Nutritional StatusNCT02583880
Screening Day Latin America
An observational study of Nutritional Status and Malnutrition, run by Fresenius Kabi at 121 sites in 8 countries.
Trial summary
This is a survey which will be performed on a specific day (the "Screening Day") in Latin American ICUs. In eligible patients who receive enteral or parenteral nutrition a retrospective calculation of the "caloric deficit" will be performed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nutritional Status, Malnutrition, Caloric Deficit
- How many people
- 1,162 participants
- Where
- 121 sitesin 8 countries
- Study dates
- Oct 2015to Sep 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill adult patients receiving enteral and/or parenteral nutrition, hospitalized in the Intensive Care Units (ICUs) of the participating hospitals on the Screening Day
Who may be able to join
- Patients will be included if the following criteria are fulfilled:
- Critically ill adult (≥18 years of age) patients, including critically ill major gastrointestinal surgery patients
- Patient is hospitalized in Intensive Care Unit (ICU) on the Screening Day
- Patients receiving enteral nutrition (EN; tube feeding only) and/or parenteral nutrition (PN) on the Screening Day and the day before the Screening Day
- Initiation of enteral nutrition (EN) and/or parenteral nutrition (PN) during ICU admission and at least one day before the Screening Day
- A critically ill patient is defined as a patient with at least one organ failure.
Who cannot join
- The following patients are excluded from the documentation:
- Critically ill burn patients
- Patients on the Intensive Care Unit (ICU) for surveillance without needing enteral nutrition (EN) and/or parenteral nutrition (PN)
Trial locations and contacts
121 sites in 8 countries.
121 sites in 8 countries
Chile22 sites
Hospital Regional de Antofagasta
Antofagasta, Antofagasta
Hospital las Higueras
Concepción, Biobio
Hospital Clínico Regional de Concepcion Grant Benavente
Concepción
Hospital Militar de Santiago
La Reina
Salvador
Providencia, Santiago Metropolitan
Clínica Bicentenario
Región Metropolitana
Hospital Clínico de la Universidad de Chile
Región Metropolitana
Clínica Dávila
Santiago, Santiago Metropolitan
Hospital Luis Tisne
Santiago, Santiago Metropolitan
Hospital San Jose
Santiago, Santiago Metropolitan
Hospital Universidad Católica
Santiago, Santiago Metropolitan
Indisa
Santiago, Santiago Metropolitan
San Borja
Santiago, Santiago Metropolitan
San Juan de Dios
Santiago, Santiago Metropolitan
Hospital Barros Luco-Trudeau
Santiago
Hospital Clínico La Florida
Santiago
Hospital Dipreca
Santiago
Mutual de Seguridad
Santiago
Hospital de Talca
Talca
Hospital Dr. Hernán Henríquez Aravena
Temuco
Hospital Dr. Gustavo Fricke
Viña del Mar, Valparaiso
Hospital Naval
Viña del Mar
Colombia22 sites
Clínica de la Costa
Barranquilla, Atlántico
Hospital del Cari
Barranquilla, Atlántico
Clínica Universitaria Colombia
Bogotá, Bogota D.C.
Hospital El Tunal
Bogotá, Bogota D.C.
Hospital San José Sociedad de Cirugía de Bogotá
Bogotá, Bogota D.C.
Hospital Universitario Clínica San Rafael
Bogotá, Bogota D.C.
Hospital Universitario Mayor MEDERI
Bogotá, Bogota D.C.
Clínica Rey David
Cali, Valle del Cauca Department
Fundación Valle de Lili
Cali
Clinica San José de Cúcuta
Cúcuta, Norte de Santander Department
Clínica Unipamplona
Cúcuta
Hospital Erasmo Meoz
Cúcuta
FOSCAL
Floridablanca, Santander Department
FOSUNAB
Floridablanca
SES Hospital de Caldas
Manizales
Clínica Medellín
Medellín
Fundación Hospitalaria San Vicente de Paul
Medellín
Hospital General de Medellín
Medellín
Promotora Clínica Las Américas
Medellín
Clínica Evaluamos
Montería, Departamento de Córdoba
IMAT
Montería, Departamento de Córdoba
Hospital San José de Popayán
Popayán, Cauca Department
Argentina19 sites
Fumeba
Bahía Blanca, Buenos Aires, 8000
Hospital Penna
Bahía Blanca, Buenos Aires, 8000
UAI
Buenos Aires, Buenos Aires, 1437
Hospital Británico
Caba, Buenos Aires, C1280AEB
Hospital Fernandez
Caba, Buenos Aires F.D., C1425AGP
Sanatorio San Jose
Caba, Buenos Aires F.D., C1425DUH
Sanatorio Colegiales
Caba, Buenos Aires F.D., C1426AYQ
Hospital Carrillo
Ciudadela, Buenos Aires, 1702
Hospital Raul Ferreyra
Córdoba, Córdoba Province, 5000
Sanatorio Allende
Córdoba, Córdoba Province
Hospital Eva Perón
Granadero Baigorria, Rosario, S2152EDD
Hospital San Martín
La Plata, GBA, B1904CFU
CMIC
Neuquén, Neuquén Province, 8309
Hospital Oñativia
Salta, Salta Province, 4.400
Hospital El Cruce
San Juan Bautista, GBA, B1888AAE
H. Centro de Salud
San Miguel de Tucumán, Tucumán Province, 4000
Hospital Pablo Soria
San Salvador de Jujuy, Jujuy Province, 4600
Sanatorio Norte
San Salvador de Jujuy, Jujuy Province, 4600
Hospital Cullen
Santa Fe, Santa Fe Province, S3000EOZ
Mexico15 sites
Central Universitario
Chihuahua City, Chihuahua, 31350
General de Cd. Juarez
Ciudad Juárez, Chihuahua, 32300
Hospital Civil de Guadalajara
Guadalajara, Jalisco, 44280
Hospital General Balbuena
Mexico City, Mexico City, 15970
Hospital General de México
Mexico City, Mexico City, 6726
Centro Médico Dalinde
Mexico City, Mexico City, 6760
Hospital Universitario
Monterrey, Nuevo Léon, 64460
Hospital General Pachuca
Pachuca, Hidalgo, 42070
Hospital de la Soledad
San Luis Potosí City, 78436
Hospital Metropolitano
San Nicolás de los Garza, Nuevo Léon, 66480
Hospital General de Tijuana
Tijuana, Estado de Baja California, 22320
Isem Centro Médico
Toluca, State of Mexico, 50010
Centro Médico Chiapas Nos Une "Dr. Jesús Gilberto Goméz Maza"
Tuxtla Gutiérrez, Chiapas, 29047
Hospital Regional de Veracruz
Veracruz, Veracruz, 95250
CEMEV
Xalapa, Veracruz, 91020
Peru15 sites
Centro Médico Naval
Callao
Hospital Alberto Leopoldo Barton Thompson
Callao
Hospital Alberto Sabogal Sologuren
Callao
Hospital Hipolito Unanue
El Agustino, Lima region
Hospital Regional Trujillo
La Libertad
Hospital Guillermo Kaelin de la Fuente
Lima, Provincia de Líma
Clinica Centenario
Lima
Clínica Adventista Good Hope
Lima
Hospital 2 de Mayo
Lima
Hospital Edgardo Rebagliati Martins
Lima
Hospital Guillermo Almenara Irigoyen
Lima
Hospital Luis Saenz de la Policia
Lima
Hospital Nacional Arzobispo Loayza
Lima
Hospital Santa Rosa
Lima
Hospital Víctor Lazarte de Red Asistencial La Libertad de EsSalud
Trujillo La Libertad
Ecuador14 sites
Hospital Carrasco Arteaga
Cuenca
Hospital Vicente Corral
Cuenca
Hospital Clínica Kennedy
Guayaquil
Hospital IESS Teodoro Maldonado Carbo
Guayaquil
Hospital Luis Vernaza
Guayaquil
Hospital Universitario
Guayaquil
Hospital de las Fuerzas Armadas
Quito, 170403
Hospital Carlos Andrade Marin
Quito
Hospital de la Policia
Quito
Hospital de los Valles
Quito
Hospital Eugenio Espejo
Quito
Hospital IESS San Francisco
Quito
Hospital Inglés
Quito
Hospital Metropolitano
Quito
Brazil13 sites
Hospital Das Clinicas Minas Gerais
Belo Horizonte
Hospital Felicio Rocho
Belo Horizonte
Hosp de Caridade São Vicente de Paulo
Jundiaí
Irmandade Nossa Senhora Das Merces
Montes Claros, Minas Gerais, 39400110
Antonio Pedro (Huap)
Niterói
Quinta D'Or
Rio de Janeiro
Santa Casa de Misericórdia Da Bahia (Hosp St Izabel)
Salvador
Hospital Beneficência Portuguesa de Sp
São Paulo
Hospital Das Clinicas São Paulo
São Paulo
Hospital Sirio Libanes
São Paulo
Hospital Sta Marcelina de Itaquera
São Paulo
Instituto de Assistência Médica Ao Servidor Público Estadual - Iamspe
São Paulo
Hospital Metropolitano
Serra
About this study
Official title: Screening Day Latin America to Assess Disease-related Malnutrition and Clinical Nutrition Practice in ICU Patients
This is a survey which will be performed on a specific day (the "Screening Day") in Latin American ICUs.
In eligible patients who receive enteral or parenteral nutrition a retrospective calculation of the "caloric deficit" will be performed. The caloric deficit is the difference between energy target of each patient and actually administered calories.
Read the detailed description
The Screening Day Latin America is a non-interventional, cross-sectional and retrospective study. The study focusses on patients receiving enteral (tube feeding, EN) and/or parenteral nutrition (PN).
All patients hospitalized on the defined Screening Day in participating ICUs will be checked for eligibility. In eligible patients the patient charts will be reviewed and the following parameters will be documented:
- Caloric deficit (daily target energy - actually administered energy via EN and PN). The caloric deficit will be calculated for 1 to up to 5 days before the Screening Day. The analysis will be done for each day and for the complete documentation period up to 5 days. Primary focus will be the caloric deficit on Day -1.
- Nutritional status of the patient based on information from the patient charts. For this, three tools will be applied independently: Subjective Global Assessment (SGA), NUTRIC Score, ESPEN diagnosis of malnutrition
The study will be performed in 8 Latin American countries.
Data will be recorded anonymously in an electronic case report form.
The study data of this explorative study will be analyzed using descriptive statistical methods.
- Conditions
- Nutritional Status, Malnutrition, Caloric Deficit
- Keywords
- nutritional status, malnutrition, energy intake, caloric deficit, ICU, hospital, enteral nutrition, parenteral nutrition, nutrition
- Medical subject headings
- Malnutrition, Hyperphagia
What is being measured
The primary outcome is the main question the study is designed to answer.
Caloric deficit on the day before the Screening Day
The caloric deficit on the day before the Screening Day will be derived by subtracting the provided calories from EN, PN and additional sources of caloric intake (e.g., dextrose-containing solutions, propofol emulsion) from the defined caloric target.
Equation: Caloric Deficit = Target Calories - Given Calories
If a caloric target is not provided/defined it will be assumed to be:
- 20 kcal/kg/day actual body weight for the first 6 days after ICU admission
- 25 kcal/kg/day actual body weight after day 6 of ICU admission period
Measured: On the day before the Screening Day (day -1)
Secondary outcomes (3)
Cumulative caloric deficit on days -1 to -5 before the screening day
The cumulative caloric deficit is the sum of the caloric deficit on day -1 + caloric deficit on Day -2 + caloric deficit on Day -3 + caloric deficit on Day -4 + caloric deficit on Day -5, depending on the number of days on the ICU
Measured: Days -1 to -5
Nutritional status of the patient
The nutritional status is assessed by using three different tools independently: The Subjective Global Assessment (SGA), the NUTRIC Score, and the ESPEN diagnosis of malnutrition
Measured: The Screening Day (Day 0) and the day of admission to the Intensive Care Unit (ICU)
Current use of enteral and parenteral nutrition
The type and volume of administered enteral and parenteral nutrition will be recorded.
Measured: At Screening Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional StatusStudies 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
- Time perspective
- Retrospective
- Enrolment
- 1,162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Kabi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John F Stover, MD, Study chair, Fresenius Kabi Deutschland GmbH, Borkenberg 14, 61440 Oberursel, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02583880
- Sponsor's protocol ID
- NScr-001-CNI
- Status last verified
- Sep 2016
- First submitted
- 21 Oct 2015
- Last updated
- 20 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening Day Latin America to Assess Disease-related Malnutrition and Clinical Nutrition Practice in ICU Patients
- ClinicalTrials.gov ID
- NCT02583880
- Acronym / sponsor ID
- NScr-001-CNI
- Conditions
- Nutritional Status, Malnutrition, Caloric Deficit
- Keywords
- nutritional status, malnutrition, energy intake, caloric deficit, ICU, hospital, enteral nutrition, parenteral nutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,162 participants (actual)
- Lead sponsor
- Fresenius KabiIndustry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 22 Oct 2015 (estimated)
- 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.
This is a survey which will be performed on a specific day (the "Screening Day") in Latin American ICUs.
In eligible patients who receive enteral or parenteral nutrition a retrospective calculation of the "caloric deficit" will be performed. The caloric deficit is the difference between energy target of each patient and actually administered calories.
Detailed description
The Screening Day Latin America is a non-interventional, cross-sectional and retrospective study. The study focusses on patients receiving enteral (tube feeding, EN) and/or parenteral nutrition (PN).
All patients hospitalized on the defined Screening Day in participating ICUs will be checked for eligibility. In eligible patients the patient charts will be reviewed and the following parameters will be documented:
- Caloric deficit (daily target energy - actually administered energy via EN and PN). The caloric deficit will be calculated for 1 to up to 5 days before the Screening Day. The analysis will be done for each day and for the complete documentation period up to 5 days. Primary focus will be the caloric deficit on Day -1.
- Nutritional status of the patient based on information from the patient charts. For this, three tools will be applied independently: Subjective Global Assessment (SGA), NUTRIC Score, ESPEN diagnosis of malnutrition
The study will be performed in 8 Latin American countries.
Data will be recorded anonymously in an electronic case report form.
The study data of this explorative study will be analyzed using descriptive statistical methods.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill adult patients receiving enteral and/or parenteral nutrition, hospitalized in the Intensive Care Units (ICUs) of the participating hospitals on the Screening Day
Key inclusion criteria (6 listed)
- Critically ill adult (≥18 years of age) patients, including critically ill major gastrointestinal surgery patients
- Patient is hospitalized in Intensive Care Unit (ICU) on the Screening Day
- Patients receiving enteral nutrition (EN; tube feeding only) and/or parenteral nutrition (PN) on the Screening Day and the day before the Screening Day
- Initiation of enteral nutrition (EN) and/or parenteral nutrition (PN) during ICU admission and at least one day before the Screening Day
- A critically ill patient is defined as a patient with at least one organ failure.
Key exclusion criteria (3 listed)
- Critically ill burn patients
- Patients on the Intensive Care Unit (ICU) for surveillance without needing enteral nutrition (EN) and/or parenteral nutrition (PN)
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
Caloric deficit on the day before the Screening Day
Time frame: On the day before the Screening Day (day -1)
The caloric deficit on the day before the Screening Day will be derived by subtracting the provided calories from EN, PN and additional sources of caloric intake (e.g., dextrose-containing solutions, propofol emulsion) from the defined caloric target. Equation: Caloric Deficit = Target Calories - Given Calories If a caloric target is not provided/defined it will be assumed to be: * 20 kcal/kg/day actual body weight for the first 6 days after ICU admission * 25 kcal/kg/day actual body weight after day 6 of ICU admission period
3 secondary outcomes
Cumulative caloric deficit on days -1 to -5 before the screening day
Time frame: Days -1 to -5
Nutritional status of the patient
Time frame: The Screening Day (Day 0) and the day of admission to the Intensive Care Unit (ICU)
Current use of enteral and parenteral nutrition
Time frame: At Screening Day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2016.
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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.
John F Stover, MD study chair
Fresenius Kabi Deutschland GmbH, Borkenberg 14, 61440 Oberursel, Germany
121 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutritional Status and Malnutrition, run by Fresenius Kabi at 121 sites in 8 countries.
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 6 inclusion and 3 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: finished, as of the sponsor's last update on 20 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 121 sites in Chile, Colombia, Argentina, Mexico, Peru and 3 more countries. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caloric deficit on the day before the Screening Day (time frame: On the day before the Screening Day (day -1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Dec 2016.