Skip to main content
OpenTrials
Completed

NCT Number: NCT02583880

Screening Day Latin America

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Nutritional Status Caloric Deficit Hyperphagia Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fumeba, Bahía Blanca, Buenos Aires, Argentina

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Caloric deficit on the day before the Screening Day

    Time frame: On 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 outcomes

  1. Cumulative caloric deficit on days -1 to -5 before the screening day

    Time frame: Days -1 to -5

    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

  2. Nutritional status of the patient

    Time frame: The 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

  3. Current use of enteral and parenteral nutrition

    Time frame: At Screening Day

    The type and volume of administered enteral and parenteral nutrition will be recorded.

Sponsors and collaborators

Lead sponsor

Fresenius Kabi

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 22, 2015
Registry last updated
Dec 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.