Malnutrition Clinical Trial
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.
Status | Completed |
Enrollment | 1162 |
Est. completion date | September 2016 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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) |
Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
Argentina | Fumeba | Bahía Blanca | Buenos Aires |
Argentina | Hospital Penna | Bahía Blanca | Buenos Aires |
Argentina | UAI | Buenos Aires | |
Argentina | Hospital Británico | Caba | Buenos Aires |
Argentina | Hospital Fernandez | Caba | |
Argentina | Sanatorio Colegiales | Caba | |
Argentina | Sanatorio San Jose | Caba | |
Argentina | Hospital Carrillo | Ciudadela | Buenos Aires |
Argentina | Hospital Raul Ferreyra | Cordoba | |
Argentina | Sanatorio Allende | Cordoba | Córdoba |
Argentina | Hospital El Cruce | Florencio Varela | GBA |
Argentina | Hospital Eva Perón | Granadero Baigorria | Rosario |
Argentina | Hospital San Martín | La Plata | GBA |
Argentina | CMIC | Neuquén | |
Argentina | Hospital Oñativia | Salta | |
Argentina | H. Centro de Salud | San Miguel de Tucumán | Tucumán |
Argentina | Hospital Pablo Soria | San Salvador de Jujuy | Jujuy |
Argentina | Sanatorio Norte | San Salvador de Jujuy | Jujuy |
Argentina | Hospital Cullen | Santa Fe | |
Brazil | Hospital Das Clinicas Minas Gerais | Belo Horizonte | |
Brazil | Hospital Felicio Rocho | Belo Horizonte | |
Brazil | Hosp de Caridade São Vicente de Paulo | Jundiaí | |
Brazil | Irmandade Nossa Senhora Das Merces | Montes Claros | Minas Gerais |
Brazil | Antonio Pedro (Huap) | Niterói | |
Brazil | Quinta D'Or | Rio de Janeiro | |
Brazil | Santa Casa de Misericórdia Da Bahia (Hosp St Izabel) | Salvador | |
Brazil | Hospital Beneficência Portuguesa de Sp | São Paulo | |
Brazil | Hospital Das Clinicas São Paulo | São Paulo | |
Brazil | Hospital Sirio Libanes | São Paulo | |
Brazil | Hospital Sta Marcelina de Itaquera | São Paulo | |
Brazil | Instituto de Assistência Médica Ao Servidor Público Estadual - Iamspe | São Paulo | |
Brazil | Hospital Metropolitano | Serra | |
Chile | Hospital Regional de Antofagasta | Antofagasta | Región de Antofagasta |
Chile | Hospital Clínico Regional de Concepcion Grant Benavente | Concepción | |
Chile | Hospital las Higueras | Concepción | Región del Bío Bío |
Chile | Hospital Militar de Santiago | La Reina | |
Chile | Salvador | Providencia | Región Metropolitana |
Chile | Clínica Bicentenario | Región Metropolitana | |
Chile | Hospital Clínico de la Universidad de Chile | Región Metropolitana | |
Chile | Clínica Dávila | Santiago | Región Metropolitana |
Chile | Hospital Barros Luco-Trudeau | Santiago | |
Chile | Hospital Clínico La Florida | Santiago | |
Chile | Hospital Dipreca | Santiago | |
Chile | Hospital Luis Tisne | Santiago | Región Metropolitana |
Chile | Hospital San Jose | Santiago | Región Metropolitana |
Chile | Hospital Universidad Católica | Santiago | |
Chile | Indisa | Santiago | Región Metropolitana |
Chile | Mutual de Seguridad | Santiago | |
Chile | San Borja | Santiago | Región Metropolitana |
Chile | San Juan de Dios | Santiago | Región Metropolitana |
Chile | Hospital de Talca | Talca | |
Chile | Hospital Dr. Hernán Henríquez Aravena | Temuco | |
Chile | Hospital Dr. Gustavo Fricke | Viña del Mar | Región de Valparaíso |
Chile | Hospital Naval | Viña del Mar | |
Colombia | Clínica de la Costa | Barranquilla | Atlántico |
Colombia | Hospital del Cari | Barranquilla | Atlántico |
Colombia | Clínica Universitaria Colombia | Bogotá | |
Colombia | Hospital El Tunal | Bogotá | |
Colombia | Hospital San José Sociedad de Cirugía de Bogotá | Bogotá | |
Colombia | Hospital Universitario Clínica San Rafael | Bogotá | |
Colombia | Hospital Universitario Mayor MEDERI | Bogotá | |
Colombia | Clínica Rey David | Cali | Valle del Cauca |
Colombia | Fundación Valle de Lili | Cali | |
Colombia | Clinica San José de Cúcuta | Cúcuta | Norte de Santander |
Colombia | Clínica Unipamplona | Cúcuta | |
Colombia | Hospital Erasmo Meoz | Cúcuta | |
Colombia | FOSCAL | Floridablanca | Santander |
Colombia | FOSUNAB | Floridablanca | |
Colombia | SES Hospital de Caldas | Manizales | |
Colombia | Clínica Medellín | Medellín | |
Colombia | Fundación Hospitalaria San Vicente de Paul | Medellín | |
Colombia | Hospital General de Medellín | Medellín | |
Colombia | Promotora Clínica Las Américas | Medellín | |
Colombia | Clínica Evaluamos | Montería | Córdoba |
Colombia | IMAT | Montería | Córdoba |
Colombia | Hospital San José de Popayán | Popayán | Cauca |
Ecuador | Hospital Carrasco Arteaga | Cuenca | |
Ecuador | Hospital Vicente Corral | Cuenca | |
Ecuador | Hospital Clínica Kennedy | Guayaquil | |
Ecuador | Hospital IESS Teodoro Maldonado Carbo | Guayaquil | |
Ecuador | Hospital Luis Vernaza | Guayaquil | |
Ecuador | Hospital Universitario | Guayaquil | |
Ecuador | Hospital Carlos Andrade Marin | Quito | |
Ecuador | Hospital de la Policia | Quito | |
Ecuador | Hospital de las Fuerzas Armadas | Quito | |
Ecuador | Hospital de los Valles | Quito | |
Ecuador | Hospital Eugenio Espejo | Quito | |
Ecuador | Hospital IESS San Francisco | Quito | |
Ecuador | Hospital Inglés | Quito | |
Ecuador | Hospital Metropolitano | Quito | |
Mexico | Central Universitario | Chihuahua | |
Mexico | Centro Médico Dalinde | Ciudad de México | Distrito Federal |
Mexico | Hospital General Balbuena | Ciudad de México | Distrito Federal |
Mexico | Hospital General de México | Ciudad de México | Distrito Federal |
Mexico | General de Cd. Juarez | Ciudad Juárez | Chihuahua |
Mexico | Hospital Civil de Guadalajara | Guadalajara | Jalisco |
Mexico | Hospital Universitario | Monterrey | Nuevo Léon |
Mexico | Hospital General Pachuca | Pachuca | Hidalgo |
Mexico | Hospital de la Soledad | San Luis Potosi | |
Mexico | Hospital Metropolitano | San Nicolás de los Garza | Nuevo Léon |
Mexico | Hospital General de Tijuana | Tijuana | Baja California |
Mexico | Isem Centro Médico | Toluca de Lerdo | Estado de México |
Mexico | Centro Médico Chiapas Nos Une "Dr. Jesús Gilberto Goméz Maza" | Tuxtla Gutiérrez | Chiapas |
Mexico | Hospital Regional de Veracruz | Veracruz | |
Mexico | CEMEV | Xalapa | Veracruz |
Panama | Caja del Seguro Social | Ciudad de Panamá | |
Peru | Centro Médico Naval | Callao | |
Peru | Hospital Alberto Leopoldo Barton Thompson | Callao | |
Peru | Hospital Alberto Sabogal Sologuren | Callao | |
Peru | Hospital Hipolito Unanue | El Agustino | Lima |
Peru | Hospital Regional Trujillo | La Libertad | |
Peru | Clínica Adventista Good Hope | Lima | |
Peru | Clinica Centenario | Lima | |
Peru | Hospital 2 de Mayo | Lima | |
Peru | Hospital Edgardo Rebagliati Martins | Lima | |
Peru | Hospital Guillermo Almenara Irigoyen | Lima | |
Peru | Hospital Guillermo Kaelin de la Fuente | Lima | Provincia de Líma |
Peru | Hospital Luis Saenz de la Policia | Lima | |
Peru | Hospital Nacional Arzobispo Loayza | Lima | |
Peru | Hospital Santa Rosa | Lima | |
Peru | Hospital Víctor Lazarte de Red Asistencial La Libertad de EsSalud | Trujillo La Libertad |
Lead Sponsor | Collaborator |
---|---|
Fresenius Kabi |
Argentina, Brazil, Chile, Colombia, Ecuador, Mexico, Panama, Peru,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
On the day before the Screening Day (day -1) | No |
Secondary | 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 | Days -1 to -5 | No |
Secondary | 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 | The Screening Day (Day 0) and the day of admission to the Intensive Care Unit (ICU) | No |
Secondary | Current use of enteral and parenteral nutrition | The type and volume of administered enteral and parenteral nutrition will be recorded. | At Screening Day | No |
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