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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02583880
Other study ID # NScr-001-CNI
Secondary ID
Status Completed
Phase N/A
First received October 21, 2015
Last updated December 19, 2016
Start date October 2015
Est. completion date September 2016

Study information

Verified date September 2016
Source Fresenius Kabi
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in ResearchChile: Servicio de Salud Metropolitano OrienteEcuador: Public Health MinistryMexico: Secretaría de Salud del Distrito Federal
Study type Observational

Clinical 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. The caloric deficit is the difference between energy target of each patient and actually administered calories.


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 information / eligibility

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)

Study Design

Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Fresenius Kabi

Countries where clinical trial is conducted

Argentina,  Brazil,  Chile,  Colombia,  Ecuador,  Mexico,  Panama,  Peru, 

Outcome

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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