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

NCT ID: NCT05433831

Last Updated: 2022-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-12-31

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

Conditions

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Nutrition Disorders Malnutrition

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role collaborator

K Access Health Projects

OTHER

Sponsor Role lead

Responsible Party

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Dr. José Manuel García Almeida

Clinical Management Unit of Endocrinology and Nutrition

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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José Manuel García Almeida, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clínico Virgen de la Victoria, Málaga (España)

Locations

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

A Coruña, , Spain

Site Status RECRUITING

Hospital Universitario de Badajoz

Badajoz, , Spain

Site Status RECRUITING

Hospital Universitario Vall d´Hebron

Barcelona, , Spain

Site Status RECRUITING

Hospital Universitario de Basurto

Bilbao, , Spain

Site Status RECRUITING

Hospital Universitario Puerta del Mar

Cadiz, , Spain

Site Status RECRUITING

Hospital Universitario Reina Sofía

Córdoba, , Spain

Site Status RECRUITING

Hospital Universitario de Cabueñes

Gijón, , Spain

Site Status RECRUITING

Hospital Universitario Virgen de las Nieves

Granada, , Spain

Site Status RECRUITING

Hospital Universitario de Jaén

Jaén, , Spain

Site Status RECRUITING

Complejo Hospitalario Uni. Insular - Materno Infantil

Las Palmas de Gran Canaria, , Spain

Site Status RECRUITING

Hospital General Universitario Gregorio Marañón

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario de La Princesa

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario La Paz

Madrid, , Spain

Site Status RECRUITING

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

Málaga, , Spain

Site Status RECRUITING

UGC Endocrinología y Nutrición. Hospital Regional Universitario, Málaga.

Málaga, , Spain

Site Status RECRUITING

Hospital Universitario de Navarra

Pamplona, , Spain

Site Status RECRUITING

Hospital Universitario de Canarias

Santa Cruz de Tenerife, , Spain

Site Status RECRUITING

Hospital Universitario Marqués de Valdecilla

Santander, , Spain

Site Status RECRUITING

Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, , Spain

Site Status RECRUITING

Hospital Universitario Virgen del Rocío

Seville, , Spain

Site Status RECRUITING

Hospital Universitario Virgen Macarena

Seville, , Spain

Site Status RECRUITING

Hospital Clínico Universitario de Valencia

Valencia, , Spain

Site Status RECRUITING

Hospital General Universitario de Valencia

Valencia, , Spain

Site Status RECRUITING

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

Valladolid, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Núria Artigalàs Boixareu

Role: CONTACT

610791607

Salvador López Agustina

Role: CONTACT

670462120

Facility Contacts

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Diego Bellido Guerrero, Ph

Role: primary

Luis Miguel Luengo Pérez, Ph

Role: primary

Rosa Burgos Peláez, Ph

Role: primary

Natalia Covadonga Iglesias Hernández, Ph

Role: primary

Francisco Javier Vílchez López, Ph

Role: primary

María José Molina Puerta, Ph

Role: primary

María Riestra Fernández, Ph

Role: primary

Juan Manuel Guardia Baena, Ph

Role: primary

María Josefa Martínez Ramírez, Ph

Role: primary

Inmaculada Prior Sánchez, Ph

Role: backup

Yaiza García Delgado, Ph

Role: primary

Irene Bretón Lesmes, Ph

Role: primary

María Maíz Jiménez, Ph

Role: primary

Begoña Molina Baena, Ph

Role: primary

Samara Palma Milla, Ph

Role: primary

José Manuel García Almeida

Role: primary

+34 646314182

Gabriel Olveira Fuster, Ph

Role: primary

Henry Rendón Barragán, Ph

Role: primary

Tomás Martín Folgueras, Ph

Role: primary

Coral Montalbán Carrasco, Ph

Role: primary

Miguel Ángel Martínez Olmos, Ph

Role: primary

Pedro Pablo García Luna, Ph

Role: primary

Juana María Rabat Restrepo, Ph

Role: primary

Miguel Civera Andrés, Ph

Role: primary

Carlos Sánchez Juan, Ph

Role: primary

Daniel de Luís Román, Ph

Role: primary

References

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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.

Reference Type DERIVED
PMID: 38070895 (View on PubMed)

Other Identifiers

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ALM-DRECO-2021-01

Identifier Type: -

Identifier Source: org_study_id

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