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Screening Day Latin America

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02583880
Enrollment
1162
Registered
2015-10-22
Start date
2015-10-31
Completion date
2016-09-30
Last updated
2016-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caloric Deficit, Malnutrition, Nutritional Status

Keywords

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

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.

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.

Interventions

None listed

Sponsors

Fresenius Kabi
Lead SponsorINDUSTRY

Study design

Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Caloric deficit on the day before the Screening DayOn the day before the Screening Day (day -1)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

Secondary

MeasureTime frameDescription
Cumulative caloric deficit on days -1 to -5 before the screening dayDays -1 to -5The 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
Nutritional status of the patientThe Screening Day (Day 0) and the day of admission to the Intensive Care Unit (ICU)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
Current use of enteral and parenteral nutritionAt Screening DayThe type and volume of administered enteral and parenteral nutrition will be recorded.

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026