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Clinical Trials
NCT02583880

Screening Day Latin America

Last Updated: 2016-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1162 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-09-30

Brief Summary

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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

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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.

Conditions

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Nutritional Status Malnutrition Caloric Deficit

Keywords

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nutritional status malnutrition energy intake caloric deficit ICU hospital enteral nutrition parenteral nutrition nutrition

Study Design

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Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John F Stover, MD

Role: STUDY_CHAIR

Fresenius Kabi Deutschland GmbH, Borkenberg 14, 61440 Oberursel, Germany

Locations

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Fumeba

Bahía Blanca, Buenos Aires, Argentina

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Hospital Penna

Bahía Blanca, Buenos Aires, Argentina

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UAI

Buenos Aires, Buenos Aires, Argentina

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Hospital Británico

Caba, Buenos Aires, Argentina

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Hospital Carrillo

Ciudadela, Buenos Aires, Argentina

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Hospital Fernandez

Caba, Buenos Aires F.D., Argentina

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Sanatorio San Jose

Caba, Buenos Aires F.D., Argentina

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Sanatorio Colegiales

Caba, Buenos Aires F.D., Argentina

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Hospital Raul Ferreyra

Córdoba, Córdoba Province, Argentina

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Sanatorio Allende

Córdoba, Córdoba Province, Argentina

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Hospital San Martín

La Plata, GBA, Argentina

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Hospital El Cruce

San Juan Bautista, GBA, Argentina

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Hospital Pablo Soria

San Salvador de Jujuy, Jujuy Province, Argentina

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Sanatorio Norte

San Salvador de Jujuy, Jujuy Province, Argentina

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CMIC

Neuquén, Neuquén Province, Argentina

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Hospital Eva Perón

Granadero Baigorria, Rosario, Argentina

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Hospital Oñativia

Salta, Salta Province, Argentina

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Hospital Cullen

Santa Fe, Santa Fe Province, Argentina

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H. Centro de Salud

San Miguel de Tucumán, Tucumán Province, Argentina

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Irmandade Nossa Senhora Das Merces

Montes Claros, Minas Gerais, Brazil

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Hospital Das Clinicas Minas Gerais

Belo Horizonte, , Brazil

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Hospital Felicio Rocho

Belo Horizonte, , Brazil

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Hosp de Caridade São Vicente de Paulo

Jundiaí, , Brazil

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Antonio Pedro (Huap)

Niterói, , Brazil

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Quinta D'Or

Rio de Janeiro, , Brazil

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Santa Casa de Misericórdia Da Bahia (Hosp St Izabel)

Salvador, , Brazil

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Hospital Beneficência Portuguesa de Sp

São Paulo, , Brazil

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Hospital Das Clinicas São Paulo

São Paulo, , Brazil

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Hospital Sirio Libanes

São Paulo, , Brazil

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Hospital Sta Marcelina de Itaquera

São Paulo, , Brazil

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Instituto de Assistência Médica Ao Servidor Público Estadual - Iamspe

São Paulo, , Brazil

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Hospital Metropolitano

Serra, , Brazil

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Hospital Regional de Antofagasta

Antofagasta, Antofagasta, Chile

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Hospital Dr. Gustavo Fricke

Viña del Mar, Región de Valparaíso, Chile

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Hospital las Higueras

Concepción, Región del Biobío, Chile

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