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

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.

Study Overview

• Status: Recruiting
• Conditions: Nutrition Disorders; Malnutrition

Detailed Description

Prospective, multicenter, uncontrolled clinical study, of routine clinical practice, without drugs or medical devices

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Núria Artigalàs Boixareu; Phone Number: 610791607; Email: nuriaartigalas@kaccesshealth.com
• Study Contact Backup: Name: Salvador López Agustina; Phone Number: 670462120; Email: salvalopez@kaccesshealth.com

Study Locations

• Spain
  • A Coruña, Spain
    • Recruiting
    • Servicio de Endocrinología y Nutrición. Complejo Hospitalario Universitario de Ferrol, A Coruña.
    • Contact: Diego Bellido Guerrero, Ph; Email: diegobellido@gmail.com
    • Sub-Investigator: Diego Bellido Guerrero, Ph
  • Badajoz, Spain
    • Recruiting
    • Hospital Universitario de Badajoz
    • Contact: Luis Miguel Luengo Pérez, Ph
  • Barcelona, Spain
    • Recruiting
    • Hospital Universitario Vall d´Hebron
    • Contact: Rosa Burgos Peláez, Ph
  • Bilbao, Spain
    • Recruiting
    • Hospital Universitario de Basurto
    • Contact: Natalia Covadonga Iglesias Hernández, Ph
  • Cadiz, Spain
    • Recruiting
    • Hospital Universitario Puerta Del Mar
    • Contact: Francisco Javier Vílchez López, Ph
  • Córdoba, Spain
    • Recruiting
    • Hospital Universitario Reina Sofia
    • Contact: María José Molina Puerta, Ph
  • Gijón, Spain
    • Recruiting
    • Hospital Universitario de Cabueñes
    • Contact: María Riestra Fernández, Ph
  • Granada, Spain
    • Recruiting
    • Hospital Universitario Virgen de las Nieves
    • Contact: Juan Manuel Guardia Baena, Ph
  • Jaén, Spain
    • Recruiting
    • Hospital Universitario de Jaen
    • Contact: María Josefa Martínez Ramírez, Ph
    • Contact: Inmaculada Prior Sánchez, Ph
  • Las Palmas De Gran Canaria, Spain
    • Recruiting
    • Complejo Hospitalario Uni. Insular - Materno Infantil
    • Contact: Yaiza García Delgado, Ph
  • Madrid, Spain
    • Recruiting
    • Hospital Universitario 12 de Octubre
    • Contact: María Maíz Jiménez, Ph
  • Madrid, Spain
    • Recruiting
    • Hospital General Universitario Gregorio Marañón
    • Contact: Irene Bretón Lesmes, Ph
  • Madrid, Spain
    • Recruiting
    • Hospital Universitario La Paz
    • Contact: Samara Palma Milla, Ph
  • Madrid, Spain
    • Recruiting
    • Hospital Universitario De La Princesa
    • Contact: Begoña Molina Baena, Ph
  • Málaga, Spain
    • Recruiting
    • Clinical Management Unit of Endocrinology and Nutrition. Virgen de la Victoria Clinical Hospital, Málaga
    • Contact: José Manuel García Almeida; Phone Number: +34 646314182; Email: jgarcialameida@gmail.com
    • Principal Investigator: José Manuel García Almeida, Ph
  • Málaga, Spain
    • Recruiting
    • UGC Endocrinología y Nutrición. Hospital Regional Universitario, Málaga.
    • Contact: Gabriel Olveira Fuster, Ph; Email: gabrielolveiracasa@gmail.com
    • Sub-Investigator: Gabriel Olveira Fuster, Ph
  • Pamplona, Spain
    • Recruiting
    • Hospital Universitario de Navarra
    • Contact: Henry Rendón Barragán, Ph
  • Santa Cruz De Tenerife, Spain
    • Recruiting
    • Hospital Universitario de Canarias
    • Contact: Tomás Martín Folgueras, Ph
  • Santander, Spain
    • Recruiting
    • Hospital Universitario Marques de Valdecilla
    • Contact: Coral Montalbán Carrasco, Ph
  • Santiago De Compostela, Spain
    • Recruiting
    • Hospital Clinico Universitario de Santiago de Compostela
    • Contact: Miguel Ángel Martínez Olmos, Ph
  • Sevilla, Spain
    • Recruiting
    • Hospital Universitario Virgen del Rocio
    • Contact: Pedro Pablo García Luna, Ph
  • Sevilla, Spain
    • Recruiting
    • Hospital Universitario Virgen Macarena
    • Contact: Juana María Rabat Restrepo, Ph
  • Valencia, Spain
    • Recruiting
    • Hospital General Universitario de Valencia
    • Contact: Carlos Sánchez Juan, Ph
  • Valencia, Spain
    • Recruiting
    • Hospital Clinico Universitario de Valencia
    • Contact: Miguel Civera Andrés, Ph
  • Valladolid, Spain
    • Recruiting
    • Servicio de Endocrinología y Nutrición. Hospital Clínico Universitario de Valladolid, Valladolid.
    • Contact: Daniel de Luís Román, Ph; Email: dadluis@yahoo.es
    • Sub-Investigator: Daniel de Luís Román, Ph

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sociodemographic data:	Age	Patients will be followed over a period of 6 consecutive months
Sociodemographic data:	Sex	Patients will be followed over a period of 6 consecutive months
Sociodemographic data:	Educational level	Patients will be followed over a period of 6 consecutive months
Sociodemographic data:	Toxic habits	Patients will be followed over a period of 6 consecutive months
Sociodemographic data:	Medical history	Patients will be followed over a period of 6 consecutive months
Sociodemographic data:	Risk of sarcopenia and moderate to high malnutrition based on MUST and SARC-F screening test using R-MAPP.	Patients will be followed over a period of 6 consecutive months
Subjective Global Assessment (SGA)	SGA 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.	Patients will be followed over a period of 6 consecutive months
Anthropometric data:	Current body weight (measured or estimated)	Patients will be followed over a period of 6 consecutive months
Anthropometric data:	Usual weight	Patients will be followed over a period of 6 consecutive months
Anthropometric data:	Adjusted weight (adjusted weight in obese subjects, dry weight without oedema in malnourished subjects)	Patients will be followed over a period of 6 consecutive months
Anthropometric data:	Height (measured or estimated)	Patients will be followed over a period of 6 consecutive months
Anthropometric data:	BMI (body mass index)	Patients will be followed over a period of 6 consecutive months
Anthropometric data:	Arm circumference	Patients will be followed over a period of 6 consecutive months
Bioelectrical impedance data (model (50 kHz):	TBW (total body water, L),	Patients will be followed over a period of 6 consecutive months
Bioelectrical impedance data (model (50 kHz):	ECW (extracellular water, L),	Patients will be followed over a period of 6 consecutive months
Bioelectrical impedance data (model (50 kHz):	ICW (intracellular water, L),	Patients will be followed over a period of 6 consecutive months
Bioelectrical impedance data (model (50 kHz):	FFM (lean mass, kg),	Patients will be followed over a period of 6 consecutive months
Bioelectrical impedance data (model (50 kHz):	FM (fat mass, kg),	Patients will be followed over a period of 6 consecutive months
Bioelectrical impedance data (model (50 kHz):	BCM (body cell mass, kg),	Patients will be followed over a period of 6 consecutive months
Bioelectrical impedance data (model (50 kHz):	ASMM (appendicular skeletal muscle mass, kg),	Patients will be followed over a period of 6 consecutive months
Bioelectrical impedance data (model (50 kHz):	SMI (skeletal muscle mass index, kg),	Patients will be followed over a period of 6 consecutive months
Bioelectrical impedance data (model (50 kHz):	Percent hydration.	Patients will be followed over a period of 6 consecutive months
Bioelectrical impedance data (model (50 kHz):	% body fat	Patients will be followed over a period of 6 consecutive months
Blood biochemistry data (at baseline visit, at 3 and 6 months):	albumin	Patients will be followed over a period of 6 consecutive months
Blood biochemistry data (at baseline visit, at 3 and 6 months):	prealbumin	Patients will be followed over a period of 6 consecutive months
Blood biochemistry data (at baseline visit, at 3 and 6 months):	C-reactive protein	Patients will be followed over a period of 6 consecutive months
Blood biochemistry data (at baseline visit, at 3 and 6 months):	total cholesterol	Patients will be followed over a period of 6 consecutive months
Blood biochemistry data (at baseline visit, at 3 and 6 months):	lymphocytes	Patients will be followed over a period of 6 consecutive months
Functional parameters:	Timed 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.	Patients will be followed over a period of 6 consecutive months
Functional parameters:	Dynamometry. Three measurements of the dominant hand will be made recording the mean and maximum, measured in kilograms. Jamar® dynamometers are most used in international studies and have several grip positions.	Patients will be followed over a period of 6 consecutive months
Current patient status:	Hospital 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.	Patients will be followed over a period of 6 consecutive months
Adherence.	Attendance to study follow-up visits.	Patients will be followed over a period of 6 consecutive months

Collaborators and Investigators

• Sponsor: K Access Health Projects
• Collaborators: Abbott
• Investigators: Principal Investigator: José Manuel García Almeida, PhD, Hospital Clínico Virgen de la Victoria, Málaga (España)

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2022
• Primary Completion (ANTICIPATED): June 1, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: June 16, 2022
• First Submitted That Met QC Criteria: June 22, 2022
• First Posted (ACTUAL): June 27, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 27, 2022
• Last Update Submitted That Met QC Criteria: June 22, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Ultrasonography; Malnutrition; Clinical Nutrition; Disease Related Malnutrition
• Additional Relevant MeSH Terms: Malnutrition; Nutrition Disorders
• Other Study ID Numbers: ALM-DRECO-2021-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No