Phase 3
N=80
Hypocaloric Nutrition in Critically Ill Patients
Critically Ill
Bottom Line
View on ClinicalTrials.gov: NCT01531335 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcome: Primary: SOFA (Sequential Organ Failure Assessment) Score — 0.7; 1.7 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Hypocaloric hyperproteic nutrition (Dietary_supplement); Standard care (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Lafrancol S.A.
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY SOFA (Sequential Organ Failure Assessment) Score |
0.7; 1.7 | — |
| SECONDARY Insulin Requirements |
14; 10.4 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01531335). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.