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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05433831
Enrollment
1000
Registered
2022-06-27
Start date
2022-01-01
Completion date
2022-12-31
Last updated
2022-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malnutrition, Nutrition Disorders

Keywords

Ultrasonography, Malnutrition, Clinical Nutrition, Disease Related Malnutrition

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

Interventions

None listed

Sponsors

K Access Health Projects
Lead SponsorOTHER
Abbott
CollaboratorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Nutritional ultrasound measurements: ultrasound with 4-10 cm linear probe.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

MeasureTime frameDescription
Sociodemographic data:Patients will be followed over a period of 6 consecutive monthsAge
Subjective Global Assessment (SGA)Patients will be followed over a period of 6 consecutive monthsSGA 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.
Anthropometric data:Patients will be followed over a period of 6 consecutive monthsCurrent body weight (measured or estimated)
Adherence.Patients will be followed over a period of 6 consecutive monthsAttendance to study follow-up visits.
Blood biochemistry data (at baseline visit, at 3 and 6 months):Patients will be followed over a period of 6 consecutive monthsalbumin
Functional parameters:Patients will be followed over a period of 6 consecutive monthsTimed 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.
Current patient status:Patients will be followed over a period of 6 consecutive monthsHospital 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.
Bioelectrical impedance data (model (50 kHz):Patients will be followed over a period of 6 consecutive monthsTBW (total body water, L),

Countries

Spain

Contacts

Primary ContactNúria Artigalàs Boixareu
nuriaartigalas@kaccesshealth.com610791607
Backup ContactSalvador López Agustina
salvalopez@kaccesshealth.com670462120

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026