Screening Day Latin America

Malnutrition Clinical Trial

Official title:

Screening Day Latin America to Assess Disease-related Malnutrition and Clinical Nutrition Practice in ICU Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02583880
• Other study ID #: NScr-001-CNI
• 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

• Caloric Deficit
• Malnutrition
• Nutritional Status

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