Clinical trial NCT02583880: Screening Day Latin America
Official title: Screening Day Latin America to Assess Disease-related Malnutrition and Clinical Nutrition Practice in ICU Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nutritional Status
Malnutrition
Caloric Deficit
Keywords: nutritional status
malnutrition
energy intake
caloric deficit
ICU
hospital
enteral nutrition
parenteral nutrition
nutrition
Lead sponsor: Fresenius Kabi
Sponsor class: INDUSTRY
First posted: 2015-10-22
Enrollment: 1162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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)

Primary outcomes:
measure: Caloric deficit on the day before the Screening Day
timeFrame: On the day before the Screening Day (day -1)
Secondary outcomes:
measure: Cumulative caloric deficit on days -1 to -5 before the screening day
timeFrame: Days -1 to -5
measure: Nutritional status of the patient
timeFrame: The Screening Day (Day 0) and the day of admission to the Intensive Care Unit (ICU)
measure: Current use of enteral and parenteral nutrition
timeFrame: At Screening Day
Other outcomes:
Locations:
city: Bahía Blanca
country: Argentina
facility: Fumeba
state: Buenos Aires
city: Bahía Blanca
country: Argentina
facility: Hospital Penna
state: Buenos Aires
city: Caba
country: Argentina
facility: Hospital Británico
state: Buenos Aires
city: Ciudadela
country: Argentina
facility: Hospital Carrillo
state: Buenos Aires
city: Cordoba
country: Argentina
facility: Sanatorio Allende
state: Córdoba
city: Florencio Varela
country: Argentina
facility: Hospital El Cruce
state: GBA
city: La Plata
country: Argentina
facility: Hospital San Martín
state: GBA
city: San Salvador de Jujuy
country: Argentina
facility: Hospital Pablo Soria
state: Jujuy
city: San Salvador de Jujuy
country: Argentina
facility: Sanatorio Norte
state: Jujuy
city: Granadero Baigorria
country: Argentina
facility: Hospital Eva Perón
state: Rosario
city: San Miguel de Tucumán
country: Argentina
facility: H. Centro de Salud
state: Tucumán
city: Buenos Aires
country: Argentina
facility: UAI
city: Caba
country: Argentina
facility: Hospital Fernandez
city: Caba
country: Argentina
facility: Sanatorio San Jose
city: Caba
country: Argentina
facility: Sanatorio Colegiales
city: Cordoba
country: Argentina
facility: Hospital Raul Ferreyra
city: Neuquén
country: Argentina
facility: CMIC
city: Salta
country: Argentina
facility: Hospital Oñativia
city: Santa Fe
country: Argentina
facility: Hospital Cullen
city: Montes Claros
country: Brazil
facility: Irmandade Nossa Senhora Das Merces
state: Minas Gerais
city: Belo Horizonte
country: Brazil
facility: Hospital Das Clinicas Minas Gerais
city: Belo Horizonte
country: Brazil
facility: Hospital Felicio Rocho
city: Jundiaí
country: Brazil
facility: Hosp de Caridade São Vicente de Paulo
city: Niterói
country: Brazil
facility: Antonio Pedro (Huap)
city: Rio de Janeiro
country: Brazil
facility: Quinta D'Or
city: Salvador
country: Brazil
facility: Santa Casa de Misericórdia Da Bahia (Hosp St Izabel)
city: Serra
country: Brazil
facility: Hospital Metropolitano
city: São Paulo
country: Brazil
facility: Hospital Beneficência Portuguesa de Sp
city: São Paulo
country: Brazil
facility: Hospital Das Clinicas São Paulo
city: São Paulo
country: Brazil
facility: Hospital Sirio Libanes
city: São Paulo
country: Brazil
facility: Hospital Sta Marcelina de Itaquera
city: São Paulo
country: Brazil
facility: Instituto de Assistência Médica Ao Servidor Público Estadual - Iamspe
city: Antofagasta
country: Chile
facility: Hospital Regional de Antofagasta
state: Región de Antofagasta
city: Viña del Mar
country: Chile
facility: Hospital Dr. Gustavo Fricke
state: Región de Valparaíso
city: Concepción
country: Chile
facility: Hospital las Higueras
state: Región del Bío Bío
city: Providencia
country: Chile
facility: Salvador
state: Región Metropolitana
city: Santiago
country: Chile
facility: Clínica Dávila
state: Región Metropolitana
city: Santiago
country: Chile
facility: Hospital Luis Tisne
state: Región Metropolitana
city: Santiago
country: Chile
facility: Hospital San Jose
state: Región Metropolitana
city: Santiago
country: Chile
facility: Indisa
state: Región Metropolitana
city: Santiago
country: Chile
facility: San Borja
state: Región Metropolitana
city: Santiago
country: Chile
facility: San Juan de Dios
state: Región Metropolitana
city: Concepción
country: Chile
facility: Hospital Clínico Regional de Concepcion Grant Benavente
city: La Reina
country: Chile
facility: Hospital Militar de Santiago
city: Región Metropolitana
country: Chile
facility: Clínica Bicentenario
city: Región Metropolitana
country: Chile
facility: Hospital Clínico de la Universidad de Chile
city: Santiago
country: Chile
facility: Hospital Barros Luco-Trudeau
city: Santiago
country: Chile
facility: Hospital Clínico La Florida
city: Santiago
country: Chile
facility: Hospital Dipreca
city: Santiago
country: Chile
facility: Hospital Universidad Católica
city: Santiago
country: Chile
facility: Mutual de Seguridad
city: Talca
country: Chile
facility: Hospital de Talca
city: Temuco
country: Chile
facility: Hospital Dr. Hernán Henríquez Aravena
city: Viña del Mar
country: Chile
facility: Hospital Naval
city: Barranquilla
country: Colombia
facility: Clínica de la Costa
state: Atlántico
city: Barranquilla
country: Colombia
facility: Hospital del Cari
state: Atlántico
city: Popayán
country: Colombia
facility: Hospital San José de Popayán
state: Cauca
city: Montería
country: Colombia
facility: Clínica Evaluamos
state: Córdoba
city: Montería
country: Colombia
facility: IMAT
state: Córdoba
city: Cúcuta
country: Colombia
facility: Clinica San José de Cúcuta
state: Norte de Santander
city: Floridablanca
country: Colombia
facility: FOSCAL
state: Santander
city: Cali
country: Colombia
facility: Clínica Rey David
state: Valle del Cauca
city: Bogotá
country: Colombia
facility: Clínica Universitaria Colombia
city: Bogotá
country: Colombia
facility: Hospital El Tunal
city: Bogotá
country: Colombia
facility: Hospital San José Sociedad de Cirugía de Bogotá
city: Bogotá
country: Colombia
facility: Hospital Universitario Clínica San Rafael
city: Bogotá
country: Colombia
facility: Hospital Universitario Mayor MEDERI
city: Cali
country: Colombia
facility: Fundación Valle de Lili
city: Cúcuta
country: Colombia
facility: Clínica Unipamplona
city: Cúcuta
country: Colombia
facility: Hospital Erasmo Meoz
city: Floridablanca
country: Colombia
facility: FOSUNAB
city: Manizales
country: Colombia
facility: SES Hospital de Caldas
city: Medellín
country: Colombia
facility: Clínica Medellín
city: Medellín
country: Colombia
facility: Fundación Hospitalaria San Vicente de Paul
city: Medellín
country: Colombia
facility: Hospital General de Medellín
city: Medellín
country: Colombia
facility: Promotora Clínica Las Américas
city: Cuenca
country: Ecuador
facility: Hospital Carrasco Arteaga
city: Cuenca
country: Ecuador
facility: Hospital Vicente Corral
city: Guayaquil
country: Ecuador
facility: Hospital Clínica Kennedy
city: Guayaquil
country: Ecuador
facility: Hospital IESS Teodoro Maldonado Carbo
city: Guayaquil
country: Ecuador
facility: Hospital Luis Vernaza
city: Guayaquil
country: Ecuador
facility: Hospital Universitario
city: Quito
country: Ecuador
facility: Hospital de las Fuerzas Armadas
city: Quito
country: Ecuador
facility: Hospital Carlos Andrade Marin
city: Quito
country: Ecuador
facility: Hospital de la Policia
city: Quito
country: Ecuador
facility: Hospital de los Valles
city: Quito
country: Ecuador
facility: Hospital Eugenio Espejo
city: Quito
country: Ecuador
facility: Hospital IESS San Francisco
city: Quito
country: Ecuador
facility: Hospital Inglés
city: Quito
country: Ecuador
facility: Hospital Metropolitano
city: Tijuana
country: Mexico
facility: Hospital General de Tijuana
state: Baja California
city: Tuxtla Gutiérrez
country: Mexico
facility: Centro Médico Chiapas Nos Une "Dr. Jesús Gilberto Goméz Maza"
state: Chiapas
city: Ciudad Juárez
country: Mexico
facility: General de Cd. Juarez
state: Chihuahua
city: Ciudad de México
country: Mexico
facility: Hospital General Balbuena
state: Distrito Federal
city: Ciudad de México
country: Mexico
facility: Hospital General de México
state: Distrito Federal
city: Ciudad de México
country: Mexico
facility: Centro Médico Dalinde
state: Distrito Federal
city: Toluca de Lerdo
country: Mexico
facility: Isem Centro Médico
state: Estado de México
city: Pachuca
country: Mexico
facility: Hospital General Pachuca
state: Hidalgo
city: Guadalajara
country: Mexico
facility: Hospital Civil de Guadalajara
state: Jalisco
city: Monterrey
country: Mexico
facility: Hospital Universitario
state: Nuevo Léon
city: San Nicolás de los Garza
country: Mexico
facility: Hospital Metropolitano
state: Nuevo Léon
city: Xalapa
country: Mexico
facility: CEMEV
state: Veracruz
city: Chihuahua
country: Mexico
facility: Central Universitario
city: San Luis Potosi
country: Mexico
facility: Hospital de la Soledad
city: Veracruz
country: Mexico
facility: Hospital Regional de Veracruz
city: Ciudad de Panamá
country: Panama
facility: Caja del Seguro Social
city: El Agustino
country: Peru
facility: Hospital Hipolito Unanue
state: Lima
city: Lima
country: Peru
facility: Hospital Guillermo Kaelin de la Fuente
state: Provincia de Líma
city: Callao
country: Peru
facility: Centro Médico Naval
city: Callao
country: Peru
facility: Hospital Alberto Leopoldo Barton Thompson
city: Callao
country: Peru
facility: Hospital Alberto Sabogal Sologuren
city: La Libertad
country: Peru
facility: Hospital Regional Trujillo
city: Lima
country: Peru
facility: Clinica Centenario
city: Lima
country: Peru
facility: Clínica Adventista Good Hope
city: Lima
country: Peru
facility: Hospital 2 de Mayo
city: Lima
country: Peru
facility: Hospital Edgardo Rebagliati Martins
city: Lima
country: Peru
facility: Hospital Guillermo Almenara Irigoyen
city: Lima
country: Peru
facility: Hospital Luis Saenz de la Policia
city: Lima
country: Peru
facility: Hospital Nacional Arzobispo Loayza
city: Lima
country: Peru
facility: Hospital Santa Rosa
city: Trujillo La Libertad
country: Peru
facility: Hospital Víctor Lazarte de Red Asistencial La Libertad de EsSalud
Study officials:
affiliation: Fresenius Kabi Deutschland GmbH, Borkenberg 14, 61440 Oberursel, Germany
name: John F Stover, MD
role: STUDY_CHAIR
References: