- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07303335
Prevalence of Sarcopenia in Patients Admitted to ICU and Its Progression During Hospitalization. (SARC-ICU)
December 18, 2025 updated by: Hospital Mutua de Terrassa
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 Overview
Status
Enrolling by invitation
Study Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Barcelona
-
Terrassa, Barcelona, Spain, 08012
- Hospital Universitari Mutua Terrassa
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients admitted to a polyvalent (medical and surgical) ICU.
Description
Inclusion Criteria:
- Older than 18 years old.
- Expected duration of mechanical ventilation (MV) exceeding 48 hours.
Exclusion Criteria:
- Refusal to participate.
- Mechanical ventilation not exceeding 48 hours.
- Do-not-resuscitate (DNR) orders or limitations of therapeutic effort upon admission.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline at admission to ICU
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 patients who develop ICU-Acquired Weakness (ICU-AW) and/or prolonged mechanical ventilation weaning, defined as failure of definitive disconnection from mechanical ventilation
|
From ICU admission to 30 days follow-up
|
|
Detecting the appearance of other complications
Time Frame: From admission to 30 days follow up
|
Detecting the appearance of other complications during admission such as: the appearance of refeeding syndrome or increased prevalence of insulin resistance.
|
From admission to 30 days follow up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Nakanishi 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 14, 2025
Primary Completion (Estimated)
December 31, 2025
Study Completion (Estimated)
February 1, 2026
Study Registration Dates
First Submitted
November 17, 2025
First Submitted That Met QC Criteria
December 18, 2025
First Posted (Actual)
December 24, 2025
Study Record Updates
Last Update Posted (Actual)
December 24, 2025
Last Update Submitted That Met QC Criteria
December 18, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Musculoskeletal Diseases
- Nervous System Diseases
- Neuromuscular Manifestations
- Pathologic Processes
- Pathological Conditions, Anatomical
- Neuromuscular Diseases
- Disease Attributes
- Muscular Atrophy
- Atrophy
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Critical Illness
- Muscular Diseases
- Sarcopenia
Other Study ID Numbers
- P/25-054/Fundació assistencial
- Mutua Terrassa (Other Identifier: Fundació Assistencial Mutua Terrassa)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
All collected IPD
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Critical Illness
-
Duke UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...Not yet recruitingDecision Making | Neonatal Critical Illness | Pediatric Critical IllnessUnited States
-
Duke UniversityNational Institute of Neurological Disorders and Stroke (NINDS); National Institutes...CompletedNeonatal Critical Illness | Pediatric Critical IllnessUnited States
-
Istituto Clinico HumanitasRecruitingCritical Illness Myopathy | Critical Illness Polyneuropathy | Critical Illness PolyneuromyopathyItaly
-
Yale UniversityNational Institute on Aging (NIA)RecruitingCritical Illness | Illness, CriticalUnited States
-
McMaster UniversityLondon Health Sciences Centre; McMaster Children's Hospital; Canadian Critical...CompletedPediatric Critical IllnessCanada
-
Assistance Publique - Hôpitaux de ParisEuropean Society of Intensive Care Medicine; French Society for Intensive Care and other collaboratorsRecruitingCritical Illness | Intensive Care Patients | Critical Illness Requiring Intensive Care - Sepsis | Critical Illness Requiring Intensive Care - Acute Brain Injury | Critical Illness Requiring Intensive Care - Major Surgery | Critical Illness Requiring Intensive Care - PolytraumaFrance
-
Boston Children's HospitalCompleted
-
Istanbul Medeniyet UniversityRecruiting
-
St Helens & Knowsley Teaching Hospitals NHS TrustManchester University NHS Foundation TrustCompleted
-
Karolinska InstitutetNot yet recruitingPediatric Critical IllnessSweden