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NCT Number: NCT01531335

Hypocaloric Nutrition in Critically Ill Patients

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). 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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Universitario San Ignacio

Bogotá, DC, 110311, 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

Exclusion criteria

  • parenteral nutrition
  • pregnancy
  • diabetes
  • liver or renal failure
  • transplantation
  • admitted from another hospital

Treatment and study plan

Hypocaloric hyperproteic nutrition

Dietary Supplement

15 kcal per kg of body weight and 1.7 grams of protein per kg.

Other names: Hypocaloric hyperproteic

Standard care

Dietary Supplement

25 kcal per kg of body weight

Other names: Isocaloric

Primary outcomes

  1. SOFA (Sequential Organ Failure Assessment) Score

    Time frame: 48 hours since nutritional regime starts

    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. Insulin Requirements

    Time frame: Daily until day 21 or discharge from ICU

    This is an indirect measure of glycemic control, and is reported as a daily average.

Sponsors and collaborators

Lead sponsor

Lafrancol S.A.

Industry

Collaborators

  • Hospital Universitario San Ignacio

Registry information

Official study title

Effectiveness of Hypocaloric Nutrition Compared With Standard Care in Critically Ill Adults Patients, a Randomized Controlled Trial

Acronym: RuRaL

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 10, 2012
Registry last updated
Dec 11, 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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