Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,162

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Oct 2015

Shorter than P25 for all trials

Geographic Reach

8 countries

121 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

11 months study duration

Study Start

First participant enrolled

October 1, 2015

Completed

20 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2015

Completed

1 day until next milestone

First Posted

Study publicly available on registry

October 22, 2015

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed

Last Updated

December 20, 2016

Status Verified

September 1, 2016

Enrollment Period

11 months

First QC Date

October 21, 2015

Last Update Submit

December 19, 2016

Conditions

Nutritional Status Malnutrition Caloric Deficit

Keywords

nutritional statusmalnutritionenergy intakecaloric deficitICUhospitalenteral nutritionparenteral nutritionnutrition

Outcome Measures

Primary Outcomes (1)

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 Outcomes (3)

Cumulative caloric deficit on days -1 to -5 before the screening day
Days -1 to -5
Nutritional status of the patient
The Screening Day (Day 0) and the day of admission to the Intensive Care Unit (ICU)
Current use of enteral and parenteral nutrition
At Screening Day

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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

You may qualify if:

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.

You may not qualify if:

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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Fresenius Kabilead

Study Sites (121)

Fumeba

Bahía Blanca, Buenos Aires, 8000, Argentina

Location

Hospital Penna

Bahía Blanca, Buenos Aires, 8000, Argentina

Location

UAI

Buenos Aires, Buenos Aires, 1437, Argentina

Location

Hospital Británico

Caba, Buenos Aires, C1280AEB, Argentina

Location

Hospital Carrillo

Ciudadela, Buenos Aires, 1702, Argentina

Location

Hospital Fernandez

Caba, Buenos Aires F.D., C1425AGP, Argentina

Location

Sanatorio San Jose

Caba, Buenos Aires F.D., C1425DUH, Argentina

Location

Sanatorio Colegiales

Caba, Buenos Aires F.D., C1426AYQ, Argentina

Location

Hospital Raul Ferreyra

Córdoba, Córdoba Province, 5000, Argentina

Location

Sanatorio Allende

Córdoba, Córdoba Province, Argentina

Location

Hospital San Martín

La Plata, GBA, B1904CFU, Argentina

Location

Hospital El Cruce

San Juan Bautista, GBA, B1888AAE, Argentina

Location

Hospital Pablo Soria

San Salvador de Jujuy, Jujuy Province, 4600, Argentina

Location

Sanatorio Norte

San Salvador de Jujuy, Jujuy Province, 4600, Argentina

Location

CMIC

Neuquén, Neuquén Province, 8309, Argentina

Location

Hospital Eva Perón

Granadero Baigorria, Rosario, S2152EDD, Argentina

Location

Hospital Oñativia

Salta, Salta Province, 4.400, Argentina

Location

Hospital Cullen

Santa Fe, Santa Fe Province, S3000EOZ, Argentina

Location

H. Centro de Salud

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Location

Irmandade Nossa Senhora Das Merces

Montes Claros, Minas Gerais, 39400110, Brazil

Location

Hospital Das Clinicas Minas Gerais

Belo Horizonte, Brazil

Location

Hospital Felicio Rocho

Belo Horizonte, Brazil

Location

Hosp de Caridade São Vicente de Paulo

Jundiaí, Brazil

Location

Antonio Pedro (Huap)

Niterói, Brazil

Location

Quinta D'Or

Rio de Janeiro, Brazil

Location

Santa Casa de Misericórdia Da Bahia (Hosp St Izabel)

Salvador, Brazil

Location

Hospital Beneficência Portuguesa de Sp

São Paulo, Brazil

Location

Hospital Das Clinicas São Paulo

São Paulo, Brazil

Location

Hospital Sirio Libanes

São Paulo, Brazil

Location

Hospital Sta Marcelina de Itaquera

São Paulo, Brazil

Location

Instituto de Assistência Médica Ao Servidor Público Estadual - Iamspe

São Paulo, Brazil

Location

Hospital Metropolitano

Serra, Brazil

Location

Hospital Regional de Antofagasta

Antofagasta, Antofagasta, Chile

Location

Hospital Dr. Gustavo Fricke

Viña del Mar, Región de Valparaíso, Chile

Location

Hospital las Higueras

Concepción, Región del Biobío, Chile

Location

Salvador

Providencia, Santiago Metropolitan, Chile

Location

Clínica Dávila