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Hypocaloric Enteral Nutrition in the Critically Ill Patient

NCT02577211 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2015-11-10

No results posted yet for this study

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). 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.

Conditions

  • Critically Ill

Interventions

DIETARY_SUPPLEMENT

Hipocaloric enteral nutrition

15 kcal/Kg of body weight

DIETARY_SUPPLEMENT

Normocaloric enteral nutrition

25 kcal/kg of body weight

Sponsors & Collaborators

  • Hospital Universitario San Ignacio

    collaborator OTHER

  • Pontificia Universidad Javeriana

    collaborator OTHER

  • Lafrancol S.A.

    lead INDUSTRY

Principal Investigators

  • Saul J Rugeles, MD · Hospital Universitario San Ignacio

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2015-07-31
Completion
2015-07-31

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 NCT02577211 on ClinicalTrials.gov