Critical IllnessPhase 4NCT03003507
Glycemic Index Variation During Low-carbohydrate Enteral Formula With and Without Fructose in Critically Ill Patients
A Phase 4 study testing Enteral Formula With Fructose and Enteral Formula Without Fructose in people with Critical Illness, run by Hospital Moinhos de Vento.
Trial summary
Hyperglycemia is a known risk factor for mortality in critically ill patients. Most of these patients receive enteral feeding. There is controversy about ideal carbohydrate composition of these diets. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Enteral Formula With Fructose and Enteral Formula Without Fructose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Apr 2013
- Phase
- Phase 4
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Critical Illness
- Exclusive enteral diet
- Enteral diet with full nutritional value
- Hyperglycemia ≥180 mg / dl
Who cannot join
- Oral feeding
- NPT (Total or Partial Parenteral Nutrition)
- Patient without indication of use of study diets
About this study
Official title: Glycemic Index Variation During Low-carbohydrate Enteral Formula With and Without Fructose in Critically Ill Patients: A Cross-over Randomized Clinical Trial
Hyperglycemia is a known risk factor for mortality in critically ill patients. Most of these patients receive enteral feeding. There is controversy about ideal carbohydrate composition of these diets. The aim of this study was to compare an enteral formula with the same proportion of carbohydrates with and without fructose on blood glucose levels.
Read the detailed description
Randomized, cross-over, controlled, double-blind clinical trial without washout. Adult patients admitted to the ICU who presented capillary glycemia values> 180mg / dl with a full and exclusive enteral diet. They were randomized and observed for 4 days (2 days with each diet: with / without fructose). Capillary glycemia was measured 4 / 4h.
- Conditions
- Critical Illness
- Being tested
- Enteral Formula With Fructose, Enteral Formula Without Fructose
- Keywords
- Hyperglycemia, Fructose, Diabetes mellitus, Enteral Nutrition, Glycemic Variability
- Medical subject headings
- Critical Illness, Hyperglycemia, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enteral Formula With FructoseDietary supplement
Low-carbohydrate Enteral Formula With Fructose
Enteral Formula Without FructoseDietary supplement
Low-carbohydrate Enteral Formula Without Fructose
| Study group | Role | What they receive |
|---|---|---|
| Diet 1 | Active comparator | Low-carbohydrate Enteral Formula With Fructose Receives: Dietary Supplement: Enteral Formula With Fructose |
| Diet 2 | Active comparator | Low-carbohydrate Enteral Formula Without Fructose Receives: Dietary Supplement: Enteral Formula Without Fructose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Variability
To evaluate the glycemic oscillation during the use of enteral feedings
Measured: four days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2016 (estimated)
- Study startOct 2009
- Primary completionApr 2011
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Moinhos de Vento
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magali Kumbier, Hospital Moinhos de Vento
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03003507
- Sponsor's protocol ID
- v4n3n8xw
- Status last verified
- Dec 2016
- First submitted
- 22 Dec 2016
- Last updated
- 28 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic Index Variation During Low-carbohydrate Enteral Formula With and Without Fructose in Critically Ill Patients: A Cross-over Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03003507
- Acronym / sponsor ID
- v4n3n8xw
- Conditions
- Critical Illness
- Keywords
- Hyperglycemia, Fructose, Diabetes mellitus, Enteral Nutrition, Glycemic Variability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Hospital Moinhos de VentoUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 28 Dec 2016 (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.
Hyperglycemia is a known risk factor for mortality in critically ill patients. Most of these patients receive enteral feeding. There is controversy about ideal carbohydrate composition of these diets. The aim of this study was to compare an enteral formula with the same proportion of carbohydrates with and without fructose on blood glucose levels.
Detailed description
Randomized, cross-over, controlled, double-blind clinical trial without washout. Adult patients admitted to the ICU who presented capillary glycemia values> 180mg / dl with a full and exclusive enteral diet. They were randomized and observed for 4 days (2 days with each diet: with / without fructose). Capillary glycemia was measured 4 / 4h.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet 1 | Active comparator | Dietary Supplement: Enteral Formula With FructoseLow-carbohydrate Enteral Formula With Fructose |
| Diet 2 | Active comparator | Dietary Supplement: Enteral Formula Without FructoseLow-carbohydrate Enteral Formula Without Fructose |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Critical Illness
- Exclusive enteral diet
- Enteral diet with full nutritional value
- Hyperglycemia ≥180 mg / dl
Key exclusion criteria (3 listed)
- Oral feeding
- NPT (Total or Partial Parenteral Nutrition)
- Patient without indication of use of study diets
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 |
|---|---|---|
| Enteral Formula With FructoseLow-carbohydrate Enteral Formula With Fructose | Dietary supplement | Diet 1 |
| Enteral Formula Without FructoseLow-carbohydrate Enteral Formula Without Fructose | Dietary supplement | Diet 2 |
Primary outcome
Glycemic Variability
Time frame: four days
To evaluate the glycemic oscillation during the use of enteral feedings
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 28 Dec 2016.
- Individual participant dataSharing planned: No
Related trials for Critical Illness
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Enteral Formula With Fructose and Enteral Formula Without Fructose in people with Critical Illness, run by Hospital Moinhos de Vento.
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 4 inclusion and 3 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 28 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Glycemic Variability (time frame: four days). 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 28 Dec 2016.