Intracerebral HemorrhageNCT07712198
Al Prediction of Sarcopenia Risk in Neurocritical ICU Patients
An observational study of Intracerebral Hemorrhage and Subarachnoid Hemorrhage, run by Trabzon Kanuni Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study aims to evaluate sarcopenia in intensive care patients with intracranial pathologies using ultrasound and to compare the predictive performance of different artificial intelligence models. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intracerebral Hemorrhage, Subarachnoid Hemorrhage, Subdural Hematoma
- What is being tested?
- Prospective Observational Assessment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2026to 30 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult intensive care unit patients aged 18-65 years admitted with intracranial pathologies, including intracerebral hemorrhage, epidural hemorrhage, subdural hemorrhage, subarachnoid hemorrhage, intracranial tumors, and ischemic stroke.
Who may be able to join
- Age between 18 and 65 years
- Admission to the intensive care unit due to intracranial pathology (intracerebral hemorrhage, epidural hemorrhage, subdural hemorrhage, subarachnoid hemorrhage, intracranial tumors, or ischemic stroke)
- Informed consent obtained from the patient or legally authorized representative
Who cannot join
- Age <18 years or >65 years
- Failure to achieve nutritional targets according to ESPEN guidelines
- Palliative care or home care patients
- Morbid obesity (BMI ≥40 kg/m²)
- History of neuromuscular disease
- Lower extremity amputation
- History of trauma affecting the thigh region
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Trabzon University Faculty of Medicine, Kanuni Training and Research Hospital, Trabzon, 61080
Trabzon, Trabzon
About this study
Official title: Artificial Intelligence-Based Prediction of Sarcopenia Risk in Intensive Care Unit Patients With Intracranial Pathology
This prospective observational study aims to evaluate sarcopenia in intensive care patients with intracranial pathologies using ultrasound and to compare the predictive performance of different artificial intelligence models. Rectus femoris muscle thickness will be measured by ultrasound on ICU admission (Day 0) and Day 7. Prealbumin levels will be assessed on Days 0, 3, and 7, and the modified Nutrition Risk in Critically Ill (mNUTRIC) score will be calculated on the first day of ICU admission. Clinical, laboratory, and ultrasonographic data will be integrated into different artificial intelligence models to predict sarcopenia status on Day 7. The study aims to determine the effectiveness of artificial intelligence in the early identification of sarcopenia and to support future clinical decision-making in intensive care practice.
Read the detailed description
This study is designed as a prospective observational study. Patients admitted to the Level III Intensive Care Units of Trabzon University Faculty of Medicine, Kanuni Training and Research Hospital, Kaşüstü Campus, due to intracranial pathologies between January 1, 2026, and June 30, 2026, will be included. Approximately 100-150 patients are planned to be evaluated.
Demographic data of the enrolled patients will be recorded, and the modified Nutrition Risk in Critically Ill (mNUTRIC) score will be calculated on the first day of intensive care unit admission. Rectus femoris muscle thickness will be evaluated by ultrasonography on Day 0 and Day 7 of ICU admission. All ultrasonographic measurements will be performed using the same ultrasound device and by the same investigator according to a standardized protocol. During the measurements, the patient will be positioned supine, the knee will be kept in extension, and the muscle will be evaluated in a relaxed position. Three repeated measurements will be obtained at each assessment, and the mean value will be recorded.
As part of the laboratory assessment, prealbumin levels will be measured on Days 0, 3, and 7. Biochemical parameters evaluated during routine clinical follow-up will be recorded from the hospital information system.
No intervention, additional procedure, or treatment modification will be performed as part of this study. All data will consist of observational data obtained during routine clinical follow-up. Data collection will be conducted by a resident physician from the Department of Anesthesiology and Reanimation with experience in intensive care.
The collected clinical, laboratory, and ultrasonographic data will be provided to different artificial intelligence models, and their accuracy and performance in predicting sarcopenia development on Day 7 will be evaluated. The primary objective of the study is to assess the predictive performance of artificial intelligence models, including ChatGPT, Gemini, and Claude, for Day 7 sarcopenia development in intensive care patients with intracranial pathologies. Secondary objectives include comparing artificial intelligence predictions with clinical assessments, comparing predictive performance among different artificial intelligence models, and evaluating the potential usability of artificial intelligence models as clinical decision-support tools in intensive care practice.
All data will be de-identified before analysis, and patient confidentiality will be maintained. Study data will be stored in a secure digital environment accessible only to the research team.
- Conditions
- Intracerebral Hemorrhage, Subarachnoid Hemorrhage, Subdural Hematoma, Epidural Hematoma, Ischemic Stroke, Brain Neoplasms
- Being tested
- Prospective Observational Assessment
- Keywords
- Sarcopenia, Artificial Intelligence, Intensive Care Unit, Rectus Femoris, Ultrasonography, mNUTRIC, Prealbumin, Intracranial Pathology
- Medical subject headings
- Cerebral Hemorrhage, Subarachnoid Hemorrhage, Hematoma, Subdural, Hematoma, Epidural, Spinal, Ischemic Stroke, Brain Neoplasms, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prospective Observational AssessmentOther
Prospective observational assessment including rectus femoris ultrasonography, prealbumin measurements, mNUTRIC scoring, and collection of routine clinical data. No experimental intervention or treatment modification will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Intracranial Pathology ICU Patients | Adult patients admitted to the intensive care unit with intracranial pathologies, including intracerebral hemorrhage, subarachnoid hemorrhage, subdural hematoma, epidural hematoma, intracranial tumors, and ischemic stroke. Participants will be prospectively observed. Rectus femoris muscle thickness will be measured by ultrasonography on days 0 and 7, and prealbumin levels will be assessed on days 0, 3, and 7. No experimental intervention or treatment modification will be performed. Receives: Other: Prospective Observational Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Artificial Intelligence Models in Predicting Day-7 Sarcopenia
Evaluation of the predictive performance of ChatGPT, Gemini, and Claude models for day-7 sarcopenia in ICU patients with intracranial pathology using rectus femoris muscle thickness, prealbumin levels, and clinical data.
Measured: 7 Days
Secondary outcomes (2)
Comparison of Predictive Performance Among AI Models
Comparison of prediction accuracy among ChatGPT, Gemini, and Claude models for day-7 sarcopenia.
Measured: 7 Days
Agreement Between AI Predictions and Clinical Assessment
Evaluation of concordance between artificial intelligence model predictions and clinically determined sarcopenia status.
Measured: 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start1 Jan 2026
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
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 Intracerebral HemorrhageStudies of the same condition, open and under way.
- 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trabzon Kanuni Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07712198
- Sponsor's protocol ID
- 10496660-2026-25030
- Status last verified
- Aug 2026
- First submitted
- 14 Jul 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. The collected data will be used only for the purposes of this study and will remain confidential in accordance with institutional and ethical regulations.
Publications
Phongpreecha T, Ghanem M, Reiss JD, Oskotsky TT, Mataraso SJ, De Francesco D, Reincke SM, Espinosa C, Chung P, Ng T, Costello JM, Sequoia JA, Razdan S, Xie F, Berson E, Kim Y, Seong D, Szeto MY, Myers F, Gu H, Feister J, Verscaj CP, Rose LA, Sin LWY, Oskotsky B, Roger J, Shu CH, Shome S, Yang LK, Tan Y, Levitte S, Wong RJ, Gaudilliere B, Angst MS, Montine TJ, Kerner JA, Keller RL, Shaw GM, Sylvester KG, Fuerch J, Chock V, Gaskari S, Stevenson DK, Sirota M, Prince LS, Aghaeepour N. AI-guided precision parenteral nutrition for neonatal intensive care units. Nat Med. 2025 Jun;31(6):1882-1894. doi: 10.1038/s41591-025-03601-1. Epub 2025 Mar 25.
PubMed 40133525Lopez-Gomez JJ, Sanchez-Lite I, Fernandez-Velasco P, Izaola-Jauregui O, Cebria A, Perez-Lopez P, Gonzalez-Gutierrez J, Estevez-Asensio L, Primo-Martin D, Gomez-Hoyos E, Jorge-Godoy E, De Luis-Roman DA. Artificial intelligence-assisted rectus femoris ultrasound vs. L3 computed tomography for sarcopenia assessment in oncology patients: establishing diagnostic cut-offs for muscle mass and quality. Front Nutr. 2025 Sep 25;12:1678989. doi: 10.3389/fnut.2025.1678989. eCollection 2025.
PubMed 41080186Choi YH, Kim DH, Jeon ET, Lee HJ, Park TY, Yoon SH, Jin KN, Lee HW. Cluster analysis of thoracic muscle mass using artificial intelligence in severe pneumonia. Sci Rep. 2024 Jul 23;14(1):16912. doi: 10.1038/s41598-024-67625-2.
PubMed 39043882
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence-Based Prediction of Sarcopenia Risk in Intensive Care Unit Patients With Intracranial Pathology
- ClinicalTrials.gov ID
- NCT07712198
- Acronym / sponsor ID
- 10496660-2026-25030
- Conditions
- Intracerebral Hemorrhage, Subarachnoid Hemorrhage, Subdural Hematoma, Epidural Hematoma, Ischemic Stroke, Brain Neoplasms
- Keywords
- Sarcopenia, Artificial Intelligence, Intensive Care Unit, Rectus Femoris, Ultrasonography, mNUTRIC, Prealbumin, Intracranial Pathology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Trabzon Kanuni Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 17 Jul 2026 (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.
This prospective observational study aims to evaluate sarcopenia in intensive care patients with intracranial pathologies using ultrasound and to compare the predictive performance of different artificial intelligence models. Rectus femoris muscle thickness will be measured by ultrasound on ICU admission (Day 0) and Day 7. Prealbumin levels will be assessed on Days 0, 3, and 7, and the modified Nutrition Risk in Critically Ill (mNUTRIC) score will be calculated on the first day of ICU admission. Clinical, laboratory, and ultrasonographic data will be integrated into different artificial intelligence models to predict sarcopenia status on Day 7. The study aims to determine the effectiveness of artificial intelligence in the early identification of sarcopenia and to support future clinical decision-making in intensive care practice.
Detailed description
This study is designed as a prospective observational study. Patients admitted to the Level III Intensive Care Units of Trabzon University Faculty of Medicine, Kanuni Training and Research Hospital, Kaşüstü Campus, due to intracranial pathologies between January 1, 2026, and June 30, 2026, will be included. Approximately 100-150 patients are planned to be evaluated.
Demographic data of the enrolled patients will be recorded, and the modified Nutrition Risk in Critically Ill (mNUTRIC) score will be calculated on the first day of intensive care unit admission. Rectus femoris muscle thickness will be evaluated by ultrasonography on Day 0 and Day 7 of ICU admission. All ultrasonographic measurements will be performed using the same ultrasound device and by the same investigator according to a standardized protocol. During the measurements, the patient will be positioned supine, the knee will be kept in extension, and the muscle will be evaluated in a relaxed position. Three repeated measurements will be obtained at each assessment, and the mean value will be recorded.
As part of the laboratory assessment, prealbumin levels will be measured on Days 0, 3, and 7. Biochemical parameters evaluated during routine clinical follow-up will be recorded from the hospital information system.
No intervention, additional procedure, or treatment modification will be performed as part of this study. All data will consist of observational data obtained during routine clinical follow-up. Data collection will be conducted by a resident physician from the Department of Anesthesiology and Reanimation with experience in intensive care.
The collected clinical, laboratory, and ultrasonographic data will be provided to different artificial intelligence models, and their accuracy and performance in predicting sarcopenia development on Day 7 will be evaluated. The primary objective of the study is to assess the predictive performance of artificial intelligence models, including ChatGPT, Gemini, and Claude, for Day 7 sarcopenia development in intensive care patients with intracranial pathologies. Secondary objectives include comparing artificial intelligence predictions with clinical assessments, comparing predictive performance among different artificial intelligence models, and evaluating the potential usability of artificial intelligence models as clinical decision-support tools in intensive care practice.
All data will be de-identified before analysis, and patient confidentiality will be maintained. Study data will be stored in a secure digital environment accessible only to the research team.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intracranial Pathology ICU Patients | – | Other: Prospective Observational AssessmentAdult patients admitted to the intensive care unit with intracranial pathologies, including intracerebral hemorrhage, subarachnoid hemorrhage, subdural hematoma, epidural hematoma, intracranial tumors, and ischemic stroke. Participants will be prospectively observed. Rectus femoris muscle thickness will be measured by ultrasonography on days 0 and 7, and prealbumin levels will be assessed on days 0, 3, and 7. No experimental intervention or treatment modification will be performed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult intensive care unit patients aged 18-65 years admitted with intracranial pathologies, including intracerebral hemorrhage, epidural hemorrhage, subdural hemorrhage, subarachnoid hemorrhage, intracranial tumors, and ischemic stroke.
Key inclusion criteria (3 listed)
- Age between 18 and 65 years
- Admission to the intensive care unit due to intracranial pathology (intracerebral hemorrhage, epidural hemorrhage, subdural hemorrhage, subarachnoid hemorrhage, intracranial tumors, or ischemic stroke)
- Informed consent obtained from the patient or legally authorized representative
Key exclusion criteria (8 listed)
- Age <18 years or >65 years
- Failure to achieve nutritional targets according to ESPEN guidelines
- Palliative care or home care patients
- Morbid obesity (BMI ≥40 kg/m²)
- History of neuromuscular disease
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 |
|---|---|---|
| Prospective Observational AssessmentProspective observational assessment including rectus femoris ultrasonography, prealbumin measurements, mNUTRIC scoring, and collection of routine clinical data. No experimental intervention or treatment modification will be performed. | Other | Intracranial Pathology ICU Patients |
Primary outcome
Accuracy of Artificial Intelligence Models in Predicting Day-7 Sarcopenia
Time frame: 7 Days
Evaluation of the predictive performance of ChatGPT, Gemini, and Claude models for day-7 sarcopenia in ICU patients with intracranial pathology using rectus femoris muscle thickness, prealbumin levels, and clinical data.
2 secondary outcomes
Comparison of Predictive Performance Among AI Models
Time frame: 7 Days
Agreement Between AI Predictions and Clinical Assessment
Time frame: 7 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Background: PubMed 40133525Phongpreecha T, Ghanem M, Reiss JD, Oskotsky TT, Mataraso SJ, De Francesco D, Reincke SM, Espinosa C, Chung P, Ng T, Costello JM, Sequoia JA, Razdan S, Xie F, Berson E, Kim Y, Seong D, Szeto MY, Myers F, Gu H, Feister J, Verscaj CP, Rose LA, Sin LWY, Oskotsky B, Roger J, Shu CH, Shome S, Yang LK, Tan Y, Levitte S, Wong RJ, Gaudilliere B, Angst MS, Montine TJ, Kerner JA, Keller RL, Shaw GM, Sylvester KG, Fuerch J, Chock V, Gaskari S, Stevenson DK, Sirota M, Prince LS, Aghaeepour N. AI-guided precision parenteral nutrition for neonatal intensive care units. Nat Med. 2025 Jun;31(6):1882-1894. doi: 10.1038/s41591-025-03601-1. Epub 2025 Mar 25.
- Background: PubMed 41080186Lopez-Gomez JJ, Sanchez-Lite I, Fernandez-Velasco P, Izaola-Jauregui O, Cebria A, Perez-Lopez P, Gonzalez-Gutierrez J, Estevez-Asensio L, Primo-Martin D, Gomez-Hoyos E, Jorge-Godoy E, De Luis-Roman DA. Artificial intelligence-assisted rectus femoris ultrasound vs. L3 computed tomography for sarcopenia assessment in oncology patients: establishing diagnostic cut-offs for muscle mass and quality. Front Nutr. 2025 Sep 25;12:1678989. doi: 10.3389/fnut.2025.1678989. eCollection 2025.
- Background: PubMed 39043882Choi YH, Kim DH, Jeon ET, Lee HJ, Park TY, Yoon SH, Jin KN, Lee HW. Cluster analysis of thoracic muscle mass using artificial intelligence in severe pneumonia. Sci Rep. 2024 Jul 23;14(1):16912. doi: 10.1038/s41598-024-67625-2.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. The collected data will be used only for the purposes of this study and will remain confidential in accordance with institutional and ethical regulations.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Intracerebral Hemorrhage and Subarachnoid Hemorrhage, run by Trabzon Kanuni Education and Research Hospital at 1 site in Turkey (Türkiye).
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 8 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: finished, as of the sponsor's last update on 24 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Artificial Intelligence Models in Predicting Day-7 Sarcopenia (time frame: 7 Days). 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 NCT07712198, 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 24 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.