Critically IllPhase 3hipoentnutNCT02577211
Hypocaloric Enteral Nutrition in the Critically Ill Patient
A Phase 3 study testing Hipocaloric enteral nutrition and Normocaloric enteral 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). Both regimes will recive 1,7 g/Kg/dia The main outcome will be the SOFA (sequential organ failure assessment) score. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Critically Ill
- What is being tested?
- Hipocaloric enteral nutrition and Normocaloric enteral nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteColombia
- Study dates
- Dec 2013to Jul 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years
- Estimated fasting period of at least 96 hours
- ICU patients
Who cannot join
- Parenteral nutrition
- Pregnancy
- Diabetes
- Liver failure
- Transplantation or in transplant protocol
- Previous nutrition support
- Chronic Renal failure
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Hospital Universitario San Ignacio
Bogotá, Bogota D.C., 000000
About this study
Official title: Randomized Controlled Trial of Hypocaloric Hyperproteic Enteral Nutrition in the Critically Ill Patient
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.
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
- Hipocaloric enteral nutrition, Normocaloric enteral nutrition
- Keywords
- Critically ill, Enteral nutrition
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hipocaloric enteral nutritionDietary supplement
Also called low caloric delivery
15 kcal/Kg of body weight
Normocaloric enteral nutritionDietary supplement
25 kcal/kg of body weight
| Study group | Role | What they receive |
|---|---|---|
| Hipocaloric enteral nutrition | Experimental | 15 kcal per kg of body weight and 1.7 grams of protein per kg. Receives: Dietary Supplement: Hipocaloric enteral nutrition |
| Normocaloric enteral nutrition | Active comparator | 25 kcal per kg of body weight and 1.7 grams of protein per kg. Receives: Dietary Supplement: Normocaloric enteral nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the intial SOFA (Sequential Organ Failure Assessment) score at 48 hours.
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 after the onset of nutrition
Secondary outcomes (4)
Units of insulin require in a day
This is an indirect measure of glycemic control, and is reported as a daily average of the units of insuline require in the first 4 days since nutritional regimen starts.
Measured: Within the first 4 days after the onset of nutrition
Number of days the patient requires mechanical ventilation.
Measure daily
Measured: Within the first 28 days after the onset of nutrition
Number of days in the intensive care unit
Measure daily
Measured: Within the first 28 days after the onset of nutrition
Mortality to 28 days
We will interview each patient 28 days after the start of the study to assess the global mortality
Measured: 28 days after the onset of nutrition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study startDec 2013
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lafrancol S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Universitario San Ignacio, Pontificia Universidad Javeriana
- Responsible party
- Sponsor
- Investigators
- Saul J Rugeles, MD, Principal investigator, Hospital Universitario San Ignacio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02577211
- Sponsor's protocol ID
- hnrct2
- Acronym
- hipoentnut
- Status last verified
- Nov 2015
- First submitted
- 10 Oct 2015
- Last updated
- 10 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Hypocaloric Hyperproteic Enteral Nutrition in the Critically Ill Patient
- ClinicalTrials.gov ID
- NCT02577211
- Acronym / sponsor ID
- hipoentnut / hnrct2
- Conditions
- Critically Ill
- Keywords
- Critically ill, Enteral nutrition
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Lafrancol S.A.Industry (pharma, biotech, devices)
- Collaborators
- Hospital Universitario San Ignacio, Pontificia Universidad Javeriana
- Study start
- Dec 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 16 Oct 2015 (estimated)
- Results
- Not posted in the source record
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). 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.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hipocaloric enteral nutrition | Experimental | Dietary Supplement: Hipocaloric enteral nutrition15 kcal per kg of body weight and 1.7 grams of protein per kg. |
| Normocaloric enteral nutrition | Active comparator | Dietary Supplement: Normocaloric enteral nutrition25 kcal per kg of body weight and 1.7 grams of protein per kg. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >18 years
- Estimated fasting period of at least 96 hours
- ICU patients
Key exclusion criteria (7 listed)
- Parenteral nutrition
- Pregnancy
- Diabetes
- Liver failure
- Transplantation or in transplant protocol
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 |
|---|---|---|
| Hipocaloric enteral nutritionAlso: low caloric delivery15 kcal/Kg of body weight | Dietary supplement | Hipocaloric enteral nutrition |
| Normocaloric enteral nutrition25 kcal/kg of body weight | Dietary supplement | Normocaloric enteral nutrition |
Primary outcome
Change in the intial SOFA (Sequential Organ Failure Assessment) score at 48 hours.
Time frame: 48 hours after the onset of nutrition
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).
4 secondary outcomes
Units of insulin require in a day
Time frame: Within the first 4 days after the onset of nutrition
Number of days the patient requires mechanical ventilation.
Time frame: Within the first 28 days after the onset of nutrition
Number of days in the intensive care unit
Time frame: Within the first 28 days after the onset of nutrition
Mortality to 28 days
Time frame: 28 days after the onset of nutrition
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2015.
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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 J Rugeles, MD principal investigator
Hospital Universitario San Ignacio
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 Hipocaloric enteral nutrition and Normocaloric enteral 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 3 inclusion and 7 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 10 Nov 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in the intial SOFA (Sequential Organ Failure Assessment) score at 48 hours. (time frame: 48 hours after the onset of nutrition). 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 10 Nov 2015.