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

NCT07475767 | Recruiting

• 1 other identifier: R1-13343
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nutritional Status; Muscle Thickness of the Quadriceps Femoris; Frailty

Keywords

Nutritional Status; Risk Assessment; Ultrasonography; Intensive Care Units; Postoperative Care

Outcome Measures

Primary Outcomes (13)

• Clinical Frailty Scale

  The Clinical Frailty Scale (CFS) is a 9-point, clinician-judgment tool assessing fitness-to-frailty (1=Very Fit, 9=Terminally Ill).

  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).

  Day 1

• Vastus intermedius thickness

  Vastus intermedius thickness measured by ultrasound and expressed in centimeters.

  Day 1

• Rectus femoris thickness

  Rectus femoris thickness measured by ultrasound and expressed in centimeters.

  Day 1

• Vastus medialis thickness

  Vastus medialis thickness measured by ultrasound and expressed in centimeters.

  Day 1

• Vastus lateralis thickness

  Vastus lateralis thickness measured by ultrasound and expressed in centimeters.

  Day 1

• Vastus intermedius echogenicity

  Muscle echogenicity will be analyzed using ImageJ software and expressed as mean gray value.

  Day 1

• Rectus femoris echogenicity

  Muscle echogenicity will be analyzed using ImageJ software and expressed as mean grey value.

  Day 1

• Vastus medialis echogenicity

  Muscle echogenicity will be analyzed using ImageJ software and expressed as mean grey value.

  Day 1

• Vastus lateralis echogenicity

  Muscle echogenicity will be analyzed using ImageJ software and expressed as the mean gray value.

  Day 1

• Adipose tissue thickness

  Thickness of adipose tissue above quadriceps femoris muscle will be mesured by ultrasound and expressed in centimeters.

  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)

  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.

  One month from admission to the ICU.

Secondary Outcomes (4)

• Haemoglobin

  Day 1

• Albumin

  Day 1

• C-reactive protein (CRP)

  Perioperative

• Lactate

  Day 1

Study Arms (1)

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, 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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 and whether the procedure was emergency or elective.

You may qualify if:

• postoperative intensive care

You may not qualify if:

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

Sponsors & Collaborators

• Osijek University Hospital: lead

Study Sites (1)

Osijek University Hospital; Medical Faculty

Osijek, 31000, Croatia

RECRUITING

Related Publications (7)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Slavica Kvolik, prof.

  Osijek University Hospital; Medical Faculty Osijek

  STUDY CHAIR

Central Study Contacts

Slavica Kvolik, prof.

CONTACT

098723925; skvolik@mefos.hr

Stjepan Juric, Prof

CONTACT

+38531511511; stjepan.juric@kbco.hr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 16, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After study publication.
• Access Criteria: Upon the reasonable request sent to principal investigator.

Locations

CR (1)