NCT07761481

Brief Summary

The goal of this observational study is to evaluate the association between computed tomography-determined sarcopenia and muscle quality impairment with 28-day mortality in adult patients (aged 18 and older) with solid or hematologic malignancies admitted to the Intensive Care Unit (ICU). The main question it aims to answer is: Is lower psoas muscle quality, calculated using the Hounsfield Unit Average Calculation (HUAC), associated with increased 28-day mortality in critically ill cancer patients? Researchers will compare patients who survived at 28 days with those who died to evaluate whether tomographic muscle measurements (HUAC and total psoas area) and clinical nutritional scores (mNUTRIC) differ between groups and predict mortality. Participants' records will be evaluated through:

  • A retrospective review of electronic medical records to collect demographic, clinical, oncologic, laboratory, and disease severity scores (APACHE II, SOFA, mNUTRIC).
  • Quantitative tomographic assessment of the right and left psoas muscle area and radiation attenuation density (in Hounsfield Units) using existing computed tomography (CT) scans performed during routine clinical care.
  • Follow-up of 28-day vital status (alive or deceased) after ICU admission.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

July 10, 2026

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 12, 2026

Completed
Last Updated

August 12, 2026

Status Verified

August 1, 2026

Enrollment Period

26 days

First QC Date

August 5, 2026

Last Update Submit

August 10, 2026

Conditions

Keywords

SarcopeniaCritically ill cancer patientComputed tomographyMortality

Outcome Measures

Primary Outcomes (1)

  • 28-Day All-Cause Mortality

    Vital status (alive or deceased) of critically ill cancer patients evaluated at 28 days following their admission to the Intensive Care Unit (ICU). The association with muscle quality metrics, specifically the Hounsfield Unit Average Calculation (HUAC) of the psoas muscles obtained via computed tomography (CT) scan, will be assessed.

    At 28 days post-ICU admission

Secondary Outcomes (4)

  • Nutritional Risk Assessment via mNUTRIC Score

    Baseline (at ICU admission)

  • Total Psoas Muscle Cross-Sectional Area

    Baseline (CT scans performed within routine care prior to or at ICU admission)

  • Acute Physiology and Chronic Health Evaluation II (APACHE II) Score

    At ICU admission (Baseline)

  • Sequential Organ Failure Assessment (SOFA) Score

    Baseline (at ICU admission)

Study Arms (2)

Survivors

Critically ill cancer patients admitted to the ICU who survived at 28 days post-admission.

Other: Computed Tomography Muscle Assessment (HUAC)

Non survivors

Critically ill cancer patients admitted to the ICU who died within 28 days post-admission

Other: Computed Tomography Muscle Assessment (HUAC)

Interventions

Quantitative measurement of cross-sectional area and radiological density (Hounsfield Units) of the bilateral psoas muscles on abdominal CT scans obtained during routine care to calculate the Hounsfield Unit Average Calculation (HUAC).

Non survivorsSurvivors

Eligibility Criteria

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

Critically ill adult cancer patients (with solid or hematological malignancies) admitted to the Intensive Care Unit (ICU) at Hospital H+ Querétaro between January 2022 and December 2025 who underwent abdominal CT scans during routine clinical management

You may qualify if:

  • Adult patients aged 18 years or older.
  • Confirmed diagnosis of solid or hematological malignancy.
  • Admitted to the Intensive Care Unit (ICU) between January 1, 2022, and December 31, 2025.
  • Availability of an abdominal computed tomography (CT) scan performed during routine clinical care at the time of or prior to ICU admission.

You may not qualify if:

  • Missing or incomplete clinical, laboratory, or outcome data in the electronic medical record.
  • Non-evaluable abdominal CT scans due to motion artifacts, metal artifacts, or lack of cross-sectional visibility of the bilateral psoas muscles.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital H+ Querétaro, Santiago de Querétaro, Querétaro

Querétaro City, Querétaro, 76030, Mexico

Location

MeSH Terms

Conditions

SarcopeniaNeoplasmsCritical IllnessMalnutrition

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsDisease AttributesPathologic ProcessesNutrition DisordersNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 5, 2026

First Posted

August 12, 2026

Study Start

July 10, 2026

Primary Completion

August 5, 2026

Study Completion

August 5, 2026

Last Updated

August 12, 2026

Record last verified: 2026-08

Locations