Nutrition DisordersNCT05433831
Application of Nutritional Ultrasound in the Diagnosis and Follow-up of Patients With Nutritional Risk: DRECO Study
An observational study of Nutrition Disorders and Malnutrition, run by K Access Health Projects at 25 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Nutrition Disorders, Malnutrition
- How many people
- 1,000 participants
- Where
- 25 sitesSpain
- Study dates
- 1 Jan 2022to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Spain25 sites, 25 recruiting
- Recruiting
Servicio de Endocrinología y Nutrición. Complejo Hospitalario Universitario de Ferrol, A Coruña.
A Coruña
Diego Bellido Guerrero, Ph, diegobellido@gmail.com
Diego Bellido Guerrero, Ph
- Recruiting
Hospital Universitario de Badajoz
Badajoz
Luis Miguel Luengo Pérez, Ph
- Recruiting
Hospital Universitario Vall d´Hebron
Barcelona
Rosa Burgos Peláez, Ph
- Recruiting
Hospital Universitario de Basurto
Bilbao
Natalia Covadonga Iglesias Hernández, Ph
- Recruiting
Hospital Universitario Puerta del Mar
Cadiz
Francisco Javier Vílchez López, Ph
- Recruiting
Hospital Universitario Reina Sofía
Córdoba
María José Molina Puerta, Ph
- Recruiting
Hospital Universitario de Cabueñes
Gijón
María Riestra Fernández, Ph
- Recruiting
Hospital Universitario Virgen de las Nieves
Granada
Juan Manuel Guardia Baena, Ph
- Recruiting
Hospital Universitario de Jaén
Jaén
María Josefa Martínez Ramírez, Ph
Inmaculada Prior Sánchez, Ph
- Recruiting
Complejo Hospitalario Uni. Insular - Materno Infantil
Las Palmas de Gran Canaria
Yaiza García Delgado, Ph
- Recruiting
Hospital General Universitario Gregorio Marañón
Madrid
Irene Bretón Lesmes, Ph
- Recruiting
Hospital Universitario 12 de Octubre
Madrid
María Maíz Jiménez, Ph
- Recruiting
Hospital Universitario de La Princesa
Madrid
Begoña Molina Baena, Ph
- Recruiting
Hospital Universitario La Paz
Madrid
Samara Palma Milla, Ph
- Recruiting
Clinical Management Unit of Endocrinology and Nutrition. Virgen de la Victoria Clinical Hospital, Málaga
Málaga
José Manuel García Almeida, +34 646314182, jgarcialameida@gmail.com
José Manuel García Almeida, Ph
- Recruiting
UGC Endocrinología y Nutrición. Hospital Regional Universitario, Málaga.
Málaga
Gabriel Olveira Fuster, Ph, gabrielolveiracasa@gmail.com
Gabriel Olveira Fuster, Ph
- Recruiting
Hospital Universitario de Navarra
Pamplona
Henry Rendón Barragán, Ph
- Recruiting
Hospital Universitario de Canarias
Santa Cruz de Tenerife
Tomás Martín Folgueras, Ph
- Recruiting
Hospital Universitario Marqués de Valdecilla
Santander
Coral Montalbán Carrasco, Ph
- Recruiting
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela
Miguel Ángel Martínez Olmos, Ph
- Recruiting
Hospital Universitario Virgen del Rocío
Seville
Pedro Pablo García Luna, Ph
- Recruiting
Hospital Universitario Virgen Macarena
Seville
Juana María Rabat Restrepo, Ph
- Recruiting
Hospital Clínico Universitario de Valencia
Valencia
Miguel Civera Andrés, Ph
- Recruiting
Hospital General Universitario de Valencia
Valencia
Carlos Sánchez Juan, Ph
- Recruiting
Servicio de Endocrinología y Nutrición. Hospital Clínico Universitario de Valladolid, Valladolid.
Valladolid
Daniel de Luís Román, Ph, dadluis@yahoo.es
Daniel de Luís Román, Ph
About this study
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
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.
Read more
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.
Read the detailed description
Prospective, multicenter, uncontrolled clinical study, of routine clinical practice, without drugs or medical devices
- Conditions
- Nutrition Disorders, Malnutrition
- Keywords
- Ultrasonography, Malnutrition, Clinical Nutrition, Disease Related Malnutrition
- Medical subject headings
- Nutrition Disorders, Malnutrition
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Patients will be followed over a period of 6 consecutive months
Secondary outcomes (32)
Sociodemographic data:
Age
Measured: Patients will be followed over a period of 6 consecutive months
Sociodemographic data:
Sex
Measured: Patients will be followed over a period of 6 consecutive months
Sociodemographic data:
Educational level
Measured: Patients will be followed over a period of 6 consecutive months
Sociodemographic data:
Toxic habits
Measured: Patients will be followed over a period of 6 consecutive months
Sociodemographic data:
Medical history
Measured: 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.
Measured: 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.
Measured: Patients will be followed over a period of 6 consecutive months
Anthropometric data:
Current body weight (measured or estimated)
Measured: Patients will be followed over a period of 6 consecutive months
Anthropometric data:
Usual weight
Measured: 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)
Measured: Patients will be followed over a period of 6 consecutive months
Anthropometric data:
Height (measured or estimated)
Measured: Patients will be followed over a period of 6 consecutive months
Anthropometric data:
BMI (body mass index)
Measured: Patients will be followed over a period of 6 consecutive months
Anthropometric data:
Arm circumference
Measured: Patients will be followed over a period of 6 consecutive months
Bioelectrical impedance data (model (50 kHz):
TBW (total body water, L),
Measured: Patients will be followed over a period of 6 consecutive months
Bioelectrical impedance data (model (50 kHz):
ECW (extracellular water, L),
Measured: Patients will be followed over a period of 6 consecutive months
Bioelectrical impedance data (model (50 kHz):
ICW (intracellular water, L),
Measured: Patients will be followed over a period of 6 consecutive months
Bioelectrical impedance data (model (50 kHz):
FFM (lean mass, kg),
Measured: Patients will be followed over a period of 6 consecutive months
Bioelectrical impedance data (model (50 kHz):
FM (fat mass, kg),
Measured: Patients will be followed over a period of 6 consecutive months
Bioelectrical impedance data (model (50 kHz):
BCM (body cell mass, kg),
Measured: Patients will be followed over a period of 6 consecutive months
Bioelectrical impedance data (model (50 kHz):
ASMM (appendicular skeletal muscle mass, kg),
Measured: Patients will be followed over a period of 6 consecutive months
Bioelectrical impedance data (model (50 kHz):
SMI (skeletal muscle mass index, kg),
Measured: Patients will be followed over a period of 6 consecutive months
Bioelectrical impedance data (model (50 kHz):
Percent hydration.
Measured: Patients will be followed over a period of 6 consecutive months
Bioelectrical impedance data (model (50 kHz):
% body fat
Measured: Patients will be followed over a period of 6 consecutive months
Blood biochemistry data (at baseline visit, at 3 and 6 months):
albumin
Measured: Patients will be followed over a period of 6 consecutive months
Blood biochemistry data (at baseline visit, at 3 and 6 months):
prealbumin
Measured: 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
Measured: Patients will be followed over a period of 6 consecutive months
Blood biochemistry data (at baseline visit, at 3 and 6 months):
total cholesterol
Measured: Patients will be followed over a period of 6 consecutive months
Blood biochemistry data (at baseline visit, at 3 and 6 months):
lymphocytes
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Patients will be followed over a period of 6 consecutive months
Adherence.
Attendance to study follow-up visits.
Measured: Patients will be followed over a period of 6 consecutive months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start1 Jan 2022
- Primary completionJun 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nutrition DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- K Access Health Projects
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Principal investigator, Dr. José Manuel García Almeida, Hospital Universitario Virgen de la Victoria
- Investigators
- José Manuel García Almeida, PhD, Principal investigator, Hospital Clínico Virgen de la Victoria, Málaga (España)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05433831
- Sponsor's protocol ID
- ALM-DRECO-2021-01
- Status last verified
- Jun 2022
- First submitted
- 16 Jun 2022
- Last updated
- 27 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38070895
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05433831
- Acronym / sponsor ID
- ALM-DRECO-2021-01
- Conditions
- Nutrition Disorders, Malnutrition
- Keywords
- Ultrasonography, Malnutrition, Clinical Nutrition, Disease Related Malnutrition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- K Access Health ProjectsUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 27 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Prospective, multicenter, uncontrolled clinical study, of routine clinical practice, without drugs or medical devices
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Nutritional ultrasound measurements: ultrasound with 4-10 cm linear probe.
Time frame: 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)
32 secondary outcomes
Sociodemographic data:
Time frame: Patients will be followed over a period of 6 consecutive months
Sociodemographic data:
Time frame: Patients will be followed over a period of 6 consecutive months
Sociodemographic data:
Time frame: Patients will be followed over a period of 6 consecutive months
Sociodemographic data:
Time frame: Patients will be followed over a period of 6 consecutive months
Sociodemographic data:
Time frame: Patients will be followed over a period of 6 consecutive months
Sociodemographic data:
Time frame: Patients will be followed over a period of 6 consecutive months
Subjective Global Assessment (SGA)
Time frame: Patients will be followed over a period of 6 consecutive months
Anthropometric data:
Time frame: Patients will be followed over a period of 6 consecutive months
Anthropometric data:
Time frame: Patients will be followed over a period of 6 consecutive months
Anthropometric data:
Time frame: Patients will be followed over a period of 6 consecutive months
Anthropometric data:
Time frame: Patients will be followed over a period of 6 consecutive months
Anthropometric data:
Time frame: Patients will be followed over a period of 6 consecutive months
Anthropometric data:
Time frame: Patients will be followed over a period of 6 consecutive months
Bioelectrical impedance data (model (50 kHz):
Time frame: Patients will be followed over a period of 6 consecutive months
Bioelectrical impedance data (model (50 kHz):
Time frame: Patients will be followed over a period of 6 consecutive months
Bioelectrical impedance data (model (50 kHz):
Time frame: Patients will be followed over a period of 6 consecutive months
Bioelectrical impedance data (model (50 kHz):
Time frame: Patients will be followed over a period of 6 consecutive months
Bioelectrical impedance data (model (50 kHz):
Time frame: Patients will be followed over a period of 6 consecutive months
Bioelectrical impedance data (model (50 kHz):
Time frame: Patients will be followed over a period of 6 consecutive months
Bioelectrical impedance data (model (50 kHz):
Time frame: Patients will be followed over a period of 6 consecutive months
Bioelectrical impedance data (model (50 kHz):
Time frame: Patients will be followed over a period of 6 consecutive months
Bioelectrical impedance data (model (50 kHz):
Time frame: Patients will be followed over a period of 6 consecutive months
Bioelectrical impedance data (model (50 kHz):
Time frame: Patients will be followed over a period of 6 consecutive months
Blood biochemistry data (at baseline visit, at 3 and 6 months):
Time frame: Patients will be followed over a period of 6 consecutive months
Blood biochemistry data (at baseline visit, at 3 and 6 months):
Time frame: Patients will be followed over a period of 6 consecutive months
Blood biochemistry data (at baseline visit, at 3 and 6 months):
Time frame: Patients will be followed over a period of 6 consecutive months
Blood biochemistry data (at baseline visit, at 3 and 6 months):
Time frame: Patients will be followed over a period of 6 consecutive months
Blood biochemistry data (at baseline visit, at 3 and 6 months):
Time frame: Patients will be followed over a period of 6 consecutive months
Functional parameters:
Time frame: Patients will be followed over a period of 6 consecutive months
Functional parameters:
Time frame: Patients will be followed over a period of 6 consecutive months
Current patient status:
Time frame: Patients will be followed over a period of 6 consecutive months
Adherence.
Time frame: Patients will be followed over a period of 6 consecutive months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
- Derived from this study: PubMed 38070895Garcia 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José Manuel García Almeida, PhD principal investigator
Hospital Clínico Virgen de la Victoria, Málaga (España)
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutrition Disorders and Malnutrition, run by K Access Health Projects at 25 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Núria Artigalàs Boixareu (610791607, nuriaartigalas@kaccesshealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutritional ultrasound measurements: ultrasound with 4-10 cm linear probe. (time frame: Patients will be followed over a period of 6 consecutive months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05433831, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2022.