Application of Nutritional Ultrasound in the Diagnosis and Follow-up of Patients With Nutritional Risk: DRECO Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
Prospective, multicenter, uncontrolled clinical study, of routine clinical practice, without drugs or medical devices
Study Design
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Sociodemographic data: [Patients will be followed over a period of 6 consecutive months]
Age
- Sociodemographic data: [Patients will be followed over a period of 6 consecutive months]
Sex
- Sociodemographic data: [Patients will be followed over a period of 6 consecutive months]
Educational level
- Sociodemographic data: [Patients will be followed over a period of 6 consecutive months]
Toxic habits
- Sociodemographic data: [Patients will be followed over a period of 6 consecutive months]
Medical history
- Sociodemographic data: [Patients will be followed over a period of 6 consecutive months]
Risk of sarcopenia and moderate to high malnutrition based on MUST and SARC-F screening test using R-MAPP.
- Subjective Global Assessment (SGA) [Patients will be followed over a period of 6 consecutive months]
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.
- Anthropometric data: [Patients will be followed over a period of 6 consecutive months]
Current body weight (measured or estimated)
- Anthropometric data: [Patients will be followed over a period of 6 consecutive months]
Usual weight
- Anthropometric data: [Patients will be followed over a period of 6 consecutive months]
Adjusted weight (adjusted weight in obese subjects, dry weight without oedema in malnourished subjects)
- Anthropometric data: [Patients will be followed over a period of 6 consecutive months]
Height (measured or estimated)
- Anthropometric data: [Patients will be followed over a period of 6 consecutive months]
BMI (body mass index)
- Anthropometric data: [Patients will be followed over a period of 6 consecutive months]
Arm circumference
- Bioelectrical impedance data (model (50 kHz): [Patients will be followed over a period of 6 consecutive months]
TBW (total body water, L),
- Bioelectrical impedance data (model (50 kHz): [Patients will be followed over a period of 6 consecutive months]
ECW (extracellular water, L),
- Bioelectrical impedance data (model (50 kHz): [Patients will be followed over a period of 6 consecutive months]
ICW (intracellular water, L),
- Bioelectrical impedance data (model (50 kHz): [Patients will be followed over a period of 6 consecutive months]
FFM (lean mass, kg),
- Bioelectrical impedance data (model (50 kHz): [Patients will be followed over a period of 6 consecutive months]
FM (fat mass, kg),
- Bioelectrical impedance data (model (50 kHz): [Patients will be followed over a period of 6 consecutive months]
BCM (body cell mass, kg),
- Bioelectrical impedance data (model (50 kHz): [Patients will be followed over a period of 6 consecutive months]
ASMM (appendicular skeletal muscle mass, kg),
- Bioelectrical impedance data (model (50 kHz): [Patients will be followed over a period of 6 consecutive months]
SMI (skeletal muscle mass index, kg),
- Bioelectrical impedance data (model (50 kHz): [Patients will be followed over a period of 6 consecutive months]
Percent hydration.
- Bioelectrical impedance data (model (50 kHz): [Patients will be followed over a period of 6 consecutive months]
% body fat
- Blood biochemistry data (at baseline visit, at 3 and 6 months): [Patients will be followed over a period of 6 consecutive months]
albumin
- Blood biochemistry data (at baseline visit, at 3 and 6 months): [Patients will be followed over a period of 6 consecutive months]
prealbumin
- Blood biochemistry data (at baseline visit, at 3 and 6 months): [Patients will be followed over a period of 6 consecutive months]
C-reactive protein
- Blood biochemistry data (at baseline visit, at 3 and 6 months): [Patients will be followed over a period of 6 consecutive months]
total cholesterol
- Blood biochemistry data (at baseline visit, at 3 and 6 months): [Patients will be followed over a period of 6 consecutive months]
lymphocytes
- Functional parameters: [Patients will be followed over a period of 6 consecutive months]
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.
- Functional parameters: [Patients will be followed over a period of 6 consecutive months]
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.
- Current patient status: [Patients will be followed over a period of 6 consecutive months]
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.
- Adherence. [Patients will be followed over a period of 6 consecutive months]
Attendance to study follow-up visits.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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Patient aged 18 to 85 years.
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Patient who agrees to participate in the study and signs the informed consent.
Exclusion Criteria:
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Hepatic impairment (AST/ALT 3 x upper limit of normal)
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Chronic kidney failure (GFR <45 mL/min)
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Patient with previous ICU stay during the study admission.
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Cancer patients on palliative treatment or ECOG (Eastern Cooperative Oncology Group) ≥
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Orthopaedic disease that does not allow adequate walking
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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.
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Patients with eating disorders
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Life expectancy of less than 6 months.
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Patients unable to adequately complete the clinical laboratory assessments required for the study protocol.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Servicio de Endocrinología y Nutrición. Complejo Hospitalario Universitario de Ferrol, A Coruña. | A Coruña | Spain | ||
| 2 | Hospital Universitario de Badajoz | Badajoz | Spain | ||
| 3 | Hospital Universitario Vall d´Hebron | Barcelona | Spain | ||
| 4 | Hospital Universitario de Basurto | Bilbao | Spain | ||
| 5 | Hospital Universitario Puerta del Mar | Cadiz | Spain | ||
| 6 | Hospital Universitario Reina Sofía | Córdoba | Spain | ||
| 7 | Hospital Universitario de Cabueñes | Gijón | Spain | ||
| 8 | Hospital Universitario Virgen de las Nieves | Granada | Spain | ||
| 9 | Hospital Universitario de Jaén | Jaén | Spain | ||
| 10 | Complejo Hospitalario Uni. Insular - Materno Infantil | Las Palmas De Gran Canaria | Spain | ||
| 11 | Hospital General Universitario Gregorio Marañón | Madrid | Spain | ||
| 12 | Hospital Universitario 12 de Octubre | Madrid | Spain | ||
| 13 | Hospital Universitario de La Princesa | Madrid | Spain | ||
| 14 | Hospital Universitario La Paz | Madrid | Spain | ||
| 15 | Clinical Management Unit of Endocrinology and Nutrition. Virgen de la Victoria Clinical Hospital, Málaga | Málaga | Spain | ||
| 16 | UGC Endocrinología y Nutrición. Hospital Regional Universitario, Málaga. | Málaga | Spain | ||
| 17 | Hospital Universitario de Navarra | Pamplona | Spain | ||
| 18 | Hospital Universitario de Canarias | Santa Cruz De Tenerife | Spain | ||
| 19 | Hospital Universitario Marqués de Valdecilla | Santander | Spain | ||
| 20 | Hospital Clínico Universitario de Santiago de Compostela | Santiago De Compostela | Spain | ||
| 21 | Hospital Universitario Virgen del Rocío | Sevilla | Spain | ||
| 22 | Hospital Universitario Virgen Macarena | Sevilla | Spain | ||
| 23 | Hospital Clínico Universitario de Valencia | Valencia | Spain | ||
| 24 | Hospital General Universitario de Valencia | Valencia | Spain | ||
| 25 | Servicio de Endocrinología y Nutrición. Hospital Clínico Universitario de Valladolid, Valladolid. | Valladolid | Spain |
Sponsors and Collaborators
- K Access Health Projects
- Abbott
Investigators
- Principal Investigator: José Manuel García Almeida, PhD, Hospital Clínico Virgen de la Victoria, Málaga (España)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ALM-DRECO-2021-01