Critically IllPhase 3RuRaLNCT01531335
Hypocaloric Nutrition in Critically Ill Patients
A Phase 3 study testing Hypocaloric hyperproteic nutrition in people with Critically Ill, run by Lafrancol S.A. at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill
- What is being tested?
- Hypocaloric hyperproteic nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteColombia
- Study dates
- Aug 2011to Aug 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years
- estimated fasting period of at least 96 hours
Who cannot join
- parenteral nutrition
- pregnancy
- diabetes
- liver or renal failure
- transplantation
- admitted from another hospital
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Hypocaloric Nutrition Compared With Standard Care in Critically Ill Adults Patients, a Randomized Controlled Trial
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.
Read the detailed description
The research site will be the intensive care unit (ICU) of Hospital Universitario San Ignacio; eligible patients will >18 years of age with a presumed fasting period of at least 96 hours, with no contraindications for enteral nutrition. Patients with parenteral nutrition, pregnancy, diabetes, liver failure, renal failure, transplant protocol, or admitted from another hospital will be excluded. In all patients, the following information will be collected daily: enteral formula in ml, carbohydrate intake, insulin required (in IU), presence of hyper or hypoglicemia, presence of infections, among others.
The SOFA score will be assessed every two days until discharge from ICU.
- Conditions
- Critically Ill
- Being tested
- Hypocaloric hyperproteic nutrition, Standard care
- Keywords
- adults
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypocaloric hyperproteic nutritionDietary supplement
Also called Hypocaloric hyperproteic
15 kcal per kg of body weight and 1.7 grams of protein per kg.
Standard careDietary supplement
Also called Isocaloric
25 kcal per kg of body weight
| Study group | Role | What they receive |
|---|---|---|
| Standard care | Active comparator | Patients will receive normal nutritional regime of around 25 kcal per kg. Receives: Dietary Supplement: Standard care |
| Hypocaloric hyperproteic nutrition | Experimental | 15 kcal per kg of body weight and 1.7 grams of protein per kg Receives: Dietary Supplement: Hypocaloric hyperproteic nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 48 hours since nutritional regime starts
Secondary outcomes (1)
Insulin Requirements
This is an indirect measure of glycemic control, and is reported as a daily average.
Measured: Daily until day 21 or discharge from ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2012 (estimated)
- Study startAug 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Critically IllStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lafrancol S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Universitario San Ignacio
- Responsible party
- Sponsor
- Investigators
- Saul Rugeles, MD, Principal investigator, Pontificia Universidad Javeriana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01531335
- Sponsor's protocol ID
- SJ0079
- Acronym
- RuRaL
- Status last verified
- Nov 2015
- First submitted
- 7 Feb 2012
- Last updated
- 11 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Hypocaloric Nutrition Compared With Standard Care in Critically Ill Adults Patients, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01531335
- Acronym / sponsor ID
- RuRaL / SJ0079
- Conditions
- Critically Ill
- Keywords
- adults
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Lafrancol S.A.Industry (pharma, biotech, devices)
- Collaborators
- Hospital Universitario San Ignacio
- Study start
- Aug 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 10 Feb 2012 (estimated)
- Results
- Posted 11 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The research site will be the intensive care unit (ICU) of Hospital Universitario San Ignacio; eligible patients will >18 years of age with a presumed fasting period of at least 96 hours, with no contraindications for enteral nutrition. Patients with parenteral nutrition, pregnancy, diabetes, liver failure, renal failure, transplant protocol, or admitted from another hospital will be excluded. In all patients, the following information will be collected daily: enteral formula in ml, carbohydrate intake, insulin required (in IU), presence of hyper or hypoglicemia, presence of infections, among others.
The SOFA score will be assessed every two days until discharge from ICU.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | Active comparator | Dietary Supplement: Standard carePatients will receive normal nutritional regime of around 25 kcal per kg. |
| Hypocaloric hyperproteic nutrition | Experimental | Dietary Supplement: Hypocaloric hyperproteic nutrition15 kcal per kg of body weight and 1.7 grams of protein per kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- >18 years
- estimated fasting period of at least 96 hours
Key exclusion criteria (6 listed)
- parenteral nutrition
- pregnancy
- diabetes
- liver or renal failure
- transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypocaloric hyperproteic nutritionAlso: Hypocaloric hyperproteic15 kcal per kg of body weight and 1.7 grams of protein per kg. | Dietary supplement | Hypocaloric hyperproteic nutrition |
| Standard careAlso: Isocaloric25 kcal per kg of body weight | Dietary supplement | Standard care |
Primary outcome
SOFA (Sequential Organ Failure Assessment) Score
Time frame: 48 hours since nutritional regime starts
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).
1 secondary outcome
Insulin Requirements
Time frame: Daily until day 21 or discharge from ICU
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saul Rugeles, MD principal investigator
Pontificia Universidad Javeriana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hypocaloric hyperproteic nutrition in people with Critically Ill, run by Lafrancol S.A. at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SOFA (Sequential Organ Failure Assessment) Score (time frame: 48 hours since nutritional regime starts). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2015.