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

Malnutrition Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05433831
• Other study ID #: ALM-DRECO-2021-01
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: December 2022

Study information

• Verified date: June 2022
• Source: K Access Health Projects
• Contact: Núria Artigalàs Boixareu
• Phone: 610791607
• Email: nuriaartigalas[@]kaccesshealth.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Malnutrition
• Nutrition Disorders

Locations

Country	Name	City	State
Spain	Servicio de Endocrinología y Nutrición. Complejo Hospitalario Universitario de Ferrol, A Coruña.	A Coruña
Spain	Hospital Universitario de Badajoz	Badajoz
Spain	Hospital Universitario Vall d´Hebron	Barcelona
Spain	Hospital Universitario de Basurto	Bilbao
Spain	Hospital Universitario Puerta del Mar	Cadiz
Spain	Hospital Universitario Reina Sofía	Córdoba
Spain	Hospital Universitario de Cabueñes	Gijón
Spain	Hospital Universitario Virgen de las Nieves	Granada
Spain	Hospital Universitario de Jaén	Jaén
Spain	Complejo Hospitalario Uni. Insular - Materno Infantil	Las Palmas De Gran Canaria
Spain	Hospital General Universitario Gregorio Marañón	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario de La Princesa	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Clinical Management Unit of Endocrinology and Nutrition. Virgen de la Victoria Clinical Hospital, Málaga	Málaga
Spain	UGC Endocrinología y Nutrición. Hospital Regional Universitario, Málaga.	Málaga
Spain	Hospital Universitario de Navarra	Pamplona
Spain	Hospital Universitario de Canarias	Santa Cruz De Tenerife
Spain	Hospital Universitario Marqués de Valdecilla	Santander
Spain	Hospital Clínico Universitario de Santiago de Compostela	Santiago De Compostela
Spain	Hospital Universitario Virgen del Rocío	Sevilla
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	Hospital Clínico Universitario de Valencia	Valencia
Spain	Hospital General Universitario de Valencia	Valencia
Spain	Servicio de Endocrinología y Nutrición. Hospital Clínico Universitario de Valladolid, Valladolid.	Valladolid

Sponsors (2)

Lead Sponsor	Collaborator
K Access Health Projects	Abbott

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Sociodemographic data:	Age	Patients will be followed over a period of 6 consecutive months
Secondary	Sociodemographic data:	Sex	Patients will be followed over a period of 6 consecutive months
Secondary	Sociodemographic data:	Educational level	Patients will be followed over a period of 6 consecutive months
Secondary	Sociodemographic data:	Toxic habits	Patients will be followed over a period of 6 consecutive months
Secondary	Sociodemographic data:	Medical history	Patients will be followed over a period of 6 consecutive months
Secondary	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
Secondary	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
Secondary	Anthropometric data:	Current body weight (measured or estimated)	Patients will be followed over a period of 6 consecutive months
Secondary	Anthropometric data:	Usual weight	Patients will be followed over a period of 6 consecutive months
Secondary	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
Secondary	Anthropometric data:	Height (measured or estimated)	Patients will be followed over a period of 6 consecutive months
Secondary	Anthropometric data:	BMI (body mass index)	Patients will be followed over a period of 6 consecutive months
Secondary	Anthropometric data:	Arm circumference	Patients will be followed over a period of 6 consecutive months
Secondary	Bioelectrical impedance data (model (50 kHz):	TBW (total body water, L),	Patients will be followed over a period of 6 consecutive months
Secondary	Bioelectrical impedance data (model (50 kHz):	ECW (extracellular water, L),	Patients will be followed over a period of 6 consecutive months
Secondary	Bioelectrical impedance data (model (50 kHz):	ICW (intracellular water, L),	Patients will be followed over a period of 6 consecutive months
Secondary	Bioelectrical impedance data (model (50 kHz):	FFM (lean mass, kg),	Patients will be followed over a period of 6 consecutive months
Secondary	Bioelectrical impedance data (model (50 kHz):	FM (fat mass, kg),	Patients will be followed over a period of 6 consecutive months
Secondary	Bioelectrical impedance data (model (50 kHz):	BCM (body cell mass, kg),	Patients will be followed over a period of 6 consecutive months
Secondary	Bioelectrical impedance data (model (50 kHz):	ASMM (appendicular skeletal muscle mass, kg),	Patients will be followed over a period of 6 consecutive months
Secondary	Bioelectrical impedance data (model (50 kHz):	SMI (skeletal muscle mass index, kg),	Patients will be followed over a period of 6 consecutive months
Secondary	Bioelectrical impedance data (model (50 kHz):	Percent hydration.	Patients will be followed over a period of 6 consecutive months
Secondary	Bioelectrical impedance data (model (50 kHz):	% body fat	Patients will be followed over a period of 6 consecutive months
Secondary	Blood biochemistry data (at baseline visit, at 3 and 6 months):	albumin	Patients will be followed over a period of 6 consecutive months
Secondary	Blood biochemistry data (at baseline visit, at 3 and 6 months):	prealbumin	Patients will be followed over a period of 6 consecutive months
Secondary	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
Secondary	Blood biochemistry data (at baseline visit, at 3 and 6 months):	total cholesterol	Patients will be followed over a period of 6 consecutive months
Secondary	Blood biochemistry data (at baseline visit, at 3 and 6 months):	lymphocytes	Patients will be followed over a period of 6 consecutive months
Secondary	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
Secondary	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
Secondary	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
Secondary	Adherence.	Attendance to study follow-up visits.	Patients will be followed over a period of 6 consecutive months