Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 4:16 AM
Study NCT ID:
NCT07475767
Status:
RECRUITING
Last Update Posted:
2026-03-16
First Post:
2026-03-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Indicators of Nutritional Status and Treatment Outcomes in Surgical Patients in the Intensive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-12', 'studyFirstSubmitDate': '2026-03-09', 'studyFirstSubmitQcDate': '2026-03-12', 'lastUpdatePostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Frailty Scale', 'timeFrame': 'Day 1 (within 24 hours from admission to the intensive care unit)', 'description': 'The Clinical Frailty Scale (CFS) is a 9-point, clinician-judgment tool assessing fitness-to-frailty (1=Very Fit, 9=Terminally Ill).'}, {'measure': 'Nutritional Risk Screening 2002', 'timeFrame': 'Day 1', 'description': '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).'}, {'measure': 'Vastus intermedius thickness', 'timeFrame': 'Day 1', 'description': 'Vastus intermedius thickness measured by ultrasound and expressed in centimeters.'}, {'measure': 'Rectus femoris thickness', 'timeFrame': 'Day 1', 'description': 'Rectus femoris thickness measured by ultrasound and expressed in centimeters.'}, {'measure': 'Vastus medialis thickness', 'timeFrame': 'Day 1', 'description': 'Vastus medialis thickness measured by ultrasound and expressed in centimeters.'}, {'measure': 'Vastus lateralis thickness', 'timeFrame': 'Day 1', 'description': 'Vastus lateralis thickness measured by ultrasound and expressed in centimeters.'}, {'measure': 'Vastus intermedius echogenicity', 'timeFrame': 'Day 1', 'description': 'Muscle echogenicity will be analyzed using ImageJ software and expressed as mean gray value.'}, {'measure': 'Rectus femoris echogenicity', 'timeFrame': 'Day 1', 'description': 'Muscle echogenicity will be analyzed using ImageJ software and expressed as mean grey value.'}, {'measure': 'Vastus medialis echogenicity', 'timeFrame': 'Day 1', 'description': 'Muscle echogenicity will be analyzed using ImageJ software and expressed as mean grey value.'}, {'measure': 'Vastus lateralis echogenicity', 'timeFrame': 'Day 1', 'description': 'Muscle echogenicity will be analyzed using ImageJ software and expressed as the mean gray value.'}, {'measure': 'Adipose tissue thickness', 'timeFrame': 'Day 1', 'description': 'Thickness of adipose tissue above quadriceps femoris muscle will be mesured by ultrasound and expressed in centimeters.'}, {'measure': 'Body mass index ˙(BMI)', 'timeFrame': 'Perioperative', 'description': "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)"}, {'measure': 'Length of mechanical ventilation', 'timeFrame': 'One month from admission to the ICU.', 'description': '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.\n\nWhether the patient is intubated again, these two ventilation times are added together.'}], 'secondaryOutcomes': [{'measure': 'Haemoglobin', 'timeFrame': 'Day 1', 'description': 'Haemoglobin levels (g/L) will be measured in the blood sample.'}, {'measure': 'Albumin', 'timeFrame': 'Day 1', 'description': 'The albumin level (g/L) will be measured in the blood sample.'}, {'measure': 'C-reactive protein (CRP)', 'timeFrame': 'Perioperative', 'description': 'C-reactive protein (CRP) is a protein produced by the liver and represents a key biomarker for systemic inflammation, infection, and tissue damage. CRP (mg/L) will be measured in blood sample.'}, {'measure': 'Lactate', 'timeFrame': 'Day 1', 'description': 'Lactate (mmol/L) is an energy source and a metabolic product produced in muscles, red blood cells, and the brain, during anaerobic metabolism. It acts as a marker for tissue oxygenation, with elevated blood levels indicating potential metabolic stress.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nutritional Status', 'Risk Assessment', 'Ultrasonography', 'Intensive Care Units', 'Postoperative Care'], 'conditions': ['Nutritional Status', 'Muscle Thickness of the Quadriceps Femoris', 'Frailty']}, 'referencesModule': {'references': [{'pmid': '35851996', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '38230231', 'type': 'BACKGROUND', 'citation': 'Xin 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.'}, {'pmid': '32384336', 'type': 'BACKGROUND', 'citation': 'De 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.'}, {'pmid': '37214110', 'type': 'BACKGROUND', 'citation': "Kalaiselvan 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."}, {'type': 'BACKGROUND', 'citation': 'Bakshi 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'}, {'pmid': '31976309', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '41010574', 'type': 'BACKGROUND', 'citation': 'Girgin 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.'}]}, 'descriptionModule': {'briefSummary': 'Ultrasound Indicators of Nutritional Status and Treatment Outcomes in Surgical Patients in the Intensive Care Unit', 'detailedDescription': "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 mentions the nutritional status and clinical frailty of patients as predictors of the duration and outcome of ICU treatment. The nutritional status (NS) of patients in intensive care units (ICUs) is assessed by clinical and laboratory indicators, including body mass index (BMI), clinical frailty score, hemoglobin, and albumin levels. It is quantified by rating scales such as NRS (Nutritional Risk Screening) and MUST (Malnutrition Universal Screening Tool).\n\nFrailty syndrome is defined as a patient's reduced capacity to tolerate changes in the physical, physiological, and cognitive aspects of body function. 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 one of the most important determinants in defining 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 in accordance with the above, determines the consumption of available resources. Assessment of patient frailty allows for adequate selection of therapeutic procedures and overall support for the patient with the aim of achieving optimal treatment outcome. Measuring patient frailty can be achieved using clinical scales, among which the most commonly used are the Clinical Frailty Scale (CSF) and the modified frailty index (mFI).\n\nUltrasound is a diagnostic tool that, due to its non-invasiveness and ease of performance, is increasingly used for the orientation assessment of the patient's condition and changes that occur 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.\n\nUltrasound has recently been used as a tool to assess the patient's nutritional status by measuring the thickness and intensity of muscle echogenicity, most often of the upper leg muscles, such as the quadriceps muscle. Muscle cross-sectional area and the thickness of the adipose tissue above it are often measured.\n\nStudies on nutritional status and its relationship with muscle echogenicity in the surgical patient population are rare.\n\nThe 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 in the study, the investigator will obtain informed consent from the patient or 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.\n\nDemographic 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 hospitalization in the intensive care unit, and time required to wean the patient from mechanical ventilation will be recorded. Patient frailty will be assessed during an interview with the patient. 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 into categories from 1, which indicates a very active, physically strong patient, to 9, which includes very sick patients who are 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 on a standard 5 \\* 5 mm area, equal for all images, using the ImageJ / Fiji computer program. 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)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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 and whether the procedure was emergency or elective.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* postoperative intensive care\n\nExclusion Criteria:\n\n* surgery of the right leg\n* paraplegia, tetraplegia\n* refusal of the patient/guardian to participate in the research (informed consent not signed)'}, 'identificationModule': {'nctId': 'NCT07475767', 'briefTitle': 'Ultrasound Indicators of Nutritional Status and Treatment Outcomes in Surgical Patients in the Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'Osijek University Hospital'}, 'officialTitle': 'Ultrasound Indicators of Nutritional Status and Treatment Outcomes in Surgical Patients in the Intensive Care Unit', 'orgStudyIdInfo': {'id': 'R1-13343'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Surgical patients in the intensive care unit', 'description': '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, and 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 in the study, the investigator will obtain informed consent from the patient or 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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '31000', 'city': 'Osijek', 'status': 'RECRUITING', 'country': 'Croatia', 'contacts': [{'name': 'Slavica Kvolik', 'role': 'CONTACT', 'email': 'skvolik@mefos.hr', 'phone': '098723925'}], 'facility': 'Osijek University Hospital; Medical Faculty', 'geoPoint': {'lat': 45.55066, 'lon': 18.6942}}], 'centralContacts': [{'name': 'Slavica Kvolik, prof.', 'role': 'CONTACT', 'email': 'skvolik@mefos.hr', 'phone': '098723925'}, {'name': 'Stjepan Juric, Prof', 'role': 'CONTACT', 'email': 'stjepan.juric@kbco.hr', 'phone': '+38531511511'}], 'overallOfficials': [{'name': 'Slavica Kvolik, prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Osijek University Hospital; Medical Faculty Osijek'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After study publication.', 'ipdSharing': 'YES', 'description': 'Yes, upon request sent to principal investigator', 'accessCriteria': 'Upon the reasonable request sent to principal investigator.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Osijek University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}