Muscle LossNCT06728722
Ultrasound Detection of Body Composition in Critical Care
An observational study of Muscle Loss and Extracellular Fluid Alteration, run by Ain Shams University at 1 site in Egypt.
Trial summary
Objective assessment of the Changes in body composition of critically ill patients is very valuable. Ultrasound stands as a solution due to its portability, bedside availability, and radiation-free technology. Those criteria are crucial for critically ill obstetrics and gynecological cases. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Muscle Loss, Extracellular Fluid Alteration, Critical Illness
- What is being tested?
- ultrasound detection of body composition
- Type of treatment
- Injection or infusion
- How many people
- 121 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2024to 1 Dec 2026
- 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 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Critically ill women whether pregnant, peripartum, postoperative, or admitted for any critical illness.
Who may be able to join
- females with age 16 with no upper limit
- American Society of Anesthesiologists (ASA) class I, II or III,
- admitted to the obstetrics and Gynecology critical care unit
Who cannot join
- Patient refusal
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Ain shams university
Cairo, Cairo Governorate, 11528
Anesthesia department, 010009499962, anesth_office@med.asu.edu.eg
About this study
Official title: Detection of the Changes in Body Composition of Critically Ill Obstetrics by Ultrasound and the Co-relations With Clinical Outcomes; a Prospective Observational Study.
Objective assessment of the Changes in body composition of critically ill patients is very valuable. Ultrasound stands as a solution due to its portability, bedside availability, and radiation-free technology. Those criteria are crucial for critically ill obstetrics and gynecological cases.
Read the detailed description
Patients with acute/critical illness are particularly vulnerable to muscle loss and fluid shifts, which adversely impact clinical outcomes. Assessment of these parameters in hospital settings is often subjective and imprecise, which creates discrepancies in identification and difficulty in follow-up.
The decrease in muscle mass and/or change in the composition, and fluid overload adversely impact the clinical outcome in critically ill patients and their recovery. There is growing interest in body composition (BC) assessment techniques that can be applied in ICU settings. whole-body BC estimates, and select BC variables show promise as biomarkers of muscle health, nutrition risk, and fluid status. Studies reported that Quadriceps muscle thickness predicted increased morbidity/mortality in ICU patients and has been suggested to be an objective biomarker to determine fitness for aggressive treatment. US measures of muscle loss in the critically ill will aid in the development of appropriate intervention strategies. Alternatively, qualitative muscle evaluation through the measure of echogenicity (using image gray-scale visual analysis) is a sensitive indicator of muscle atrophy. The ultrasound can contribute to assessing necrosis, fatty infiltration, and inflammation in place of invasive muscle biopsy in critically ill patients. Ultrasound offers an important tool for early non-volitional assessment of muscle function in the critically ill.
US characterization of muscle changes would facilitate the development and monitoring of muscle-targeted nutrition and physical therapy interventions. Knowing body muscle and adipose tissue mass is essential in several clinical situations to adapt drug dose to the volume of distribution and to guide nutrition as well as physical therapy. US imaging is a practical method for the prospective assessment of SM (skeletal muscle) changes in response to illness and treatment. Previous ICU studies have focused on measurements of muscle quantity (muscle thickness and CSA) in both the quadriceps, a muscle region known to be rapidly impacted by sarcopenia, and to correlate with ICU survival. Ultrasound has been used primarily as a tool for body composition measurement in clinical nutrition. Although many recent reports have demonstrated that ultrasound could be a useful tool for nutritional assessment and body composition assessment, it is not well incorporated into ICU practice regarding nutritional assessment and follow-up This trial is the first to investigate the role of ultrasound in detecting body composition in critically ill obstetrics and gynecological cases and its correlation with clinical outcomes.
- Conditions
- Muscle Loss, Extracellular Fluid Alteration, Critical Illness, Pregnancy Complications, Gynecologic Disease
- Being tested
- ultrasound detection of body composition
- Keywords
- ultrasound, body composition, critical illness, peripartum and gynecological cases
- Medical subject headings
- Muscular Atrophy, Critical Illness, Pregnancy Complications, Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound detection of body compositionDiagnostic test
Muscle mass and fat thickness assessed at two representative sites (rectus femoris, biceps brachii) per USVALID (Arabella, 2020). Muscle quality graded via validated 4-point Heckmatt echogenicity scale (Grade 1=normal, Grade 4=severe; full criteria in Outcome Measures).Subcutaneous fat thickness(mm) measured on rectus femoris. FLUID protocol for oedema: 36-site USEG 5-point scale . Day 0, day 2, then every 2 days untill at in-stay deterioration or death or discharge.
| Study group | Role | What they receive |
|---|---|---|
| critically ill obstetrics patients , admitted to ICU | Not described Receives: Diagnostic Test: ultrasound detection of body composition | |
| critically ill gynecological cases, admitted to ICU | Not described Receives: Diagnostic Test: ultrasound detection of body composition |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in body composition-muscular element
Change in muscle thickness (mm) and change in muscle quality, assessed by ultrasound echogenicity at two representative sites: rectus femoris (lower limb) and biceps brachii (upper limb). Muscle quality is graded using the validated four-point Heckmatt scale: Grade 1 = normal echogenicity with distinct bone reflection; Grade 2 = increased echogenicity with preserved architecture and normal bone reflection; Grade 3 = further increased echogenicity with some loss of architecture and reduced bone reflection; Grade 4 = markedly increased echogenicity with total loss of architecture and absent bone reflection. A derived ordinal muscle severity category is calculated from the highest grade observed across the two sites.
Measured: on the day of admission , repeated every 2 days till death or discharge which come first, assessed up to 20 days from admission
change in body composition-fat element
change in thickness of subcutaneous fat measured in mm. A derived categorical adiposity classification (low, normal, or high adipose reserve) is also calculated from this measurement.
Measured: on the day of admission , repeated every 2 days till death or discharge which come first, assessed up to 20 days from admission.
change in body composition-extreacellular oedema element
The examiner will use a 5-point scale of ultrasonic subcutaneous edema grade (USEG) to evaluate subcutaneous edema at each site based on echo intensity, tissue transparency, and fluid properties. The final ultrasonic subcutaneous edema score (USES) is calculated by adding scores from 36 subcutaneous sites (0-144), regionally grouped: hands (0-8), arms (0-16), thoracic wall (0-32), abdominal wall (0-32), thigh (0-24), calves (0-24), feet (0-8), with regional totals averaged to a 0-4 score per region. Lower scores indicate lower oedema severity. A derived categorical oedema severity classification is also calculated from the total score.
Measured: on the day of admission , repeated every 2 days till death or discharge which come first .
Secondary outcomes (1)
co-relation of the change of any elements of body composition with poor outcomes suchs such as death, need for ventilatory or circulatory support or increase the length of stay in icu.
Positive or negative correlation between change in any body composition element (muscular, fat, extracellular oedema) and poor clinical outcomes, measured by frequency of occurrence of poor outcomes in patients with positive change in any element. The muscle, oedema, and adiposity classifications above are combined into a single five-category bedside phenotype (Resilient, Vulnerable, Oedematous, Metabolically Compromised, Extreme Metabolic Risk), assessed at admission and at the point of in-stay deterioration; this composite phenotype is the primary exposure examined against outcome. Poor outcome is defined as a composite of mortality, need for ventilatory support, or need for circulatory support. ICU length of stay is analyzed separately as a continuous outcome. Additional outcomes recorded include failed extubation, need for renal replacement therapy, and need for blood transfusion
Measured: from occurence of change in body composition till the poor outcome. till discharge from icu or death which come first, assessed till 20 days from admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start15 Dec 2024
- Primary completion25 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Muscle LossStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 121 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06728722
- Sponsor's protocol ID
- FMASU R149/2024
- Status last verified
- Sep 2026
- First submitted
- 19 Oct 2024
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Gursoy C, Alkan A, Kaya Cubuk E, Karci E, Yilmaz HO, Cakir T. Rectus abdominis and rectus femoris muscle thickness in determining nutritional risk in critically ill patients: a prospective cohort study in Turkey. BMJ Open. 2023 Mar 30;13(3):e071796. doi: 10.1136/bmjopen-2023-071796.
PubMed 36997242Ponti F, De Cinque A, Fazio N, Napoli A, Guglielmi G, Bazzocchi A. Ultrasound imaging, a stethoscope for body composition assessment. Quant Imaging Med Surg. 2020 Aug;10(8):1699-1722. doi: 10.21037/qims-19-1048.
PubMed 32742962Zhang W, Gu Y, Zhao Y, Lian J, Zeng Q, Wang X, Wu J, Gu Q; Chinese Critical Care Ultrasound Study Group (CCUSG). Focused liquid ultrasonography in dropsy protocol for quantitative assessment of subcutaneous edema. Crit Care. 2023 Mar 18;27(1):114. doi: 10.1186/s13054-023-04403-y.
PubMed 36934293
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of the Changes in Body Composition of Critically Ill Obstetrics by Ultrasound and the Co-relations With Clinical Outcomes; a Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT06728722
- Acronym / sponsor ID
- FMASU R149/2024
- Conditions
- Muscle Loss, Extracellular Fluid Alteration, Critical Illness, Pregnancy Complications, Gynecologic Disease
- Keywords
- ultrasound, body composition, critical illness, peripartum and gynecological cases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 121 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 25 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 11 Dec 2024 (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.
Objective assessment of the Changes in body composition of critically ill patients is very valuable. Ultrasound stands as a solution due to its portability, bedside availability, and radiation-free technology. Those criteria are crucial for critically ill obstetrics and gynecological cases.
Detailed description
Patients with acute/critical illness are particularly vulnerable to muscle loss and fluid shifts, which adversely impact clinical outcomes. Assessment of these parameters in hospital settings is often subjective and imprecise, which creates discrepancies in identification and difficulty in follow-up.
The decrease in muscle mass and/or change in the composition, and fluid overload adversely impact the clinical outcome in critically ill patients and their recovery. There is growing interest in body composition (BC) assessment techniques that can be applied in ICU settings. whole-body BC estimates, and select BC variables show promise as biomarkers of muscle health, nutrition risk, and fluid status. Studies reported that Quadriceps muscle thickness predicted increased morbidity/mortality in ICU patients and has been suggested to be an objective biomarker to determine fitness for aggressive treatment. US measures of muscle loss in the critically ill will aid in the development of appropriate intervention strategies. Alternatively, qualitative muscle evaluation through the measure of echogenicity (using image gray-scale visual analysis) is a sensitive indicator of muscle atrophy. The ultrasound can contribute to assessing necrosis, fatty infiltration, and inflammation in place of invasive muscle biopsy in critically ill patients. Ultrasound offers an important tool for early non-volitional assessment of muscle function in the critically ill.
US characterization of muscle changes would facilitate the development and monitoring of muscle-targeted nutrition and physical therapy interventions. Knowing body muscle and adipose tissue mass is essential in several clinical situations to adapt drug dose to the volume of distribution and to guide nutrition as well as physical therapy. US imaging is a practical method for the prospective assessment of SM (skeletal muscle) changes in response to illness and treatment. Previous ICU studies have focused on measurements of muscle quantity (muscle thickness and CSA) in both the quadriceps, a muscle region known to be rapidly impacted by sarcopenia, and to correlate with ICU survival. Ultrasound has been used primarily as a tool for body composition measurement in clinical nutrition. Although many recent reports have demonstrated that ultrasound could be a useful tool for nutritional assessment and body composition assessment, it is not well incorporated into ICU practice regarding nutritional assessment and follow-up This trial is the first to investigate the role of ultrasound in detecting body composition in critically ill obstetrics and gynecological cases and its correlation with clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| critically ill obstetrics patients , admitted to ICU | – | Diagnostic Test: ultrasound detection of body composition |
| critically ill gynecological cases, admitted to ICU | – | Diagnostic Test: ultrasound detection of body composition |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Critically ill women whether pregnant, peripartum, postoperative, or admitted for any critical illness.
Key inclusion criteria (3 listed)
- females with age 16 with no upper limit
- American Society of Anesthesiologists (ASA) class I, II or III,
- admitted to the obstetrics and Gynecology critical care unit
Key exclusion criteria (1 listed)
- Patient refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound detection of body compositionMuscle mass and fat thickness assessed at two representative sites (rectus femoris, biceps brachii) per USVALID (Arabella, 2020). Muscle quality graded via validated 4-point Heckmatt echogenicity scale (Grade 1=normal, Grade 4=severe; full criteria in Outcome Measures).Subcutaneous fat thickness(mm) measured on rectus femoris. FLUID protocol for oedema: 36-site USEG 5-point scale . Day 0, day 2, then every 2 days untill at in-stay deterioration or death or discharge. | Diagnostic test | critically ill gynecological cases, admitted to ICU, critically ill obstetrics patients , admitted to ICU |
Primary outcome
change in body composition-muscular element
Time frame: on the day of admission , repeated every 2 days till death or discharge which come first, assessed up to 20 days from admission
Change in muscle thickness (mm) and change in muscle quality, assessed by ultrasound echogenicity at two representative sites: rectus femoris (lower limb) and biceps brachii (upper limb). Muscle quality is graded using the validated four-point Heckmatt scale: Grade 1 = normal echogenicity with distinct bone reflection; Grade 2 = increased echogenicity with preserved architecture and normal bone reflection; Grade 3 = further increased echogenicity with some loss of architecture and reduced bone reflection; Grade 4 = markedly increased echogenicity with total loss of architecture and absent bone reflection. A derived ordinal muscle severity category is calculated from the highest grade observed across the two sites.
change in body composition-fat element
Time frame: on the day of admission , repeated every 2 days till death or discharge which come first, assessed up to 20 days from admission.
change in thickness of subcutaneous fat measured in mm. A derived categorical adiposity classification (low, normal, or high adipose reserve) is also calculated from this measurement.
change in body composition-extreacellular oedema element
Time frame: on the day of admission , repeated every 2 days till death or discharge which come first .
The examiner will use a 5-point scale of ultrasonic subcutaneous edema grade (USEG) to evaluate subcutaneous edema at each site based on echo intensity, tissue transparency, and fluid properties. The final ultrasonic subcutaneous edema score (USES) is calculated by adding scores from 36 subcutaneous sites (0-144), regionally grouped: hands (0-8), arms (0-16), thoracic wall (0-32), abdominal wall (0-32), thigh (0-24), calves (0-24), feet (0-8), with regional totals averaged to a 0-4 score per region. Lower scores indicate lower oedema severity. A derived categorical oedema severity classification is also calculated from the total score.
1 secondary outcome
co-relation of the change of any elements of body composition with poor outcomes suchs such as death, need for ventilatory or circulatory support or increase the length of stay in icu.
Time frame: from occurence of change in body composition till the poor outcome. till discharge from icu or death which come first, assessed till 20 days from admission
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 4 Sep 2026.
- Background: PubMed 36997242Gursoy C, Alkan A, Kaya Cubuk E, Karci E, Yilmaz HO, Cakir T. Rectus abdominis and rectus femoris muscle thickness in determining nutritional risk in critically ill patients: a prospective cohort study in Turkey. BMJ Open. 2023 Mar 30;13(3):e071796. doi: 10.1136/bmjopen-2023-071796.
- Background: PubMed 32742962Ponti F, De Cinque A, Fazio N, Napoli A, Guglielmi G, Bazzocchi A. Ultrasound imaging, a stethoscope for body composition assessment. Quant Imaging Med Surg. 2020 Aug;10(8):1699-1722. doi: 10.21037/qims-19-1048.
- Background: PubMed 36934293Zhang W, Gu Y, Zhao Y, Lian J, Zeng Q, Wang X, Wu J, Gu Q; Chinese Critical Care Ultrasound Study Group (CCUSG). Focused liquid ultrasonography in dropsy protocol for quantitative assessment of subcutaneous edema. Crit Care. 2023 Mar 18;27(1):114. doi: 10.1186/s13054-023-04403-y.
- Individual participant dataSharing planned: Yes
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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.
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 Muscle Loss and Extracellular Fluid Alteration, run by Ain Shams University at 1 site in Egypt.
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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 4 Sep 2026. 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 Egypt. 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?
Contact wessam selima, MD (01001958858, w.z.selima@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in body composition-muscular element (time frame: on the day of admission , repeated every 2 days till death or discharge which come first, assessed up to 20 days from admission). The study lists 3 primary outcomes in all. 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 NCT06728722, which also lists 3 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 4 Sep 2026.