Nutritional StatusNCT07475767
Ultrasound, Nutritional Status, and Outcomes in Surgical ICU
An observational study of Nutritional Status and Muscle Thickness of the Quadriceps Femoris, run by Osijek University Hospital at 1 site in Croatia.
Trial summary
Ultrasound Indicators of Nutritional Status and Treatment Outcomes in Surgical Patients in the Intensive Care Unit Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nutritional Status, Muscle Thickness of the Quadriceps Femoris, Frailty
- How many people
- 50 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Feb 2026to Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be randomly selected patients admitted to the intensive care unit after undergoing a surgical procedure. These surgical procedures include abdominal, neurosurgical, plastic-reconstructive, traumatological, thoracic, and maxillofacial surgeries. Patients will be included regardless of age, gender, or whether the procedure was emergency or elective.
Who may be able to join
- postoperative intensive care
Who cannot join
- surgery of the right leg
- paraplegia, tetraplegia
- refusal of the patient/guardian to participate in the research (informed consent not signed)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Croatia1 site, 1 recruiting
- Recruiting
Osijek University Hospital; Medical Faculty
Osijek, 31000
Slavica Kvolik, 098723925, skvolik@mefos.hr
About this study
Official title: Ultrasound Indicators of Nutritional Status and Treatment Outcomes in Surgical Patients in the Intensive Care Unit
Ultrasound Indicators of Nutritional Status and Treatment Outcomes in Surgical Patients in the Intensive Care Unit
Read the detailed description
The surgical intensive care unit (ICU) provides continuous preoperative and postoperative monitoring of hemodynamically unstable, critically or potentially critically ill patients whose treatment requirements exceed the scope of the competent surgical department. The most common reasons for admission to the ICU are older age, multiple comorbidities, sepsis, demanding and high-risk surgery, and complications during the procedure. The literature increasingly reports that patients' nutritional status and clinical frailty are predictors of ICU treatment duration and outcome. The nutritional status (NS) of patients in intensive care units (ICUs) is assessed using clinical and laboratory indicators, including body mass index (BMI), the clinical frailty score, and hemoglobin and albumin levels. It is quantified by rating scales such as NRS (Nutritional Risk Screening) and MUST (Malnutrition Universal Screening Tool).
Frailty syndrome is defined as a patient's reduced capacity to tolerate changes in physical, physiological, and cognitive body functions. Given the reduction in the organism's physiological reserves, the patient becomes vulnerable to stressors and acute complications associated with the health condition. Patient frailty is correlated with aging, and age is among the most important determinants of frailty. In the intensive care unit, patient frailty is an important predictor of the duration and outcome of treatment, the development of complications during hospitalization, and, as noted above, the consumption of available resources. Assessment of patient frailty enables the appropriate selection of therapeutic procedures and provides overall support to the patient, aiming to achieve optimal treatment outcomes. Patient frailty can be measured using clinical scales; the most commonly used are the Clinical Frailty Scale (CSF) and the modified frailty index (mFI).
Ultrasound is a diagnostic tool that, due to its non-invasiveness and ease of use, is increasingly used to assess the patient's condition and changes during treatment. The most commonly measured ultrasound indicators in intensive care are the presence of effusion or blood in body cavities, flow through blood vessels, and measurement of distance for puncture purposes.
Ultrasound has recently been used to assess the patient's nutritional status by measuring muscle thickness and echogenicity, most often of the upper leg muscles, such as the quadriceps. Muscle cross-sectional area and the thickness of the adipose tissue above it are often measured.
Studies on nutritional status and its relationship with muscle echogenicity in the surgical patient population are rare.
The prospective observational study will include consecutive patients of both genders admitted to the Department of Intensive Care of the Clinical Hospital Center in Osijek. The expected number of subjects is 50. The study will be conducted after approval by the ethics committee of the Clinical Hospital Center in Osijek, and before inclusion, the investigator will obtain informed consent from the patient or a guardian. Patients who have had surgery on their right leg, on which muscle thickness and echogenicity will be measured, patients for whom informed consent is not obtained, and patients who are paraplegic will not be included in the study.
Demographic data will be recorded from medical records and the hospital information system for each individual subject. Patient demographics (age, gender), comorbidities, laboratory parameters (hemoglobin, albumin, lactate), reason and duration of intensive care unit hospitalization, and time required to wean the patient from mechanical ventilation will be recorded. Patient frailty will be assessed during an interview. For patients who are unable to provide information, information will be collected from family members. For the purposes of this study, the CFS will be used, which categorizes patients from 1 (very active, physically strong) to 9 (very sick, not expected to survive more than 6 months). The examiner will perform an ultrasound examination of the thigh muscles (m. rectus femoris, m. vastus intermedius, m. vastus medialis, m. vastus lateralis) with a linear ultrasound probe for each subject within 48 hours of admission to the intensive care unit (ICU), measure the thickness of the muscle and the fatty tissue immediately above it, and display the dimensions in mm. Muscle echogenicity will be expressed numerically using image analysis. Signal intensity will be calculated in a standard 5 × 5 mm area, equal across all images, using the ImageJ/Fiji software. The average of 3 ultrasound measurements will be calculated. In addition to ultrasound measurements, laboratory indicators of the patient's nutritional status are also important. Hemoglobin and serum albumin are most often associated with nutritional status. Their values are usually reduced in patients with clinical frailty, and the finding of anemia and hypoproteinemia of varying degrees is common in people with limited mobility, malnutrition, or in people with specific nutritional deficiencies, e.g., in liver cirrhosis. The values will be compared computationally with clinical indicators such as patient frailty, hemoglobin, albumin and the patient's status assessment obtained by rating scales (CSF, NRS).
- Keywords
- Nutritional Status, Risk Assessment, Ultrasonography, Intensive Care Units, Postoperative Care
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Surgical patients in the intensive care unit | The prospective observational study will include consecutive patients admitted to the Department of Intensive Care of the Clinical Hospital Center in Osijek. Patients will be randomly included, regardless of age, gender, or type of surgical procedure. The study will be conducted after approval by the ethics committee of the Clinical Hospital Center in Osijek, and before inclusion, the investigator will obtain informed consent from the patient or a guardian. Patients who have had surgery on their right leg, on which muscle thickness and echogenicity will be measured, patients for whom informed consent is not obtained, and patients who are paraplegic will not be included in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Frailty Scale
The Clinical Frailty Scale (CFS) is a 9-point clinician-judgment tool that assesses fitness-to-frailty (1=Very Fit, 9=Terminally Ill).
Measured: Day 1 (within 24 hours from admission to the intensive care unit)
Nutritional Risk Screening 2002
The Nutritional Risk Screening 2002 (NRS-2002) is a rapid, validated tool designed by the European Society for Clinical Nutrition and Metabolism (ESPEN) to identify hospitalized patients at risk of malnutrition and requiring nutritional support. It calculates a total score (0-7) based on impaired nutritional status, disease severity, and age (≥70 years).
Measured: Day 1
Vastus intermedius thickness
Vastus intermedius thickness measured by ultrasound and expressed in centimeters.
Measured: Day 1
Rectus femoris thickness
Rectus femoris thickness measured by ultrasound and expressed in centimeters.
Measured: Day 1
Vastus medialis thickness
Vastus medialis thickness measured by ultrasound and expressed in centimeters.
Measured: Day 1
Vastus lateralis thickness
Vastus lateralis thickness measured by ultrasound and expressed in centimeters.
Measured: Day 1
Vastus intermedius echogenicity
Muscle echogenicity will be analyzed using ImageJ software and expressed as the mean gray value.
Measured: Day 1
Rectus femoris echogenicity
Muscle echogenicity will be analyzed using ImageJ software and expressed as mean grey value.
Measured: Day 1
Vastus medialis echogenicity
Muscle echogenicity will be analyzed using ImageJ software and expressed as mean grey value.
Measured: Day 1
Vastus lateralis echogenicity
Muscle echogenicity will be analyzed using ImageJ software and expressed as the mean gray value.
Measured: Day 1
Adipose tissue thickness
Thickness of adipose tissue above quadriceps femoris muscle will be mesured by ultrasound and expressed in centimeters.
Measured: Day 1
Body mass index ˙(BMI)
Body Mass Index (BMI) is a screening tool that estimates body fat by dividing a person's weight in kilograms by the square of their height in meters (kg/m2)
Measured: Perioperative
Length of mechanical ventilation
Time from admission to the intensive care unit to the onset of spontaneous breathing. The time of admission to the intensive care unit is the start of mechanical ventilation. It lasts until extubation (removal of the endotracheal tube) and continuation of spontaneous breathing. It is expressed in hours.
Whether the patient is intubated again, these two ventilation times are added together.
Measured: One month from admission to the ICU.
Secondary outcomes (4)
Haemoglobin
Haemoglobin levels (g/L) will be measured in the blood sample.
Measured: Day 1
Albumin
The albumin level (g/L) will be measured in the blood sample.
Measured: Day 1
C-reactive protein (CRP)
C-reactive protein (CRP) is a liver-produced protein that serves as a key biomarker of systemic inflammation, infection, and tissue damage. CRP (mg/L) will be measured in the blood sample.
Measured: Perioperative
Lactate
Lactate (mmol/L) is an energy source and a metabolic product produced in muscles, red blood cells, and the brain during anaerobic metabolism. It serves as a marker of tissue oxygenation, with elevated blood levels suggesting potential metabolic stress.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 Feb 2026
- Primary completionJun 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Nutritional StatusStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Osijek University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Slavica Kvolik, prof., Study chair, Osijek University Hospital; Medical Faculty Osijek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07475767
- Sponsor's protocol ID
- R1-13343
- Status last verified
- May 2026
- First submitted
- 9 Mar 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes, upon request sent to principal investigator
Publications
Casey P, Alasmar M, McLaughlin J, Ang Y, McPhee J, Heire P, Sultan J. The current use of ultrasound to measure skeletal muscle and its ability to predict clinical outcomes: a systematic review. J Cachexia Sarcopenia Muscle. 2022 Oct;13(5):2298-2309. doi: 10.1002/jcsm.13041. Epub 2022 Jul 19.
PubMed 35851996Xin C, Ma M, Wang Q, Li T, Sun Q, Jiang M, Du J, Li Z, Ma J. Correlation of ultrasound measurement of limb muscle thickness and echo intensity with frailty assessment in elderly patients undergoing malignancies surgery. Heliyon. 2024 Jan 3;10(1):e24017. doi: 10.1016/j.heliyon.2024.e24017. eCollection 2024 Jan 15.
PubMed 38230231De Biasio JC, Mittel AM, Mueller AL, Ferrante LE, Kim DH, Shaefi S. Frailty in Critical Care Medicine: A Review. Anesth Analg. 2020 Jun;130(6):1462-1473. doi: 10.1213/ANE.0000000000004665.
PubMed 32384336Kalaiselvan MS, Yadav A, Kaur R, Menon A, Wasnik S. Prevalence of Frailty in ICU and its Impact on Patients' Outcomes. Indian J Crit Care Med. 2023 May;27(5):335-341. doi: 10.5005/jp-journals-10071-24456.
PubMed 37214110Bakshi N, Khurana A, Ferozi S. Nutrition Screening and Assessment among Critically Ill Patients [Internet]. Nutrition During Intensive Care. IntechOpen; 2024. https://doi.org/10.5772/intechopen.1007337
Rohrig SAH, Lance MD, Faisal Malmstrom M. Surgical intensive care - current and future challenges? Qatar Med J. 2020 Jan 13;2019(2):3. doi: 10.5339/qmj.2019.qccc.3. eCollection 2019.
PubMed 31976309Girgin T, Sayur V, Guler E, Uc C, Goktepe B, Ersin S, Uyar M, Sezer TO. Predictors of Mortality in Surgical Patients Admitted to a Tertiary Intensive Care Unit. J Clin Med. 2025 Sep 9;14(18):6369. doi: 10.3390/jcm14186369.
PubMed 41010574
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Indicators of Nutritional Status and Treatment Outcomes in Surgical Patients in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT07475767
- Acronym / sponsor ID
- R1-13343
- Keywords
- Nutritional Status, Risk Assessment, Ultrasonography, Intensive Care Units, Postoperative Care
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Osijek University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 16 Mar 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.
Ultrasound Indicators of Nutritional Status and Treatment Outcomes in Surgical Patients in the Intensive Care Unit
Detailed description
The surgical intensive care unit (ICU) provides continuous preoperative and postoperative monitoring of hemodynamically unstable, critically or potentially critically ill patients whose treatment requirements exceed the scope of the competent surgical department. The most common reasons for admission to the ICU are older age, multiple comorbidities, sepsis, demanding and high-risk surgery, and complications during the procedure. The literature increasingly reports that patients' nutritional status and clinical frailty are predictors of ICU treatment duration and outcome. The nutritional status (NS) of patients in intensive care units (ICUs) is assessed using clinical and laboratory indicators, including body mass index (BMI), the clinical frailty score, and hemoglobin and albumin levels. It is quantified by rating scales such as NRS (Nutritional Risk Screening) and MUST (Malnutrition Universal Screening Tool).
Frailty syndrome is defined as a patient's reduced capacity to tolerate changes in physical, physiological, and cognitive body functions. Given the reduction in the organism's physiological reserves, the patient becomes vulnerable to stressors and acute complications associated with the health condition. Patient frailty is correlated with aging, and age is among the most important determinants of frailty. In the intensive care unit, patient frailty is an important predictor of the duration and outcome of treatment, the development of complications during hospitalization, and, as noted above, the consumption of available resources. Assessment of patient frailty enables the appropriate selection of therapeutic procedures and provides overall support to the patient, aiming to achieve optimal treatment outcomes. Patient frailty can be measured using clinical scales; the most commonly used are the Clinical Frailty Scale (CSF) and the modified frailty index (mFI).
Ultrasound is a diagnostic tool that, due to its non-invasiveness and ease of use, is increasingly used to assess the patient's condition and changes during treatment. The most commonly measured ultrasound indicators in intensive care are the presence of effusion or blood in body cavities, flow through blood vessels, and measurement of distance for puncture purposes.
Ultrasound has recently been used to assess the patient's nutritional status by measuring muscle thickness and echogenicity, most often of the upper leg muscles, such as the quadriceps. Muscle cross-sectional area and the thickness of the adipose tissue above it are often measured.
Studies on nutritional status and its relationship with muscle echogenicity in the surgical patient population are rare.
The prospective observational study will include consecutive patients of both genders admitted to the Department of Intensive Care of the Clinical Hospital Center in Osijek. The expected number of subjects is 50. The study will be conducted after approval by the ethics committee of the Clinical Hospital Center in Osijek, and before inclusion, the investigator will obtain informed consent from the patient or a guardian. Patients who have had surgery on their right leg, on which muscle thickness and echogenicity will be measured, patients for whom informed consent is not obtained, and patients who are paraplegic will not be included in the study.
Demographic data will be recorded from medical records and the hospital information system for each individual subject. Patient demographics (age, gender), comorbidities, laboratory parameters (hemoglobin, albumin, lactate), reason and duration of intensive care unit hospitalization, and time required to wean the patient from mechanical ventilation will be recorded. Patient frailty will be assessed during an interview. For patients who are unable to provide information, information will be collected from family members. For the purposes of this study, the CFS will be used, which categorizes patients from 1 (very active, physically strong) to 9 (very sick, not expected to survive more than 6 months). The examiner will perform an ultrasound examination of the thigh muscles (m. rectus femoris, m. vastus intermedius, m. vastus medialis, m. vastus lateralis) with a linear ultrasound probe for each subject within 48 hours of admission to the intensive care unit (ICU), measure the thickness of the muscle and the fatty tissue immediately above it, and display the dimensions in mm. Muscle echogenicity will be expressed numerically using image analysis. Signal intensity will be calculated in a standard 5 × 5 mm area, equal across all images, using the ImageJ/Fiji software. The average of 3 ultrasound measurements will be calculated. In addition to ultrasound measurements, laboratory indicators of the patient's nutritional status are also important. Hemoglobin and serum albumin are most often associated with nutritional status. Their values are usually reduced in patients with clinical frailty, and the finding of anemia and hypoproteinemia of varying degrees is common in people with limited mobility, malnutrition, or in people with specific nutritional deficiencies, e.g., in liver cirrhosis. The values will be compared computationally with clinical indicators such as patient frailty, hemoglobin, albumin and the patient's status assessment obtained by rating scales (CSF, NRS).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical patients in the intensive care unit | – | –The prospective observational study will include consecutive patients admitted to the Department of Intensive Care of the Clinical Hospital Center in Osijek. Patients will be randomly included, regardless of age, gender, or type of surgical procedure. The study will be conducted after approval by the ethics committee of the Clinical Hospital Center in Osijek, and before inclusion, the investigator will obtain informed consent from the patient or a guardian. Patients who have had surgery on their right leg, on which muscle thickness and echogenicity will be measured, patients for whom informed consent is not obtained, and patients who are paraplegic will not be included in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be randomly selected patients admitted to the intensive care unit after undergoing a surgical procedure. These surgical procedures include abdominal, neurosurgical, plastic-reconstructive, traumatological, thoracic, and maxillofacial surgeries. Patients will be included regardless of age, gender, or whether the procedure was emergency or elective.
Key inclusion criteria (1 listed)
- postoperative intensive care
Key exclusion criteria (3 listed)
- surgery of the right leg
- paraplegia, tetraplegia
- refusal of the patient/guardian to participate in the research (informed consent not signed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical Frailty Scale
Time frame: Day 1 (within 24 hours from admission to the intensive care unit)
The Clinical Frailty Scale (CFS) is a 9-point clinician-judgment tool that assesses fitness-to-frailty (1=Very Fit, 9=Terminally Ill).
Nutritional Risk Screening 2002
Time frame: Day 1
The Nutritional Risk Screening 2002 (NRS-2002) is a rapid, validated tool designed by the European Society for Clinical Nutrition and Metabolism (ESPEN) to identify hospitalized patients at risk of malnutrition and requiring nutritional support. It calculates a total score (0-7) based on impaired nutritional status, disease severity, and age (≥70 years).
Vastus intermedius thickness
Time frame: Day 1
Vastus intermedius thickness measured by ultrasound and expressed in centimeters.
Rectus femoris thickness
Time frame: Day 1
Rectus femoris thickness measured by ultrasound and expressed in centimeters.
Vastus medialis thickness
Time frame: Day 1
Vastus medialis thickness measured by ultrasound and expressed in centimeters.
Vastus lateralis thickness
Time frame: Day 1
Vastus lateralis thickness measured by ultrasound and expressed in centimeters.
Vastus intermedius echogenicity
Time frame: Day 1
Muscle echogenicity will be analyzed using ImageJ software and expressed as the mean gray value.
Rectus femoris echogenicity
Time frame: Day 1
Muscle echogenicity will be analyzed using ImageJ software and expressed as mean grey value.
Vastus medialis echogenicity
Time frame: Day 1
Muscle echogenicity will be analyzed using ImageJ software and expressed as mean grey value.
Vastus lateralis echogenicity
Time frame: Day 1
Muscle echogenicity will be analyzed using ImageJ software and expressed as the mean gray value.
Adipose tissue thickness
Time frame: Day 1
Thickness of adipose tissue above quadriceps femoris muscle will be mesured by ultrasound and expressed in centimeters.
Body mass index ˙(BMI)
Time frame: Perioperative
Body Mass Index (BMI) is a screening tool that estimates body fat by dividing a person's weight in kilograms by the square of their height in meters (kg/m2)
Length of mechanical ventilation
Time frame: One month from admission to the ICU.
Time from admission to the intensive care unit to the onset of spontaneous breathing. The time of admission to the intensive care unit is the start of mechanical ventilation. It lasts until extubation (removal of the endotracheal tube) and continuation of spontaneous breathing. It is expressed in hours. Whether the patient is intubated again, these two ventilation times are added together.
4 secondary outcomes
Haemoglobin
Time frame: Day 1
Albumin
Time frame: Day 1
C-reactive protein (CRP)
Time frame: Perioperative
Lactate
Time frame: Day 1
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 29 May 2026.
- Background: PubMed 35851996Casey P, Alasmar M, McLaughlin J, Ang Y, McPhee J, Heire P, Sultan J. The current use of ultrasound to measure skeletal muscle and its ability to predict clinical outcomes: a systematic review. J Cachexia Sarcopenia Muscle. 2022 Oct;13(5):2298-2309. doi: 10.1002/jcsm.13041. Epub 2022 Jul 19.
- Background: PubMed 38230231Xin C, Ma M, Wang Q, Li T, Sun Q, Jiang M, Du J, Li Z, Ma J. Correlation of ultrasound measurement of limb muscle thickness and echo intensity with frailty assessment in elderly patients undergoing malignancies surgery. Heliyon. 2024 Jan 3;10(1):e24017. doi: 10.1016/j.heliyon.2024.e24017. eCollection 2024 Jan 15.
- Background: PubMed 32384336De Biasio JC, Mittel AM, Mueller AL, Ferrante LE, Kim DH, Shaefi S. Frailty in Critical Care Medicine: A Review. Anesth Analg. 2020 Jun;130(6):1462-1473. doi: 10.1213/ANE.0000000000004665.
- Background: PubMed 37214110Kalaiselvan MS, Yadav A, Kaur R, Menon A, Wasnik S. Prevalence of Frailty in ICU and its Impact on Patients' Outcomes. Indian J Crit Care Med. 2023 May;27(5):335-341. doi: 10.5005/jp-journals-10071-24456.
- BackgroundBakshi N, Khurana A, Ferozi S. Nutrition Screening and Assessment among Critically Ill Patients [Internet]. Nutrition During Intensive Care. IntechOpen; 2024. https://doi.org/10.5772/intechopen.1007337
- Background: PubMed 31976309Rohrig SAH, Lance MD, Faisal Malmstrom M. Surgical intensive care - current and future challenges? Qatar Med J. 2020 Jan 13;2019(2):3. doi: 10.5339/qmj.2019.qccc.3. eCollection 2019.
- Background: PubMed 41010574Girgin T, Sayur V, Guler E, Uc C, Goktepe B, Ersin S, Uyar M, Sezer TO. Predictors of Mortality in Surgical Patients Admitted to a Tertiary Intensive Care Unit. J Clin Med. 2025 Sep 9;14(18):6369. doi: 10.3390/jcm14186369.
- Individual participant dataSharing planned: Yes. Yes, upon request sent to principal investigator
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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.
Slavica Kvolik, prof. study chair
Osijek University Hospital; Medical Faculty Osijek
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 Nutritional Status and Muscle Thickness of the Quadriceps Femoris, run by Osijek University Hospital at 1 site in Croatia.
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 1 inclusion and 3 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 29 May 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 Croatia. 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 Slavica Kvolik, prof. (098723925, skvolik@mefos.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Frailty Scale (time frame: Day 1 (within 24 hours from admission to the intensive care unit)). The study lists 13 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 NCT07475767, which also lists 7 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 29 May 2026.