ICU stay of 7 days or more, we showed that during the week following discharge, carnitine deficiency was rare, but acylcarnitine profile was altered, with an abnormal acylcarnitine/carnitine ratio in more than 25% of the population.
Carnitine has a key role in cellular energy metabolism and is a a biomarker of the mitochondria function. Moreover, mitochondrial function is proven to be severely impaired in critically ill patients and mitochondrial dysfunction has been linked to post-ICU disorders.
In this context, it is relevant to study the evolution over time of the acylcarnitine profile in ICU survivors of a prolonged ICU stay. It is also relevant to compare the same profile between survivors of a prolonged and a shorter ICU stay.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short stayers | – | Diagnostic Test: Serum acylcarnitine profilingDetermination of the acylcarnitine profile during the 5 days following discharge of a short stay in ICU (maximum 2 days) |
| Long stayers | – | Diagnostic Test: Serum acylcarnitine profilingDetermination of the acylcarnitine profile during the year following discharge of a prolonged stay in ICU (7 days or more) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Group short stayers: Critically ill patients with ICU length of stay of 2 days: patients admitted in ICU after a scheduled cardiac surgery with sternotomy * Group long stayers: Critically ill patients with ICU length of stay of at least 7 days, whatever the critically illness
Key inclusion criteria (2 listed)
- Group short stayers: ICU length of stay of 2 days
- Group long stayers: ICU length of stay of at least 7 days
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Serum acylcarnitine profilingBlood samples are collected through a central or peripheral venous line placed for clinical use, or through venous punction. Blood will be drawn into a serum gel tube (BD Vacutainer, Becton, Dickinson and Company, Franklin Lakes, NJ, USA), before being centrifuged (3500 rpm, 15 min, 4°C). Supernatant will be frozen at -20°C and stored for later analysis. Serum ACs concentrations (free carnitine (C0), C2-, C3-, C3DC-, C4-, C4-OH-, C4-DC-, C5-, C5:1-, C5-OH-, C5DC-, C6-, C6-OH-, C6-DC-, C8-, C8:1-, C10-, C10:1-, C10:2-, C12-, C12:1-, C14-, C14:1-, C14:2-, C14-OH-, C16-, C16:1-, C16-OH-, C16-1-OH-, C17-, C18- ,C18:1-, C18:2-, C18-OH-, C18:1-OH-, C18:2-OH-carnitine) will be determined on a TQ5500 tandem mass spectrometer (Sciex, Framingham, MA, USA). | Diagnostic test | Long stayers, Short stayers |
Primary outcome
Acylcarnitine profile
Time frame: During the 5 first days following ICU discharge
Serum acylcarnitine profile
Acylcarnitine profile
Time frame: 1 month following ICU discharge
Serum acylcarnitine profile in long stayers
Acylcarnitine profile
Time frame: 3 month following ICU discharge
Serum acylcarnitine profile in long stayers
Acylcarnitine profile
Time frame: 12 month following ICU discharge
Serum acylcarnitine profile in long stayers
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Individual participant dataSharing planned: No
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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.
François Boemer, PhD contact
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 Critical Care and Carnitine Metabolism Disturbances, run by University of Liege at 1 site in Belgium.
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 2 inclusion and 0 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 27 Jun 2023. 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 Belgium. 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 Anne-Françoise Rousseau, MD, PhD (+3243667495, afrousseau@chuliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acylcarnitine profile (time frame: During the 5 first days following ICU discharge). The study lists 4 primary outcomes in all. 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 27 Jun 2023.