Clinical trial NCT05433831: Application of Nutritional Ultrasound in the Diagnosis and Follow-up of Patients With Nutritional Risk: DRECO Study
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nutrition Disorders
Malnutrition
Keywords: Ultrasonography
Malnutrition
Clinical Nutrition
Disease Related Malnutrition
Lead sponsor: K Access Health Projects
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2022-06-27
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 18 years of age who, in the first week of hospital admission in medical-surgical areas, excluding critical patients, have an assessment of risk of malnutrition according to the MUST/SARC-F (R-MAPP) screening test, will be included.

If the results show a moderate or high risk of malnutrition, these patients will be invited to participate in the study, and will undergo the morphofunctional assessment, an ultrasound study and the subjective global assessment (SGA).

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

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) ≥ 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.

Primary outcomes:
measure: Nutritional ultrasound measurements: ultrasound with 4-10 cm linear probe.
timeFrame: Patients will be followed over a period of 6 consecutive months
Secondary outcomes:
measure: Sociodemographic data:
timeFrame: Patients will be followed over a period of 6 consecutive months
measure: Sociodemographic data:
timeFrame: Patients will be followed over a period of 6 consecutive months
measure: Sociodemographic data:
timeFrame: Patients will be followed over a period of 6 consecutive months
measure: Sociodemographic data:
timeFrame: Patients will be followed over a period of 6 consecutive months
measure: Sociodemographic data:
timeFrame: Patients will be followed over a period of 6 consecutive months
measure: Sociodemographic data:
timeFrame: Patients will be followed over a period of 6 consecutive months
measure: Subjective Global Assessment (SGA)
timeFrame: Patients will be followed over a period of 6 consecutive months
measure: Anthropometric data:
timeFrame: Patients will be followed over a period of 6 consecutive months
measure: Anthropometric data:
timeFrame: Patients will be followed over a period of 6 consecutive months
measure: Anthropometric data:
timeFrame: Patients will be followed over a period of 6 consecutive months
measure: Anthropometric data:
timeFrame: Patients will be followed over a period of 6 consecutive months
measure: Anthropometric data:
timeFrame: Patients will be followed over a period of 6 consecutive months
measure: Anthropometric data:
timeFrame: Patients will be followed over a period of 6 consecutive months
measure: Bioelectrical impedance data (model (50 kHz):
timeFrame: Patients will be followed over a period of 6 consecutive months
measure: Bioelectrical impedance data (model (50 kHz):
timeFrame: Patients will be followed over a period of 6 consecutive months
measure: Bioelectrical impedance data (model (50 kHz):
timeFrame: Patients will be followed over a period of 6 consecutive months
measure: Bioelectrical impedance data (model (50 kHz):
timeFrame: Patients will be followed over a period of 6 consecutive months
measure: Bioelectrical impedance data (model (50 kHz):
timeFrame: Patients will be followed over a period of 6 consecutive months
measure: Bioelectrical impedance data (model (50 kHz):
timeFrame: Patients will be followed over a period of 6 consecutive months
measure: Bioelectrical impedance data (model (50 kHz):
timeFrame: Patients will be followed over a period of 6 consecutive months
measure: Bioelectrical impedance data (model (50 kHz):
timeFrame: Patients will be followed over a period of 6 consecutive months
measure: Bioelectrical impedance data (model (50 kHz):
timeFrame: Patients will be followed over a period of 6 consecutive months
measure: Bioelectrical impedance data (model (50 kHz):
timeFrame: Patients will be followed over a period of 6 consecutive months
measure: Blood biochemistry data (at baseline visit, at 3 and 6 months):
timeFrame: Patients will be followed over a period of 6 consecutive months
measure: Blood biochemistry data (at baseline visit, at 3 and 6 months):
timeFrame: Patients will be followed over a period of 6 consecutive months
measure: Blood biochemistry data (at baseline visit, at 3 and 6 months):
timeFrame: Patients will be followed over a period of 6 consecutive months
measure: Blood biochemistry data (at baseline visit, at 3 and 6 months):
timeFrame: Patients will be followed over a period of 6 consecutive months
measure: Blood biochemistry data (at baseline visit, at 3 and 6 months):
timeFrame: Patients will be followed over a period of 6 consecutive months
measure: Functional parameters:
timeFrame: Patients will be followed over a period of 6 consecutive months
measure: Functional parameters:
timeFrame: Patients will be followed over a period of 6 consecutive months
measure: Current patient status:
timeFrame: Patients will be followed over a period of 6 consecutive months
measure: Adherence.
timeFrame: Patients will be followed over a period of 6 consecutive months
Other outcomes:
Locations:
city: A Coruña
country: Spain
facility: Servicio de Endocrinología y Nutrición. Complejo Hospitalario Universitario de Ferrol, A Coruña.
city: Badajoz
country: Spain
facility: Hospital Universitario de Badajoz
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d´Hebron
city: Bilbao
country: Spain
facility: Hospital Universitario de Basurto
city: Cadiz
country: Spain
facility: Hospital Universitario Puerta del Mar
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Gijón
country: Spain
facility: Hospital Universitario de Cabueñes
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Jaén
country: Spain
facility: Hospital Universitario de Jaén
city: Las Palmas De Gran Canaria
country: Spain
facility: Complejo Hospitalario Uni. Insular - Materno Infantil
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Málaga
country: Spain
facility: Clinical Management Unit of Endocrinology and Nutrition. Virgen de la Victoria Clinical Hospital, Málaga
city: Málaga
country: Spain
facility: UGC Endocrinología y Nutrición. Hospital Regional Universitario, Málaga.
city: Pamplona
country: Spain
facility: Hospital Universitario de Navarra
city: Santa Cruz De Tenerife
country: Spain
facility: Hospital Universitario de Canarias
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Santiago De Compostela
country: Spain
facility: Hospital Clínico Universitario de Santiago de Compostela
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Valladolid
country: Spain
facility: Servicio de Endocrinología y Nutrición. Hospital Clínico Universitario de Valladolid, Valladolid.
Study officials:
affiliation: Hospital Clínico Virgen de la Victoria, Málaga (España)
name: José Manuel García Almeida, PhD
role: PRINCIPAL_INVESTIGATOR
References: