NCT05433831

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

25 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 27, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

June 27, 2022

Status Verified

June 1, 2022

Enrollment Period

5 months

First QC Date

June 16, 2022

Last Update Submit

June 22, 2022

Conditions

Keywords

UltrasonographyMalnutritionClinical NutritionDisease Related Malnutrition

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (32)

  • Sociodemographic data:

    Patients will be followed over a period of 6 consecutive months

  • Sociodemographic data:

    Patients will be followed over a period of 6 consecutive months

  • Sociodemographic data:

    Patients will be followed over a period of 6 consecutive months

  • Sociodemographic data:

    Patients will be followed over a period of 6 consecutive months

  • Sociodemographic data:

    Patients will be followed over a period of 6 consecutive months

  • +27 more secondary outcomes

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Servicio de Endocrinología y Nutrición. Complejo Hospitalario Universitario de Ferrol, A Coruña.

A Coruña, Spain

RECRUITING

Hospital Universitario de Badajoz

Badajoz, Spain

RECRUITING

Hospital Universitario Vall d´Hebron

Barcelona, Spain

RECRUITING

Hospital Universitario de Basurto

Bilbao, Spain

RECRUITING

Hospital Universitario Puerta del Mar

Cadiz, Spain

RECRUITING

Hospital Universitario Reina Sofía

Córdoba, Spain

RECRUITING

Hospital Universitario de Cabueñes

Gijón, Spain

RECRUITING

Hospital Universitario Virgen de las Nieves

Granada, Spain

RECRUITING

Hospital Universitario de Jaén

Jaén, Spain

RECRUITING

Complejo Hospitalario Uni. Insular - Materno Infantil

Las Palmas de Gran Canaria, Spain

RECRUITING

Hospital General Universitario Gregorio Marañón

Madrid, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, Spain

RECRUITING

Hospital Universitario de La Princesa

Madrid, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, Spain

RECRUITING

Clinical Management Unit of Endocrinology and Nutrition. Virgen de la Victoria Clinical Hospital, Málaga

Málaga, Spain

RECRUITING

UGC Endocrinología y Nutrición. Hospital Regional Universitario, Málaga.

Málaga, Spain

RECRUITING

Hospital Universitario de Navarra

Pamplona, Spain

RECRUITING

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Spain

RECRUITING

Hospital Universitario Marqués de Valdecilla

Santander, Spain

RECRUITING

Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, Spain

RECRUITING

Hospital Universitario Virgen del Rocío

Seville, Spain

RECRUITING

Hospital Universitario Virgen Macarena

Seville, Spain

RECRUITING

Hospital Clínico Universitario de Valencia

Valencia, Spain

RECRUITING

Hospital General Universitario de Valencia

Valencia, Spain

RECRUITING

Servicio de Endocrinología y Nutrición. Hospital Clínico Universitario de Valladolid, Valladolid.

Valladolid, Spain

RECRUITING

Related Publications (1)

  • Garcia Almeida JM, Bellido D, De Luis D, Guzman Rolo G, Olveira G. Protocol for a prospective cohort study on the 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). BMJ Open. 2023 Dec 9;13(12):e074945. doi: 10.1136/bmjopen-2023-074945.

MeSH Terms

Conditions

Nutrition DisordersMalnutrition

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Officials

  • José Manuel García Almeida, PhD

    Hospital Clínico Virgen de la Victoria, Málaga (España)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Núria Artigalàs Boixareu

CONTACT

Salvador López Agustina

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Management Unit of Endocrinology and Nutrition

Study Record Dates

First Submitted

June 16, 2022

First Posted

June 27, 2022

Study Start

January 1, 2022

Primary Completion

June 1, 2022

Study Completion

December 1, 2022

Last Updated

June 27, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations