Screening Day Latin America
- Conditions
- Nutritional StatusMalnutritionCaloric Deficit
- Registration Number
- NCT02583880
- Lead Sponsor
- Fresenius Kabi
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1162
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.
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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Caloric deficit on the day before the Screening Day 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
- Secondary Outcome Measures
Name Time Method Cumulative caloric deficit on days -1 to -5 before the screening day Days -1 to -5 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
Nutritional status of the patient The Screening Day (Day 0) and the day of admission to the Intensive Care Unit (ICU) 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
Current use of enteral and parenteral nutrition At Screening Day The type and volume of administered enteral and parenteral nutrition will be recorded.
Trial Locations
- Locations (118)
Sanatorio Norte
🇦🇷San Salvador de Jujuy, Jujuy, Argentina
Hospital Eva Perón
🇦🇷Granadero Baigorria, Rosario, Argentina
Hospital Británico
🇦🇷Caba, Buenos Aires, Argentina
Hospital El Cruce
🇦🇷Florencio Varela, GBA, Argentina
UAI
🇦🇷Buenos Aires, Argentina
Hospital Fernandez
🇦🇷Caba, Argentina
CMIC
🇦🇷Neuquén, Argentina
Hospital Felicio Rocho
🇧🇷Belo Horizonte, Brazil
Antonio Pedro (Huap)
🇧🇷Niterói, Brazil
Sanatorio San Jose
🇦🇷Caba, Argentina
Clínica Bicentenario
🇨🇱Región Metropolitana, Chile
Hospital Cullen
🇦🇷Santa Fe, Argentina
Quinta D'Or
🇧🇷Rio de Janeiro, Brazil
Hospital Sirio Libanes
🇧🇷São Paulo, Brazil
Hospital Das Clinicas Minas Gerais
🇧🇷Belo Horizonte, Brazil
Hospital Carrillo
🇦🇷Ciudadela, Buenos Aires, Argentina
Sanatorio Allende
🇦🇷Cordoba, Córdoba, Argentina
Hospital Dipreca
🇨🇱Santiago, Chile
Hosp de Caridade São Vicente de Paulo
🇧🇷Jundiaí, Brazil
Hospital San Martín
🇦🇷La Plata, GBA, Argentina
Sanatorio Colegiales
🇦🇷Caba, Argentina
Irmandade Nossa Senhora Das Merces
🇧🇷Montes Claros, Minas Gerais, Brazil
Hospital Naval
🇨🇱Viña del Mar, Chile
SES Hospital de Caldas
🇨🇴Manizales, Colombia
Hospital Carlos Andrade Marin
🇪🇨Quito, Ecuador
Hospital General de México
🇲🇽Ciudad de México, Distrito Federal, Mexico
Fumeba
🇦🇷Bahía Blanca, Buenos Aires, Argentina
Hospital Penna
🇦🇷Bahía Blanca, Buenos Aires, Argentina
Hospital Luis Vernaza
🇪🇨Guayaquil, Ecuador
Hospital IESS San Francisco
🇪🇨Quito, Ecuador
Hospital General Balbuena
🇲🇽Ciudad de México, Distrito Federal, Mexico
Hospital Guillermo Almenara Irigoyen
🇵🇪Lima, Peru
Isem Centro Médico
🇲🇽Toluca de Lerdo, Estado de México, Mexico
Hospital Dr. Gustavo Fricke
🇨🇱Viña del Mar, Región de Valparaíso, Chile
Hospital Pablo Soria
🇦🇷San Salvador de Jujuy, Jujuy, Argentina
H. Centro de Salud
🇦🇷San Miguel de Tucumán, Tucumán, Argentina
Hospital San Jose
🇨🇱Santiago, Región Metropolitana, Chile
Hospital Barros Luco-Trudeau
🇨🇱Santiago, Chile
CEMEV
🇲🇽Xalapa, Veracruz, Mexico
Hospital Clínico de la Universidad de Chile
🇨🇱Región Metropolitana, Chile
Hospital Universitario Clínica San Rafael
🇨🇴Bogotá, Colombia
Hospital General de Medellín
🇨🇴Medellín, Colombia
Hospital Vicente Corral
🇪🇨Cuenca, Ecuador
Hospital IESS Teodoro Maldonado Carbo
🇪🇨Guayaquil, Ecuador
General de Cd. Juarez
🇲🇽Ciudad Juárez, Chihuahua, Mexico
IMAT
🇨🇴Montería, Córdoba, Colombia
FOSCAL
🇨🇴Floridablanca, Santander, Colombia
Hospital Metropolitano
🇲🇽San Nicolás de los Garza, Nuevo Léon, Mexico
Hospital Luis Tisne
🇨🇱Santiago, Región Metropolitana, Chile
Hospital Regional de Antofagasta
🇨🇱Antofagasta, Región de Antofagasta, Chile
Salvador
🇨🇱Providencia, Región Metropolitana, Chile
Indisa
🇨🇱Santiago, Región Metropolitana, Chile
Hospital Militar de Santiago
🇨🇱La Reina, Chile
Hospital de Talca
🇨🇱Talca, Chile
Hospital Erasmo Meoz
🇨🇴Cúcuta, Colombia
Clínica Medellín
🇨🇴Medellín, Colombia
Hospital Clínica Kennedy
🇪🇨Guayaquil, Ecuador
Hospital Alberto Leopoldo Barton Thompson
🇵🇪Callao, Peru
Hospital Alberto Sabogal Sologuren
🇵🇪Callao, Peru
Hospital 2 de Mayo
🇵🇪Lima, Peru
Hospital Luis Saenz de la Policia
🇵🇪Lima, Peru
Hospital San José de Popayán
🇨🇴Popayán, Cauca, Colombia
Clínica Rey David
🇨🇴Cali, Valle del Cauca, Colombia
Hospital las Higueras
🇨🇱Concepción, Región del Bío Bío, Chile
Clínica Dávila
🇨🇱Santiago, Región Metropolitana, Chile
San Borja
🇨🇱Santiago, Región Metropolitana, Chile
Hospital Clínico Regional de Concepcion Grant Benavente
🇨🇱Concepción, Chile
Hospital Dr. Hernán Henríquez Aravena
🇨🇱Temuco, Chile
Clínica Unipamplona
🇨🇴Cúcuta, Colombia
FOSUNAB
🇨🇴Floridablanca, Colombia
Fundación Hospitalaria San Vicente de Paul
🇨🇴Medellín, Colombia
Hospital Carrasco Arteaga
🇪🇨Cuenca, Ecuador
Hospital de las Fuerzas Armadas
🇪🇨Quito, Ecuador
Centro Médico Chiapas Nos Une "Dr. Jesús Gilberto Goméz Maza"
🇲🇽Tuxtla Gutiérrez, Chiapas, Mexico
Hospital de la Soledad
🇲🇽San Luis Potosi, Mexico
Hospital Víctor Lazarte de Red Asistencial La Libertad de EsSalud
🇵🇪Trujillo La Libertad, Peru
Hospital del Cari
🇨🇴Barranquilla, Atlántico, Colombia
San Juan de Dios
🇨🇱Santiago, Región Metropolitana, Chile
Hospital Universidad Católica
🇨🇱Santiago, Chile
Clínica Universitaria Colombia
🇨🇴Bogotá, Colombia
Hospital El Tunal
🇨🇴Bogotá, Colombia
Hospital Universitario
🇲🇽Monterrey, Nuevo Léon, Mexico
Hospital de la Policia
🇪🇨Quito, Ecuador
Hospital de los Valles
🇪🇨Quito, Ecuador
Hospital Eugenio Espejo
🇪🇨Quito, Ecuador
Hospital Inglés
🇪🇨Quito, Ecuador
Hospital Regional de Veracruz
🇲🇽Veracruz, Mexico
Clínica de la Costa
🇨🇴Barranquilla, Atlántico, Colombia
Clínica Evaluamos
🇨🇴Montería, Córdoba, Colombia
Hospital Clínico La Florida
🇨🇱Santiago, Chile
Mutual de Seguridad
🇨🇱Santiago, Chile
Hospital San José Sociedad de Cirugía de Bogotá
🇨🇴Bogotá, Colombia
Hospital Universitario Mayor MEDERI
🇨🇴Bogotá, Colombia
Fundación Valle de Lili
🇨🇴Cali, Colombia
Clinica San José de Cúcuta
🇨🇴Cúcuta, Norte de Santander, Colombia
Promotora Clínica Las Américas
🇨🇴Medellín, Colombia
Hospital General Pachuca
🇲🇽Pachuca, Hidalgo, Mexico
Central Universitario
🇲🇽Chihuahua, Mexico
Hospital Guillermo Kaelin de la Fuente
🇵🇪Lima, Provincia de Líma, Peru
Clinica Centenario
🇵🇪Lima, Peru
Hospital General de Tijuana
🇲🇽Tijuana, Baja California, Mexico
Centro Médico Dalinde
🇲🇽Ciudad de México, Distrito Federal, Mexico
Caja del Seguro Social
🇵🇦Ciudad de Panamá, Panama
Hospital Hipolito Unanue
🇵🇪El Agustino, Lima, Peru
Centro Médico Naval
🇵🇪Callao, Peru
Hospital Regional Trujillo
🇵🇪La Libertad, Peru
Hospital Santa Rosa
🇵🇪Lima, Peru
Clínica Adventista Good Hope
🇵🇪Lima, Peru
Hospital Edgardo Rebagliati Martins
🇵🇪Lima, Peru
Hospital Nacional Arzobispo Loayza
🇵🇪Lima, Peru
Hospital Beneficência Portuguesa de Sp
🇧🇷São Paulo, Brazil
Hospital Das Clinicas São Paulo
🇧🇷São Paulo, Brazil
Hospital Sta Marcelina de Itaquera
🇧🇷São Paulo, Brazil
Instituto de Assistência Médica Ao Servidor Público Estadual - Iamspe
🇧🇷São Paulo, Brazil
Hospital Raul Ferreyra
🇦🇷Cordoba, Argentina
Hospital Oñativia
🇦🇷Salta, Argentina
Santa Casa de Misericórdia Da Bahia (Hosp St Izabel)
🇧🇷Salvador, Brazil
Hospital Civil de Guadalajara
🇲🇽Guadalajara, Jalisco, Mexico