CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 80 enrolled
Drug / intervention
Hypocaloric hyperproteic nutrition +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01531335
NCT01531335Phase 3Completed
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Effectiveness of Hypocaloric Nutrition Compared With Standard Care in Critically Ill Adults Patients, a Randomized Controlled Trial

Lafrancol S.A.·interventional·Posted Feb 10, 2012·Updated Dec 11, 2015

In Brief

A Phase 3 clinical trial evaluating Hypocaloric hyperproteic nutrition and Standard care for Critically Ill. Completed, enrolled 80 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCritically Ill
CountriesColombia
CollaboratorsHospital Universitario San Ignacio

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 10, 2012
Enrollment StartAug 1, 2011
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 14.4 years ago

Interventions

Hypocaloric hyperproteic nutritiondietary

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

Standard caredietary

25 kcal per kg of body weight