Enteral FeedingNCT01665664
Hypocaloric vs. Full Energy Enteral Feeding in Critically Ill Patients
A study testing Hypocaloric feeding in people with Enteral Feeding, run by Wolfson Medical Center at 1 site in Israel.
Trial summary
Underfeeding in the critically ill patient is a common observable fact throughout intensive care units. Patients who develop caloric deficit during their stay in the ICU have been shown in previous reports to be associated with increased complications such as increased rate of infections, and nosocomial blood stream… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Enteral Feeding
- What is being tested?
- Hypocaloric feeding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2012to Oct 2013
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Anticipated Mechanical ventilation for at least 72 hrs.
- Need for enteral feeding
- men and woman aged 18 or older.
Who cannot join
- Abdominal surgery with inability to feed enterally.
- FiO2 greater than 80%
- Bronchopleural fistula
- Hemodynamic instability in spite the use of vassopressors.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Wolfson MC
Holon, 58100
Arie Soroksky, MD, 972-50-4056787, soroksky@gmail.com
Arie Soroksky, MD
About this study
Official title: Hypocaloric vs. Full Energy Enteral Feeding in Critically Ill Patients Guided by Indirect Calorimetry, a Prospective, Blinded, Randomized Controlled Trial.
Underfeeding in the critically ill patient is a common observable fact throughout intensive care units. Patients who develop caloric deficit during their stay in the ICU have been shown in previous reports to be associated with increased complications such as increased rate of infections, and nosocomial blood stream infections. Yet, other studies have shown that patients with moderate caloric deficit may be associated with better outcome than patients who receive higher levels of caloric intake.
Read the detailed description
Therefore, the aim of our study is to establish the exact amount of calories to be delivered by indirect calorimetry individually for each patient. Thereafter, each patient will be randomized to the trophic group (hypocaloric feeding), or to the full energy delivery group.
- Conditions
- Enteral Feeding
- Being tested
- Hypocaloric feeding
- Keywords
- Indirect calorimetry, hypocaloric feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypocaloric feedingOther
Also called trophic group
Daily calorimetry for the first 6 days will be performed with determination of REE and the required amount of calories needed for the next 24 hours. In this group only 20% of REE will be provided but not less than 300 kcal/day.
| Study group | Role | What they receive |
|---|---|---|
| Hypocaloric feeding group | Other | intervention - Daily calorimetry for the first 6 days will be performed with determination of REE and the required amount of calories needed for the next 24 hours. In this group only 20% of REE will be provided but not less than 300 kcal/day. Receives: Other: Hypocaloric feeding |
| Full energy feeding group | No intervention | Daily calorimetry for the first 6 days will be performed with determination of REE and the required amount of calories needed for the next 24 hours. In this group only 100% of REE will be provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality, ICU mortality, Hospital mortality.
All cause mortality, ICU mortality, Hospital mortality.
Measured: 1 year
Secondary outcomes (1)
ICU and Hospital LOS, Length of mechanical ventilation, rate of infections,
ICU LOS, Hospital LOS, Length of mechanical ventilation, ventilation free days, rate of infections, rate of ventilator associated pneumonia,
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2013 (estimated)
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enteral FeedingStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Soroksky Arie, Wolfson Medical Center
- Investigators
- Arie Soroksky, MD, Principal investigator, Wolfson MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01665664
- Sponsor's protocol ID
- 0014-12-WOMC
- Status last verified
- Aug 2012
- First submitted
- 13 Aug 2012
- Last updated
- 15 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypocaloric vs. Full Energy Enteral Feeding in Critically Ill Patients Guided by Indirect Calorimetry, a Prospective, Blinded, Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01665664
- Acronym / sponsor ID
- 0014-12-WOMC
- Conditions
- Enteral Feeding
- Keywords
- Indirect calorimetry, hypocaloric feeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- Sep 2012
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 15 Aug 2012 (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.
Underfeeding in the critically ill patient is a common observable fact throughout intensive care units. Patients who develop caloric deficit during their stay in the ICU have been shown in previous reports to be associated with increased complications such as increased rate of infections, and nosocomial blood stream infections. Yet, other studies have shown that patients with moderate caloric deficit may be associated with better outcome than patients who receive higher levels of caloric intake.
Detailed description
Therefore, the aim of our study is to establish the exact amount of calories to be delivered by indirect calorimetry individually for each patient. Thereafter, each patient will be randomized to the trophic group (hypocaloric feeding), or to the full energy delivery group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypocaloric feeding group | Other | Other: Hypocaloric feedingintervention - Daily calorimetry for the first 6 days will be performed with determination of REE and the required amount of calories needed for the next 24 hours. In this group only 20% of REE will be provided but not less than 300 kcal/day. |
| Full energy feeding group | No intervention | –Daily calorimetry for the first 6 days will be performed with determination of REE and the required amount of calories needed for the next 24 hours. In this group only 100% of REE will be provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Anticipated Mechanical ventilation for at least 72 hrs.
- Need for enteral feeding
- men and woman aged 18 or older.
Key exclusion criteria (4 listed)
- Abdominal surgery with inability to feed enterally.
- FiO2 greater than 80%
- Bronchopleural fistula
- Hemodynamic instability in spite the use of vassopressors.
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 feedingAlso: trophic groupDaily calorimetry for the first 6 days will be performed with determination of REE and the required amount of calories needed for the next 24 hours. In this group only 20% of REE will be provided but not less than 300 kcal/day. | Other | Hypocaloric feeding group |
Primary outcome
All cause mortality, ICU mortality, Hospital mortality.
Time frame: 1 year
All cause mortality, ICU mortality, Hospital mortality.
1 secondary outcome
ICU and Hospital LOS, Length of mechanical ventilation, rate of infections,
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2012.
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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.
Arie Soroksky, MD principal investigator
Wolfson MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypocaloric feeding in people with Enteral Feeding, run by Wolfson Medical Center at 1 site in Israel.
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 4 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: status not confirmed, as of the sponsor's last update on 15 Aug 2012. 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 Israel. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arie Soroksky, M.D. (972-50-4056787, soroksky@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality, ICU mortality, Hospital mortality. (time frame: 1 year). 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 15 Aug 2012.