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:
Osijek University Hospital
Organization:
Study Overview
Official Title:
Ultrasound Indicators of Nutritional Status and Treatment Outcomes in Surgical Patients in the Intensive Care Unit
Status:
RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 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).
Frailty 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).
Ultrasound 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.
Ultrasound 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.
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 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.
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 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).
Frailty 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).
Ultrasound 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.
Ultrasound 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.
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 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.
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 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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: