NCT07303335

Brief 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. 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 14, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 24, 2025

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

December 24, 2025

Status Verified

December 1, 2025

Enrollment Period

8 months

First QC Date

November 17, 2025

Last Update Submit

December 18, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline at admission to ICU

Secondary Outcomes (2)

  • Detecting patients who develop ICU-Acquired Weakness (ICU-AW) and/or prolonged mechanical ventilation weaning

    From ICU admission to 30 days follow-up

  • Detecting the appearance of other complications

    From admission to 30 days follow up

Study Arms (1)

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)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to a polyvalent (medical and surgical) ICU.

You may qualify if:

  • Older than 18 years old.
  • Expected duration of mechanical ventilation (MV) exceeding 48 hours.

You may not qualify if:

  • Refusal to participate.
  • Mechanical ventilation not exceeding 48 hours.
  • Do-not-resuscitate (DNR) orders or limitations of therapeutic effort upon admission.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari Mútua Terrassa

Terrassa, Barcelona, 08012, Spain

Location

Related Publications (2)

  • 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.

    PMID: 39549651BACKGROUND
  • 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.

    PMID: 31890223BACKGROUND

MeSH Terms

Conditions

SarcopeniaCritical IllnessMuscular Diseases

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsDisease AttributesPathologic ProcessesMusculoskeletal DiseasesNeuromuscular Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
4 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2025

First Posted

December 24, 2025

Study Start

May 14, 2025

Primary Completion

December 31, 2025

Study Completion

February 1, 2026

Last Updated

December 24, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

All collected IPD

Shared Documents
STUDY PROTOCOL, ICF

Locations