Hypocaloric Nutrition in Critically Ill Patients
RuRaL
Effectiveness of Hypocaloric Nutrition Compared With Standard Care in Critically Ill Adults Patients, a Randomized Controlled Trial
1 other identifier
interventional
80
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Aug 2011
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 7, 2012
CompletedFirst Posted
Study publicly available on registry
February 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedResults Posted
Study results publicly available
December 11, 2015
CompletedDecember 11, 2015
November 1, 2015
1 year
February 7, 2012
December 16, 2013
November 7, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
SOFA (Sequential Organ Failure Assessment) Score
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).
48 hours since nutritional regime starts
Secondary Outcomes (1)
Insulin Requirements
Daily until day 21 or discharge from ICU
Study Arms (2)
Standard care
ACTIVE COMPARATORPatients will receive normal nutritional regime of around 25 kcal per kg.
Hypocaloric hyperproteic nutrition
EXPERIMENTAL15 kcal per kg of body weight and 1.7 grams of protein per kg
Interventions
15 kcal per kg of body weight and 1.7 grams of protein per kg.
Eligibility Criteria
You may qualify if:
- \>18 years
- estimated fasting period of at least 96 hours
You may not qualify if:
- parenteral nutrition
- pregnancy
- diabetes
- liver or renal failure
- transplantation
- admitted from another hospital
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lafrancol S.A.lead
- Hospital Universitario San Ignaciocollaborator
Study Sites (1)
Hospital Universitario San Ignacio
Bogotá, DC, 110311, Colombia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
No surgical patients included Wide variety of patients Caloric needs were not estimated with a gold standard
Results Point of Contact
- Title
- Dr Saul Rugeles
- Organization
- Pontificia Universidad Javeriana
Study Officials
- PRINCIPAL INVESTIGATOR
Saul Rugeles, MD
Pontificia Universidad Javeriana
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2012
First Posted
February 10, 2012
Study Start
August 1, 2011
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
December 11, 2015
Results First Posted
December 11, 2015
Record last verified: 2015-11