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NCT Number: NCT07761481

CT-Determined Sarcopenia and Mortality in Critically Ill Cancer Patients

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.

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Key information

Conditions

Sarcopenia Atrophy Cancer Critical Illness Disease Attributes Malnutrition Muscular Atrophy Neoplasms Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital H+ Querétaro, Santiago de Querétaro, Querétaro

Querétaro City, Querétaro, 76030, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Computed Tomography Muscle Assessment (HUAC)

Other

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).

Primary outcomes

  1. 28-Day All-Cause Mortality

    Time frame: At 28 days post-ICU admission

    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.

Secondary outcomes

  1. Nutritional Risk Assessment via mNUTRIC Score

    Time frame: Baseline (at ICU admission)

    Evaluation of nutritional risk upon ICU admission using the modified Nutrition Risk in Critically Ill (mNUTRIC) score. The score ranges from 0 to 9 points, where 0 represents the lowest nutritional risk and 9 represents the highest nutritional risk (higher scores indicate a worse outcome/higher nutritional risk; a score > 5 indicates high nutritional risk).

  2. Total Psoas Muscle Cross-Sectional Area

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

    Quantitative measurement of the total cross-sectional area of the right and left psoas muscles combined (mm^2 or cm^2) derived from abdominal computed tomography (CT) scans to assess muscle mass quantity.

  3. Acute Physiology and Chronic Health Evaluation II (APACHE II) Score

    Time frame: At ICU admission (Baseline)

    Assessment of clinical disease severity at ICU admission using the Acute Physiology and Chronic Health Evaluation II (APACHE II) score. The score ranges from 0 to 71 points, where 0 indicates no physiological impairment and 71 represents the most severe degree of illness (higher scores indicate greater disease severity and a higher risk of mortality).

  4. Sequential Organ Failure Assessment (SOFA) Score

    Time frame: Baseline (at ICU admission)

    Assessment of organ dysfunction at ICU admission using the Sequential Organ Failure Assessment (SOFA) score. The score ranges from 0 to 24 points, where 0 indicates normal organ function and 24 represents severe multi-organ failure (higher scores indicate greater organ dysfunction and worse prognosis).

Sponsors and collaborators

Lead sponsor

Hospital H+ Queretaro

Other

Registry information

Official study title

Association Between Computed Tomography-Determined Sarcopenia and 28-Day Mortality in Critically Ill Cancer Patients: An Analytical Observational Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 12, 2026
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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