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Completed

NCT Number: NCT02577211

Hypocaloric Enteral Nutrition in the Critically Ill Patient

The aim of this study is to compare two nutritional regimes in critically ill patients. Patients will be randomized to standard care (25 kcal per kg) or to hypocaloric nutrition (15 kcal per kg). Both regimes will recive 1,7 g/Kg/dia The main outcome will be the SOFA (sequential organ failure assessment) score. The hypothesis is that hypocaloric hyperproteic diet decreases the incidence of organic failure in these patients.

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Key information

Conditions

Critically Ill Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Universitario San Ignacio

Bogotá, Bogota D.C., 000000, Colombia

About this study

The research site will be the intensive care unit (ICU) of Hospital Universitario San Ignacio; eligible patients will >18 years of age with a presumed fasting period of at least 96 hours, with no contraindications for enteral nutrition. Patients with parenteral nutrition, pregnancy, diabetes, liver failure, renal failure, transplant protocol, or admitted from another hospital will be excluded. In all patients, the following information will be collected daily: enteral formula in ml, carbohydrate intake, insulin required (in IU), presence of hyper or hypoglicemia, presence of infections, among others.

The SOFA score will be assessed every two days until discharge from ICU.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • >18 years
  • Estimated fasting period of at least 96 hours
  • ICU patients

Exclusion criteria

  • Parenteral nutrition
  • Pregnancy
  • Diabetes
  • Liver failure
  • Transplantation or in transplant protocol
  • Previous nutrition support
  • Chronic Renal failure

Treatment and study plan

Hipocaloric enteral nutrition

Dietary Supplement

15 kcal/Kg of body weight

Other names: low caloric delivery

Normocaloric enteral nutrition

Dietary Supplement

25 kcal/kg of body weight

Primary outcomes

  1. Change in the intial SOFA (Sequential Organ Failure Assessment) score at 48 hours.

    Time frame: 48 hours after the onset of nutrition

    SOFA score evaluates six systems: respiratory, cardiovascular, coagulation, Central Nervous System, liver and renal. Each system gets a score from 0 (normal) to 4 (abnormal) and the sum of each score defines the final SOFA score, which 24 is the maximum score (high risk of morality) and 0 is the minimum score (low risk of mortality).

Secondary outcomes

  1. Units of insulin require in a day

    Time frame: Within the first 4 days after the onset of nutrition

    This is an indirect measure of glycemic control, and is reported as a daily average of the units of insuline require in the first 4 days since nutritional regimen starts.

  2. Number of days the patient requires mechanical ventilation.

    Time frame: Within the first 28 days after the onset of nutrition

    Measure daily

  3. Number of days in the intensive care unit

    Time frame: Within the first 28 days after the onset of nutrition

    Measure daily

  4. Mortality to 28 days

    Time frame: 28 days after the onset of nutrition

    We will interview each patient 28 days after the start of the study to assess the global mortality

Sponsors and collaborators

Lead sponsor

Lafrancol S.A.

Industry

Collaborators

  • Hospital Universitario San Ignacio
  • Pontificia Universidad Javeriana

Registry information

Official study title

Randomized Controlled Trial of Hypocaloric Hyperproteic Enteral Nutrition in the Critically Ill Patient

Acronym: hipoentnut

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 16, 2015
Registry last updated
Nov 10, 2015

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.

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