Application of Nutritional Ultrasound in the Diagnosis and Follow-up of Patients With Nutritional Risk: DRECO Study

Study Overview
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Brief Summary
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Disease-related malnutrition (DRM) can occur when there is a deficient supply of energy, protein and/or other nutrients, depending on the nutritional needs of each individual at different times of their life cycle or health or disease circumstances. This deficiency induces effects on body composition and tissue and organ function and results in clinical consequences: increased morbidity and mortality associated with different disease processes. There are techniques for nutritional assessment using assessment tools aimed at morphofunctional diagnosis of malnutrition, in addition to the classical nutritional parameters, such as weight loss, BMI, folds, circumferences, albumin, lymphocytes, cholesterol and intake. New advanced parameters are being incorporated into clinical nutrition and their incorporation into clinical practice is of increasing interest, such as measures derived from bioelectrical impedance (BIA) and phase angle (PhA), dynamometry, functional tests, CRP/prealbumin ratio and muscle ultrasound. In 2019, the GLIM criteria were published, providing a different vision of how to assess the malnourished patient. Phenotypic criteria include reduction in muscle mass (measured using validated techniques to measure body composition). The objective of the study is to highlight nutritional ultrasound for measuring muscle and functional status in order to make a more accurate diagnosis and a better prediction of complications and morbidity and mortality in this type of patients.

Detailed Description
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Prospective, multicenter, uncontrolled clinical study, of routine clinical practice, without drugs or medical devices

Official Title
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Feasibility of Application of Nutritional Ultrasound in the Diagnosis and Follow-up of Patients With Nutritional Risk at Hospital Discharge: Study on Body Composition and Function: DRECO Study

Conditions
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Nutrition Disorders, Malnutrition

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients admitted to hospital who in the first week of admission have moderate or high risk of malnutrition according to the MUST and SARC-F screening test using R-MAPP. Appendix Patient aged 18 to 85 years. Patient who agrees to participate in the study and signs the informed consent. Exclusion Criteria: Hepatic impairment (AST/ALT 3 x upper limit of normal) Chronic kidney failure (GFR <45 mL/min) Patient with previous ICU stay during the study admission. Cancer patients on palliative treatment or ECOG (Eastern Cooperative Oncology Group) ≥ 3. Orthopaedic disease that does not allow adequate walking Patients with known dementia or others not related to a significant neurological or psychiatric disorder, or any other psychological condition that may interfere with the conduct of the study. Patients with eating disorders Life expectancy of less than 6 months. Patients unable to adequately complete the clinical laboratory assessments required for the study protocol.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional ultrasound measurements: ultrasound with 4-10 cm linear probe. | Abdominal ultrasound: total, superficial and pre-peritoneal adipose tissue (measured in centimetres). Muscle ultrasound: Area, circumference, axes and adipose tissue (measured in centimetres) | Patients will be followed over a period of 6 consecutive months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sociodemographic data: | Age | Patients will be followed over a period of 6 consecutive months | 
| Sociodemographic data: | Sex | Patients will be followed over a period of 6 consecutive months | 
| Sociodemographic data: | Educational level | Patients will be followed over a period of 6 consecutive months | 
| Sociodemographic data: | Toxic habits | Patients will be followed over a period of 6 consecutive months | 
| Sociodemographic data: | Medical history | Patients will be followed over a period of 6 consecutive months | 
| Sociodemographic data: | Risk of sarcopenia and moderate to high malnutrition based on MUST and SARC-F screening test using R-MAPP. | Patients will be followed over a period of 6 consecutive months | 
| Subjective Global Assessment (SGA) | SGA questionnaire. SGA rank indicates the patient's nutritional status according to 3 categories: (1) well nourished, (2) moderate or suspected malnutrition, and (3) severe malnutrition. | Patients will be followed over a period of 6 consecutive months | 
| Anthropometric data: | Current body weight (measured or estimated) | Patients will be followed over a period of 6 consecutive months | 
| Anthropometric data: | Usual weight | Patients will be followed over a period of 6 consecutive months | 
| Anthropometric data: | Adjusted weight (adjusted weight in obese subjects, dry weight without oedema in malnourished subjects) | Patients will be followed over a period of 6 consecutive months | 
| Anthropometric data: | Height (measured or estimated) | Patients will be followed over a period of 6 consecutive months | 
| Anthropometric data: | BMI (body mass index) | Patients will be followed over a period of 6 consecutive months | 
| Anthropometric data: | Arm circumference | Patients will be followed over a period of 6 consecutive months | 
| Bioelectrical impedance data (model (50 kHz): | TBW (total body water, L), | Patients will be followed over a period of 6 consecutive months | 
| Bioelectrical impedance data (model (50 kHz): | ECW (extracellular water, L), | Patients will be followed over a period of 6 consecutive months | 
| Bioelectrical impedance data (model (50 kHz): | ICW (intracellular water, L), | Patients will be followed over a period of 6 consecutive months | 
| Bioelectrical impedance data (model (50 kHz): | FFM (lean mass, kg), | Patients will be followed over a period of 6 consecutive months | 
| Bioelectrical impedance data (model (50 kHz): | FM (fat mass, kg), | Patients will be followed over a period of 6 consecutive months | 
| Bioelectrical impedance data (model (50 kHz): | BCM (body cell mass, kg), | Patients will be followed over a period of 6 consecutive months | 
| Bioelectrical impedance data (model (50 kHz): | ASMM (appendicular skeletal muscle mass, kg), | Patients will be followed over a period of 6 consecutive months | 
| Bioelectrical impedance data (model (50 kHz): | SMI (skeletal muscle mass index, kg), | Patients will be followed over a period of 6 consecutive months | 
| Bioelectrical impedance data (model (50 kHz): | Percent hydration. | Patients will be followed over a period of 6 consecutive months | 
| Bioelectrical impedance data (model (50 kHz): | % body fat | Patients will be followed over a period of 6 consecutive months | 
| Blood biochemistry data (at baseline visit, at 3 and 6 months): | albumin | Patients will be followed over a period of 6 consecutive months | 
| Blood biochemistry data (at baseline visit, at 3 and 6 months): | prealbumin | Patients will be followed over a period of 6 consecutive months | 
| Blood biochemistry data (at baseline visit, at 3 and 6 months): | C-reactive protein | Patients will be followed over a period of 6 consecutive months | 
| Blood biochemistry data (at baseline visit, at 3 and 6 months): | total cholesterol | Patients will be followed over a period of 6 consecutive months | 
| Blood biochemistry data (at baseline visit, at 3 and 6 months): | lymphocytes | Patients will be followed over a period of 6 consecutive months | 
| Functional parameters: | Timed Up and Go test (TUG): patient sits in a chair and is told to get up (timing starts), walks 3 meters, comes back and sits in the initial chair (timing ends). Interpretation: <20 seconds: normal,> 20 seconds: increased risk of falling. | Patients will be followed over a period of 6 consecutive months | 
| Functional parameters: | Dynamometry. Three measurements of the dominant hand will be made recording the mean and maximum, measured in kilograms. Jamar® dynamometers are most used in international studies and have several grip positions. | Patients will be followed over a period of 6 consecutive months | 
| Current patient status: | Hospital stay, mortality at 3 and 6 months, hospital readmissions and complications. The complications occurring and their consequences (resolved/unresolved) must be recorded in the form. | Patients will be followed over a period of 6 consecutive months | 
| Adherence. | Attendance to study follow-up visits. | Patients will be followed over a period of 6 consecutive months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ultrasonography, Malnutrition, Clinical Nutrition, Disease Related Malnutrition