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Hypocaloric Nutrition in Critically Ill Patients

NCT01531335 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2015-12-11

Study results available
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Summary

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.

Conditions

  • Critically Ill

Interventions

DIETARY_SUPPLEMENT

Hypocaloric hyperproteic nutrition

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

DIETARY_SUPPLEMENT

Standard care

25 kcal per kg of body weight

Sponsors & Collaborators

  • Hospital Universitario San Ignacio

    collaborator OTHER

  • Lafrancol S.A.

    lead INDUSTRY

Principal Investigators

  • Saul Rugeles, MD · Pontificia Universidad Javeriana

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • Colombia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01531335 on ClinicalTrials.gov