SarcopeniaSARC-ICUNCT07303335
Prevalence of Sarcopenia in Patients Admitted to ICU and Its Progression During Hospitalization.
An observational study of Sarcopenia and Critical Illness, run by Hospital Mutua de Terrassa at 1 site in Spain.
Trial summary
This is a prospective, observational study at the ICU of Hospital Mútua de Terrassa, running from May to December 2025. The primary goal is to determine the prevalence of sarcopenia in adult patients requiring more than 48 hours of mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcopenia, Critical Illness, Intensive Care (ICU) Myopathy
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 14 May 2025to Feb 2026
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients admitted to a polyvalent (medical and surgical) ICU.
Who may be able to join
- Older than 18 years old.
- Expected duration of mechanical ventilation (MV) exceeding 48 hours.
Who cannot join
- Refusal to participate.
- Mechanical ventilation not exceeding 48 hours.
- Do-not-resuscitate (DNR) orders or limitations of therapeutic effort upon admission.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This is a prospective, observational study at the ICU of Hospital Mútua de Terrassa, running from May to December 2025. The primary goal is to determine the prevalence of sarcopenia in adult patients requiring more than 48 hours of mechanical ventilation. Sarcopenia is assessed using the SARC-F score, impedanciometry, and quadriceps ultrasound. Secondary aims include tracking the development of ICU-Acquired Weakness (ICU-AW) using the MRC score. All data is collected anonymously after obtaining informed consent.
- Conditions
- Sarcopenia, Critical Illness, Intensive Care (ICU) Myopathy, Body Composition Measurement, Bio-Impedance Measurements, Ultrasound Evaluation
- Medical subject headings
- Sarcopenia, Critical Illness, Muscular Diseases
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 |
|---|---|---|
| Critically ill adults (medical or surgical) expected to require prolonged mechanical ventilation. | Assesment of the body composition using Rectus Femoris (RF) Ultrasound and Bioelectrical Impedance Analysis (BIA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of sarcopenia at the time of ICU admission.
Describe the prevalence of sarcopenia at the time of ICU admission in patients with an expected duration of mechanical ventilation (MV) exceeding 48 hours.
Measured: Baseline at admission to ICU
Secondary outcomes (2)
Detecting patients who develop ICU-Acquired Weakness (ICU-AW) and/or prolonged mechanical ventilation weaning
Detecting patients who develop ICU-Acquired Weakness (ICU-AW) and/or prolonged mechanical ventilation weaning, defined as failure of definitive disconnection from mechanical ventilation
Measured: From ICU admission to 30 days follow-up
Detecting the appearance of other complications
Detecting the appearance of other complications during admission such as: the appearance of refeeding syndrome or increased prevalence of insulin resistance.
Measured: From admission to 30 days follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start14 May 2025
- Primary completion31 Dec 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies 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
- 100 participants (estimated)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Hospital Mutua de Terrassa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07303335
- Sponsor's protocol ID
- P/25-054/Fundació assistencial
- Other IDs
- Mutua Terrassa
- Acronym
- SARC-ICU
- Status last verified
- Dec 2025
- First submitted
- 17 Nov 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD
Publications
Sostakaite G, Jauniskyte M, Budrys D, Budrevicius K, Salciute-Simene E, Svetikiene M, Jovaisa T, Zvirblis T, Klimasauskas A, Sipylaite J. Comparison of Two Techniques to Assess Muscle Mass Loss During ICU Stay: Muscle Ultrasound vs Bioelectrical Impedance Analysis. Nutrition. 2025 Feb;130:112607. doi: 10.1016/j.nut.2024.112607. Epub 2024 Oct 24.
PubMed 39549651Nakanishi N, Tsutsumi R, Okayama Y, Takashima T, Ueno Y, Itagaki T, Tsutsumi Y, Sakaue H, Oto J. Monitoring of muscle mass in critically ill patients: comparison of ultrasound and two bioelectrical impedance analysis devices. J Intensive Care. 2019 Dec 16;7:61. doi: 10.1186/s40560-019-0416-y. eCollection 2019.
PubMed 31890223
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Sarcopenia in Patients Admitted to ICU and Its Progression During Hospitalization.
- ClinicalTrials.gov ID
- NCT07303335
- Acronym / sponsor ID
- SARC-ICU / P/25-054/Fundació assistencial
- Conditions
- Sarcopenia, Critical Illness, Intensive Care (ICU) Myopathy, Body Composition Measurement, Bio-Impedance Measurements, Ultrasound Evaluation
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital Mutua de TerrassaUniversity, hospital or other
- Study start
- 14 May 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 24 Dec 2025 (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.
This is a prospective, observational study at the ICU of Hospital Mútua de Terrassa, running from May to December 2025. The primary goal is to determine the prevalence of sarcopenia in adult patients requiring more than 48 hours of mechanical ventilation. Sarcopenia is assessed using the SARC-F score, impedanciometry, and quadriceps ultrasound. Secondary aims include tracking the development of ICU-Acquired Weakness (ICU-AW) using the MRC score. All data is collected anonymously after obtaining informed consent.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill adults (medical or surgical) expected to require prolonged mechanical ventilation. | – | –Assesment of the body composition using Rectus Femoris (RF) Ultrasound and Bioelectrical Impedance Analysis (BIA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to a polyvalent (medical and surgical) ICU.
Key inclusion criteria (2 listed)
- Older than 18 years old.
- Expected duration of mechanical ventilation (MV) exceeding 48 hours.
Key exclusion criteria (3 listed)
- Refusal to participate.
- Mechanical ventilation not exceeding 48 hours.
- Do-not-resuscitate (DNR) orders or limitations of therapeutic effort upon admission.
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
Prevalence of sarcopenia at the time of ICU admission.
Time frame: Baseline at admission to ICU
Describe the prevalence of sarcopenia at the time of ICU admission in patients with an expected duration of mechanical ventilation (MV) exceeding 48 hours.
2 secondary outcomes
Detecting patients who develop ICU-Acquired Weakness (ICU-AW) and/or prolonged mechanical ventilation weaning
Time frame: From ICU admission to 30 days follow-up
Detecting the appearance of other complications
Time frame: From admission to 30 days follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Background: PubMed 39549651Sostakaite G, Jauniskyte M, Budrys D, Budrevicius K, Salciute-Simene E, Svetikiene M, Jovaisa T, Zvirblis T, Klimasauskas A, Sipylaite J. Comparison of Two Techniques to Assess Muscle Mass Loss During ICU Stay: Muscle Ultrasound vs Bioelectrical Impedance Analysis. Nutrition. 2025 Feb;130:112607. doi: 10.1016/j.nut.2024.112607. Epub 2024 Oct 24.
- Background: PubMed 31890223Nakanishi N, Tsutsumi R, Okayama Y, Takashima T, Ueno Y, Itagaki T, Tsutsumi Y, Sakaue H, Oto J. Monitoring of muscle mass in critically ill patients: comparison of ultrasound and two bioelectrical impedance analysis devices. J Intensive Care. 2019 Dec 16;7:61. doi: 10.1186/s40560-019-0416-y. eCollection 2019.
- Individual participant dataSharing planned: Yes. All collected IPD
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Sarcopenia and Critical Illness, run by Hospital Mutua de Terrassa at 1 site in Spain.
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 3 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: enrolling by invitation, as of the sponsor's last update on 24 Dec 2025. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
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?
Prevalence of sarcopenia at the time of ICU admission. (time frame: Baseline at admission to ICU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07303335, which also lists 2 linked publications.
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 24 Dec 2025.