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Идёт набор NCT07475767

Ultrasound, Nutritional Status, and Outcomes in Surgical ICU

Наблюдательное Nutritional Status Muscle Thickness of the Quadriceps Femoris Frailty

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Nutritional Status, Muscle Thickness of the Quadriceps Femoris, Frailty. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Хорватия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Ultrasound Indicators of Nutritional Status and Treatment Outcomes in Surgical Patients in the Intensive Care Unit

Обзор

Ultrasound Indicators of Nutritional Status and Treatment Outcomes in Surgical Patients in the Intensive Care Unit

Подробное описание

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).

Первичные конечные точки

  • Clinical Frailty Scale [Срок оценки: Day 1 (within 24 hours from admission to the intensive care unit)]
  • Nutritional Risk Screening 2002 [Срок оценки: Day 1]
  • Vastus intermedius thickness [Срок оценки: Day 1]
  • Rectus femoris thickness [Срок оценки: Day 1]
  • Vastus medialis thickness [Срок оценки: Day 1]
  • Vastus lateralis thickness [Срок оценки: Day 1]
  • Vastus intermedius echogenicity [Срок оценки: Day 1]
  • Rectus femoris echogenicity [Срок оценки: Day 1]
  • Vastus medialis echogenicity [Срок оценки: Day 1]
  • Vastus lateralis echogenicity [Срок оценки: Day 1]
Вторичные конечные точки (4)
  • Haemoglobin [Срок оценки: Day 1]
  • Albumin [Срок оценки: Day 1]
  • C-reactive protein (CRP) [Срок оценки: Perioperative]
  • Lactate [Срок оценки: Day 1]

Критерии участия

Критерии включения

  • postoperative intensive care

Критерии исключения

  • surgery of the right leg
  • paraplegia, tetraplegia
  • refusal of the patient/guardian to participate in the research (informed consent not signed)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Хорватия · 1 центр
  • Osijek University Hospital; Medical Faculty — Osijek

Публикации

  • 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 35851996
  • 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 38230231
  • 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 32384336
  • 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. PMID 37214110
  • 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
  • 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 31976309
  • 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. PMID 41010574

Идентификаторы

NCT: NCT07475767 · R1-13343

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗