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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Nutrition Disorders
- Sponsor
- K Access Health Projects
- Enrollment
- 1000
- Locations
- 25
- Primary Endpoint
- Nutritional ultrasound measurements: ultrasound with 4-10 cm linear probe.
- Last Updated
- 3 years ago
Overview
Brief Summary
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
Prospective, multicenter, uncontrolled clinical study, of routine clinical practice, without drugs or medical devices
Investigators
Dr. José Manuel García Almeida
Clinical Management Unit of Endocrinology and Nutrition
Hospital Universitario Virgen de la Victoria
Eligibility Criteria
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) ≥
- •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.
Outcomes
Primary Outcomes
Nutritional ultrasound measurements: ultrasound with 4-10 cm linear probe.
Time Frame: Patients will be followed over a period of 6 consecutive months
* Abdominal ultrasound: total, superficial and pre-peritoneal adipose tissue (measured in centimetres). * Muscle ultrasound: Area, circumference, axes and adipose tissue (measured in centimetres)
Secondary Outcomes
- Subjective Global Assessment (SGA)(Patients will be followed over a period of 6 consecutive months)
- Anthropometric data:(Patients will be followed over a period of 6 consecutive months)
- Blood biochemistry data (at baseline visit, at 3 and 6 months):(Patients will be followed over a period of 6 consecutive months)
- Functional parameters:(Patients will be followed over a period of 6 consecutive months)
- Sociodemographic data:(Patients will be followed over a period of 6 consecutive months)
- Bioelectrical impedance data (model (50 kHz):(Patients will be followed over a period of 6 consecutive months)
- Current patient status:(Patients will be followed over a period of 6 consecutive months)
- Adherence.(Patients will be followed over a period of 6 consecutive months)