Critical IllnessPhase 3NCT01162928
Parenteral Nutrition With Intravenous and Oral Fish Oil for Intensive Care Patients
A Phase 3 study testing Nutriflex Omega special + Oxepa and Nutriflex Lipid special + Pulmocare in people with Critical Illness, run by B. Braun Melsungen AG at 1 site in Israel.
Trial summary
The primary objective is to assess the effect of fish oil-enriched enteral and parenteral nutrition on blood oxygenation in critically ill patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Critical Illness
- What is being tested?
- Nutriflex Omega special + Oxepa and Nutriflex Lipid special + Pulmocare
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- May 2013to Nov 2017
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- mechanically-ventilated adults (age 18-80) admitted to Intensive Care Unit,
- enteral nutrition does not meet the nutrition goal (at least 80 % of the resting energy expenditure) within the past 36 hours
- APACHE II score above the median value of the intensive care unit (id est > 20)
Who cannot join
- cardiogenic pulmonary edema
- previous (< 1 month) or ongoing need for corticosteroids > 0.1 mg/kg prednisolon- equi-valent or other immune suppressive treatment
- serum triglycerides > 300 mg/dl at screening
- alterations of coagulation (platelets <100.000 mm3), PTT > 60 sec, INR ≥ 2.5 without therapeutic intervention
- pregnancy
- participation in a clinical study with an investigational drug within one month prior to the start of this clinical trial
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- known or suspected drug abuse
- general contraindications for infusion therapy such as acute pulmonary oedema, hyper-hydration and decompensated cardiac insufficiency
- known hypersensitivity to egg-, soy-, and fish proteins or any of the ingredients
- autoimmune disease or HIV
- uncompensated hemodynamical failure of any origin (hemorrhagic shock, myocardial infarction, cardiac failure)
- uncompensated ketoacidosis caused by Diabetes mellitus within 7 days prior to onset of study
- uncompensated renal insufficiency with serum creatinine > 1.5 mg/dL (> 133 µmol/L)
- patients with severe liver dysfunction with bilirubin > 2.5 mg/dL (> 43 µmol/L)
- necrotizing pancreatitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Benefit From Combined Administration of Oral and Intravenous Nutrition - Enriched With Omega-3 Fatty Acids - for Intensive Care Patient
The primary objective is to assess the effect of fish oil-enriched enteral and parenteral nutrition on blood oxygenation in critically ill patients.
- Conditions
- Critical Illness
- Being tested
- Nutriflex Omega special + Oxepa, Nutriflex Lipid special + Pulmocare
- Keywords
- critically ill, mechanically ventilated patients requiring enteral and parenteral nutritional support
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutriflex Omega special + OxepaDrug
3-chamber-bag combined with enteral nutrition
Nutriflex Lipid special + PulmocareDrug
3-chamber-bag combined with enteral nutrition
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 3-chamber-bag combined with Oxepa Receives: Drug: Nutriflex Omega special + Oxepa |
| 2 | Active comparator | 3-chamber-bag combined with Pulmocare Receives: Drug: Nutriflex Lipid special + Pulmocare |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in blood oxygenation (PaO2/FIO2 ratio)
Measured: day 1 to day 6
Secondary outcomes (4)
rate of parenteral nutrition associated complications equal or better compared to current practice
Measured: day 1 to day 6
disease related complications
Measured: Day 28
28 day-mortality
Measured: Day 28
changes in fatty acid composition of cell membranes
Measured: Day 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2010 (estimated)
- Study startMay 2013
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- B. Braun Melsungen AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pierre Singer, MD, Principal investigator, Rabin Medical Center, Beilinson Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01162928
- Sponsor's protocol ID
- HC-G-H-0804
- Status last verified
- Apr 2018
- First submitted
- 14 Jul 2010
- Last updated
- 27 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Singer P, Bendavid I, Mesilati-Stahy R, Green P, Rigler M, Lev S, Schif-Zuck S, Amiram A, Theilla M, Kagan I. Enteral and supplemental parenteral nutrition enriched with omega-3 polyunsaturated fatty acids in intensive care patients - A randomized, controlled, double-blind clinical trial. Clin Nutr. 2021 May;40(5):2544-2554. doi: 10.1016/j.clnu.2021.03.034. Epub 2021 Apr 1.
PubMed 33932802
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Benefit From Combined Administration of Oral and Intravenous Nutrition - Enriched With Omega-3 Fatty Acids - for Intensive Care Patient
- ClinicalTrials.gov ID
- NCT01162928
- Acronym / sponsor ID
- HC-G-H-0804
- Conditions
- Critical Illness
- Keywords
- critically ill, mechanically ventilated patients requiring enteral and parenteral nutritional support
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- B. Braun Melsungen AGIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 15 Jul 2010 (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 primary objective is to assess the effect of fish oil-enriched enteral and parenteral nutrition on blood oxygenation in critically ill patients.
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 |
|---|---|---|
| 1 | Experimental | Drug: Nutriflex Omega special + Oxepa3-chamber-bag combined with Oxepa |
| 2 | Active comparator | Drug: Nutriflex Lipid special + Pulmocare3-chamber-bag combined with Pulmocare |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- mechanically-ventilated adults (age 18-80) admitted to Intensive Care Unit,
- enteral nutrition does not meet the nutrition goal (at least 80 % of the resting energy expenditure) within the past 36 hours
- APACHE II score above the median value of the intensive care unit (id est > 20)
Key exclusion criteria (15 listed)
- cardiogenic pulmonary edema
- previous (< 1 month) or ongoing need for corticosteroids > 0.1 mg/kg prednisolon- equi-valent or other immune suppressive treatment
- serum triglycerides > 300 mg/dl at screening
- alterations of coagulation (platelets <100.000 mm3), PTT > 60 sec, INR ≥ 2.5 without therapeutic intervention
- pregnancy
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 |
|---|---|---|
| Nutriflex Omega special + Oxepa3-chamber-bag combined with enteral nutrition | Drug | 1 |
| Nutriflex Lipid special + Pulmocare3-chamber-bag combined with enteral nutrition | Drug | 2 |
Primary outcome
change in blood oxygenation (PaO2/FIO2 ratio)
Time frame: day 1 to day 6
4 secondary outcomes
rate of parenteral nutrition associated complications equal or better compared to current practice
Time frame: day 1 to day 6
disease related complications
Time frame: Day 28
28 day-mortality
Time frame: Day 28
changes in fatty acid composition of cell membranes
Time frame: Day 12
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 27 Apr 2018.
- Derived from this study: PubMed 33932802Singer P, Bendavid I, Mesilati-Stahy R, Green P, Rigler M, Lev S, Schif-Zuck S, Amiram A, Theilla M, Kagan I. Enteral and supplemental parenteral nutrition enriched with omega-3 polyunsaturated fatty acids in intensive care patients - A randomized, controlled, double-blind clinical trial. Clin Nutr. 2021 May;40(5):2544-2554. doi: 10.1016/j.clnu.2021.03.034. Epub 2021 Apr 1.
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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.
Pierre Singer, MD principal investigator
Rabin Medical Center, Beilinson Campus
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 Nutriflex Omega special + Oxepa and Nutriflex Lipid special + Pulmocare in people with Critical Illness, run by B. Braun Melsungen AG 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 15 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 27 Apr 2018. 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.
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 blood oxygenation (PaO2/FIO2 ratio) (time frame: day 1 to day 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01162928, which also lists 1 linked publication.
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 27 Apr 2018.