Screening Day Latin America

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.

Study Overview

• Status: Completed
• Conditions: Malnutrition; Nutritional Status; Caloric Deficit

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 Type: Observational
• Enrollment (Actual): 1162

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1437
    • UAI
  • Caba, Argentina, C1425DUH
    • Sanatorio San Jose
  • Caba, Argentina, C1425AGP
    • Hospital Fernandez
  • Caba, Argentina, C1426AYQ
    • Sanatorio Colegiales
  • Cordoba, Argentina, 5000
    • Hospital Raul Ferreyra
  • Neuquén, Argentina, 8309
    • CMIC
  • Salta, Argentina, 4.400
    • Hospital Oñativia
  • Santa Fe, Argentina, S3000EOZ
    • Hospital Cullen
  • Buenos Aires
    • Bahía Blanca, Buenos Aires, Argentina, 8000
      • Fumeba
    • Bahía Blanca, Buenos Aires, Argentina, 8000
      • Hospital Penna
    • Caba, Buenos Aires, Argentina, C1280AEB
      • Hospital Britanico
    • Ciudadela, Buenos Aires, Argentina, 1702
      • Hospital Carrillo
  • Córdoba
    • Cordoba, Córdoba, Argentina
      • Sanatorio Allende
  • GBA
    • Florencio Varela, GBA, Argentina, B1888AAE
      • Hospital El Cruce
    • La Plata, GBA, Argentina, B1904CFU
      • Hospital San Martin
  • Jujuy
    • San Salvador de Jujuy, Jujuy, Argentina, 4600
      • Hospital Pablo Soria
    • San Salvador de Jujuy, Jujuy, Argentina, 4600
      • Sanatorio Norte
  • Rosario
    • Granadero Baigorria, Rosario, Argentina, S2152EDD
      • Hospital Eva Perón
  • Tucumán
    • San Miguel de Tucumán, Tucumán, Argentina, 4000
      • H. Centro de Salud
• Brazil
  • Belo Horizonte, Brazil
    • Hospital Felício Rocho
  • Belo Horizonte, Brazil
    • Hospital das clinicas Minas Gerais
  • Jundiaí, Brazil
    • Hosp de Caridade São Vicente de Paulo
  • Niterói, Brazil
    • Antonio Pedro (Huap)
  • Rio de Janeiro, Brazil
    • Quinta D'Or
  • Salvador, Brazil
    • Santa Casa de Misericórdia Da Bahia (Hosp St Izabel)
  • Serra, Brazil
    • Hospital Metropolitano
  • São Paulo, Brazil
    • Hospital Sirio Libanes
  • São Paulo, Brazil
    • Hospital Beneficência Portuguesa de Sp
  • São Paulo, Brazil
    • Hospital das Clínicas São Paulo
  • São Paulo, Brazil
    • Hospital Sta Marcelina de Itaquera
  • São Paulo, Brazil
    • Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPE
  • Minas Gerais
    • Montes Claros, Minas Gerais, Brazil, 39400110
      • Irmandade Nossa Senhora Das Merces
• Chile
  • Concepción, Chile
    • Hospital Clínico Regional de Concepcion Grant Benavente
  • La Reina, Chile
    • Hospital Militar de Santiago
  • Región Metropolitana, Chile
    • Clínica Bicentenario
  • Región Metropolitana, Chile
    • Hospital Clinico de la Universidad de Chile
  • Santiago, Chile
    • Hospital Barros Luco-Trudeau
  • Santiago, Chile
    • Hospital Clinico La Florida
  • Santiago, Chile
    • Hospital Dipreca
  • Santiago, Chile
    • Hospital Universidad Catolica
  • Santiago, Chile
    • Mutual de Seguridad
  • Talca, Chile
    • Hospital de Talca
  • Temuco, Chile
    • Hospital Dr. Hernán Henríquez Aravena
  • Viña del Mar, Chile
    • Hospital Naval
  • Región Metropolitana
    • Providencia, Región Metropolitana, Chile
      • Salvador
    • Santiago, Región Metropolitana, Chile
      • Clínica Dávila
    • Santiago, Región Metropolitana, Chile
      • Hospital Luis Tisne
    • Santiago, Región Metropolitana, Chile
      • Hospital San José
    • Santiago, Región Metropolitana, Chile
      • INDISA
    • Santiago, Región Metropolitana, Chile
      • San Borja
    • Santiago, Región Metropolitana, Chile
      • San Juan de Dios
  • Región de Antofagasta
    • Antofagasta, Región de Antofagasta, Chile
      • Hospital Regional de Antofagasta
  • Región de Valparaíso
    • Viña del Mar, Región de Valparaíso, Chile
      • Hospital Dr. Gustavo Fricke
  • Región del Bío Bío
    • Concepción, Región del Bío Bío, Chile
      • Hospital Las Higueras
• Colombia
  • Bogotá, Colombia
    • Hospital Universitario Clinica San Rafael
  • Bogotá, Colombia
    • Clínica Universitaria Colombia
  • Bogotá, Colombia
    • Hospital El Tunal
  • Bogotá, Colombia
    • Hospital San José Sociedad de Cirugía de Bogotá
  • Bogotá, Colombia
    • Hospital Universitario Mayor Méderi
  • Cali, Colombia
    • Fundación Valle de Lili
  • Cúcuta, Colombia
    • Clínica Unipamplona
  • Cúcuta, Colombia
    • Hospital Erasmo Meoz
  • Floridablanca, Colombia
    • FOSUNAB
  • Manizales, Colombia
    • SES Hospital de Caldas
  • Medellín, Colombia
    • Fundación Hospitalaria San Vicente de Paul
  • Medellín, Colombia
    • Hospital General de Medellin
  • Medellín, Colombia
    • Clínica Medellín
  • Medellín, Colombia
    • Promotora Clínica Las Américas
  • Atlántico
    • Barranquilla, Atlántico, Colombia
      • Clinica de la Costa
    • Barranquilla, Atlántico, Colombia
      • Hospital del Cari
  • Cauca
    • Popayán, Cauca, Colombia
      • Hospital San Jose de Popayan
  • Córdoba
    • Montería, Córdoba, Colombia
      • Clínica Evaluamos
    • Montería, Córdoba, Colombia
      • IMAT
  • Norte de Santander
    • Cúcuta, Norte de Santander, Colombia
      • Clinica San José de Cúcuta
  • Santander
    • Floridablanca, Santander, Colombia
      • FOSCAL
  • Valle del Cauca
    • Cali, Valle del Cauca, Colombia
      • Clínica Rey David
• Ecuador
  • Cuenca, Ecuador
    • Hospital Carrasco Arteaga
  • Cuenca, Ecuador
    • Hospital Vicente Corral
  • Guayaquil, Ecuador
    • Hospital Luis Vernaza
  • Guayaquil, Ecuador
    • Hospital Clínica Kennedy
  • Guayaquil, Ecuador
    • Hospital IESS Teodoro Maldonado Carbo
  • Guayaquil, Ecuador
    • Hospital Universitário
  • Quito, Ecuador
    • Hospital Carlos Andrade Marin
  • Quito, Ecuador
    • Hospital de la Policia
  • Quito, Ecuador
    • Hospital de los Valles
  • Quito, Ecuador
    • Hospital Eugenio Espejo
  • Quito, Ecuador
    • Hospital Metropolitano
  • Quito, Ecuador, 170403
    • Hospital de las Fuerzas Armadas
  • Quito, Ecuador
    • Hospital IESS San Francisco
  • Quito, Ecuador
    • Hospital Inglés
• Mexico
  • Chihuahua, Mexico, 31350
    • Central Universitario
  • San Luis Potosi, Mexico, 78436
    • Hospital de la Soledad
  • Veracruz, Mexico, 95250
    • Hospital Regional de Veracruz
  • Baja California
    • Tijuana, Baja California, Mexico, 22320
      • Hospital General de Tijuana
  • Chiapas
    • Tuxtla Gutiérrez, Chiapas, Mexico, 29047
      • Centro Médico Chiapas Nos Une "Dr. Jesús Gilberto Goméz Maza"
  • Chihuahua
    • Ciudad Juárez, Chihuahua, Mexico, 32300
      • General de Cd. Juarez
  • Distrito Federal
    • Ciudad de México, Distrito Federal, Mexico, 15970
      • Hospital General Balbuena
    • Ciudad de México, Distrito Federal, Mexico, 6726
      • Hospital General de Mexico
    • Ciudad de México, Distrito Federal, Mexico, 6760
      • Centro Medico Dalinde
  • Estado de México
    • Toluca de Lerdo, Estado de México, Mexico, 50010
      • Isem Centro Médico
  • Hidalgo
    • Pachuca, Hidalgo, Mexico, 42070
      • Hospital General Pachuca
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44280
      • Hospital Civil de Guadalajara
  • Nuevo Léon
    • Monterrey, Nuevo Léon, Mexico, 64460
      • Hospital Universitário
    • San Nicolás de los Garza, Nuevo Léon, Mexico, 66480
      • Hospital Metropolitano
  • Veracruz
    • Xalapa, Veracruz, Mexico, 91020
      • CEMEV
• Panama
  • Ciudad de Panamá, Panama
    • Caja del Seguro Social
• Peru
  • Callao, Peru
    • Hospital Alberto Sabogal Sologuren
  • Callao, Peru
    • Centro Medico Naval
  • Callao, Peru
    • Hospital Alberto Leopoldo Barton Thompson
  • La Libertad, Peru
    • Hospital Regional Trujillo
  • Lima, Peru
    • Hospital Nacional Arzobispo Loayza
  • Lima, Peru
    • Hospital Guillermo Almenara Irigoyen
  • Lima, Peru
    • Hospital Edgardo Rebagliati Martins
  • Lima, Peru
    • Clinica Centenario
  • Lima, Peru
    • Clínica Adventista Good Hope
  • Lima, Peru
    • Hospital 2 de Mayo
  • Lima, Peru
    • Hospital Luis Saenz de la Policia
  • Lima, Peru
    • Hospital Santa Rosa
  • Trujillo La Libertad, Peru
    • Hospital Víctor Lazarte de Red Asistencial La Libertad de EsSalud
  • Lima
    • El Agustino, Lima, Peru
      • Hospital Hipolito Unanue
  • Provincia de Líma
    • Lima, Provincia de Líma, Peru
      • Hospital Guillermo Kaelin de la Fuente

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)
Current use of enteral and parenteral nutrition	The type and volume of administered enteral and parenteral nutrition will be recorded.	At Screening Day

Collaborators and Investigators

• Sponsor: Fresenius Kabi
• Investigators: Study Chair: John F Stover, MD, Fresenius Kabi Deutschland GmbH, Borkenberg 14, 61440 Oberursel, Germany

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: October 21, 2015
• First Submitted That Met QC Criteria: October 21, 2015
• First Posted (Estimate): October 22, 2015

Study Record Updates

• Last Update Posted (Estimate): December 20, 2016
• Last Update Submitted That Met QC Criteria: December 19, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: nutritional status; nutrition; energy intake; ICU; malnutrition; hospital; enteral nutrition; parenteral nutrition; caloric deficit
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: NScr-001-CNI