Critical IllnessPhase 4ROSIEDNCT01713257
Study of Arginine Free IED in Critically Ill Patients.
A Phase 4 study testing Immunoenhancing diet and Isocaloric, isonitrogenous diet in people with Critical Illness, run by Thai Otsuka Pharmaceutical Co., Ltd. at 3 sites in Thailand.
Trial summary
This study intends to investigate the clinical outcomes of a new immunoenhancing formula which composed arginine free compare to isonitrogenous, isocaloric standard formula in ICU patients.The study design is multicenter, double-blind randomized controlled study with 3 periods of Screening, Run-in and Randomization… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Immunoenhancing diet and Isocaloric, isonitrogenous diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 3 sitesThailand
- Study dates
- Jan 2011to Oct 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ICU patients requiring mechanical ventilation or APACHE II score equal or more than 10
- Patients arrived at ICU within 24 hours before feeding
- Anticipated tube feeding for at least 5 days
- Age of 18 years and older
Who cannot join
- Inability to be fed via the gastrointestinal tract
- Allergic to whey protein isolate (WPI), soy protein isolate, glutamine, fish oil or any components in study formulas
- Hemodynamically unstable, requiring significant dose of vasopressor or inotropes infusion (Dopamine or dobutamine > 5 microgram/kg/min or noradrenaline > 0.1 microgram/kg/min)
- Known insulin dependent diabetes mellitus
- Cerebral hemorrhage or severe head injury (Glasgow Coma Scale Score ≤ 8)
- Active bleeding requiring ongoing blood transfusion
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- Platelet count < 30,000/mm3 or INR > 5
- Pre-existing incurable disease (uncontrolled cancer, terminal disease, patient's legal representative not committed to full support)
- On chemotherapy, radiation therapy within the previous 6 months or immunosuppressive regimen (including prednisolone or aspirin at least 7 days consecutively within the previous 4 weeks) or on other investigational drugs
- Any genetic immune or autoimmune disorder; known HIV-positive patients
- Severe chronic liver disease (Child- Pugh score of 11-15)
- Renal failure requiring renal replacement therapy
- Pregnancy or lactation
- Unable to obtain inform consent from patient or his/her legal representative
Trial locations and contacts
3 sites in 1 country.
Thailand3 sites
Songklanakarind Hospital
Hat Yai, Changwat Songkhla, 90110
Assoc.Prof.Kaweesak Chittawatanarat
Muang, Chiang Mai, 50200
Assoc.Prof.Boonsong Pachanasoonthorn
Muang, Khonkaen
About this study
Official title: A Comparative Randomized Controlled Study of Arginine Free Immunoenhancing Diet and Isocaloric, Isonitrogenous Formula in Critically Ill Patients
This study intends to investigate the clinical outcomes of a new immunoenhancing formula which composed arginine free compare to isonitrogenous, isocaloric standard formula in ICU patients.The study design is multicenter, double-blind randomized controlled study with 3 periods of Screening, Run-in and Randomization period.
Primary Objective: To evaluate the clinical outcomes of immunoenhancing diet (IED) arginine free in medical-surgical ICU patients.
Secondary Objective: To evaluate the immunologic effects and safety of IED arginine free formula.
Read the detailed description
It is accepted that nutrition support is essential in the treatment of critically ill patients. It is also reasonable to initiate nutrition support therapy as soon as possible. Although malnutrition is most frequently associated with a risk for immune dysfunction, it can affect all organ systems. Thus, ICU patients are in need of immunonutrients supplementation. An additional strategy to maximize the benefits is to consider using products supplemented with specific nutrients that modulate the immune system, improve wound healing, and reduce oxidative stress. The lower incidence of infectious complications may follow in shorter lengths of both intensive care units (ICU) and hospital stays. Many studies have concentrated on nutrients to stimulate the function of cellular immunity in these patients. These nutrients include arginine, glutamine and omega-3 fatty acid which has direct effect on T lymphocytes and macrophage. Enteral formulas designed as immune-enhancing diets (IED) contain supplemental amounts of L-arginine, L-glutamine, nucleotides and the long chain polyunsaturated fatty acids: eicosapentaenoic acid (EPA), docosahexanoic acid (DHA) and arachidonic acid (ARA) in addition to nutrient substrates essential for general nutrition and metabolism. These formulas vary considerably in composition of these four primary substrates. They introduce the immune cell function augmentation, inflammation regulation and infections minimization. Glutamine, a conditional-essential amino acid, an essential energy source, a precursor for protein synthesis and donates nitrogen for the synthesis of purines, pyrimidines, nucleotides, amino sugars, and glutathione antioxidant.
Glutamine also plays an important role in enhancing immune cell function with no elevation in proinflammatory cytokine production. The lower levels of glutamine have been associated with impaired tissue healing, immune dysfunction and increased mortality.
Omega-3 fatty acid (n-3 fatty acid or omega-3 fatty acid) directly affects the function of monocyte by membrane characteristic alteration, prostaglandin E2 (PGE2) synthesis that has the action of macrophage phagocytosis, IL-1 and superoxide synthesis. Moreover, omega-3 fatty acid reduces cellular immune response reaction by compete arachidonic acid resulting in less inflammation.
Arginine is considered a nutrient that enhances the immune response. Studies have shown arginine-supplemented immune formulas in helping decrease protein catabolism, improve nitrogen balance, enhance wound healing and wound strength resulted in less infection and shorter hospitalization days. Arginine has also been shown to support the immune system by enhancing lymphocyte proliferation and phagocytosis. Arginine may provide some benefits. However, recent meta-analysis conducted in a subgroup of critically ill patients by Heyland and colleagues revealed that arginine may be harmful to some group especially septic patients by stimulating nitric oxide (NO) production.
Based on these scientific rationales, it is recommended that arginine should not be used in critically ill patients who are clearly septic. And many evidences exist for supplementation with antioxidant and immunonutrition in the critically ill. Glutamine and fish oil/borage oil should be considered. These result in the development of immune-enhancing diet (IED) without arginine. In addition, two types of lipids are added into the formula to further modulate immune response. First, fish oil as a source of omega-3 fatty acids and borage oil as a source of docosahexanoic acid (DHA), a unique omega-6 fatty acid (n-6 fatty acid). Both n-3 and n-6 fatty acids are polyunsaturated fatty acids (PUFAs) and are essential fatty acids (EFA). Therefore, immune-enhancing diet composes of L-glutamine, eicosapentaenoic acid (EPA), docosahexanoic acid (DHA), antioxidant vitamins and trace minerals such as vitamin A, vitamin E, vitamin C, selenium and betacarotene.
- Conditions
- Critical Illness
- Being tested
- Immunoenhancing diet, Isocaloric, isonitrogenous diet
- Keywords
- Critically ill patients
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunoenhancing dietDietary supplement
Enteral feeding until Day 10 or the day of discharge if earlier than Day 10. The goal of caloric intake is 25 kcal/kg/day and protein 1.2 g/kg/day.
Isocaloric, isonitrogenous dietDietary supplement
Enteral feeding until Day 10 or the day of discharge if earlier than Day 10. The goal of caloric intake is 25 kcal/kg/day and protein 1.2 g/kg/day.
| Study group | Role | What they receive |
|---|---|---|
| Immunoenhancing diet | Experimental | Immunoenhancing diet feeding until Day 10 or the day of discharge if earlier than Day 10. The goal of caloric intake is 25 kcal/kg/day and protein 1.2 g/kg/day. Receives: Dietary Supplement: Immunoenhancing diet |
| Isocaloric, isonitrogenous diet | Active comparator | Enteral feeding until Day 10 or the day of discharge if earlier than Day 10. The goal of caloric intake is 25 kcal/kg/day and protein 1.2 g/kg/day. Receives: Dietary Supplement: Isocaloric, isonitrogenous diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of new organ failure
Development of new organ failure: cardiovascular, respiratory, renal, hematologic, hepatic, neurologic Clinical outcomes: Change of SOFA score or MODS
Measured: 10 days
Secondary outcomes (1)
Immunologic parameters
Immunologic: IL6, IL10, TNF-alpha Hospitalization day parameters: length of stay 28-day mortality Safety and tolerance; Nutritional parameters: caloric intake, body weight, nitrogen balance, serum albumin, electrolytes, minerals, serum chemistries GI complications: vomiting, diarrhea, constipation, abdominal distension, aspiration Infection complications (other than baseline): wound infection, pneumonia, urinary tract infection, intra-abdominal abscess and bacteremia
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2012 (estimated)
- Study startJan 2011
- Primary completionOct 2012
- Study completionOct 2012
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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thai Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Assist.Prof.Boonsong Pajanasoontorn, MD, Principal investigator, Khon Kaen UniversityKaweesak Chittawatanarat, M.D., Principal investigator, Faculty of Medicine, Chiang Mai UniversityBurapat Sangthong, M.D., Principal investigator, Department of Surgery, Faculty of Medicine, Songklanagarind UniversityRungsun Bhurayanontachai, M.D., Principal investigator, Department of Medicine, Faculty of Medicine, Songklanakarind University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01713257
- Sponsor's protocol ID
- CNN-TOP-2010-01
- Acronym
- ROSIED
- Status last verified
- Oct 2012
- First submitted
- 22 Oct 2012
- Last updated
- 24 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Randomized Controlled Study of Arginine Free Immunoenhancing Diet and Isocaloric, Isonitrogenous Formula in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT01713257
- Acronym / sponsor ID
- ROSIED / CNN-TOP-2010-01
- Conditions
- Critical Illness
- Keywords
- Critically ill patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Thai Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 24 Oct 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.
This study intends to investigate the clinical outcomes of a new immunoenhancing formula which composed arginine free compare to isonitrogenous, isocaloric standard formula in ICU patients.The study design is multicenter, double-blind randomized controlled study with 3 periods of Screening, Run-in and Randomization period.
Primary Objective: To evaluate the clinical outcomes of immunoenhancing diet (IED) arginine free in medical-surgical ICU patients.
Secondary Objective: To evaluate the immunologic effects and safety of IED arginine free formula.
Detailed description
It is accepted that nutrition support is essential in the treatment of critically ill patients. It is also reasonable to initiate nutrition support therapy as soon as possible. Although malnutrition is most frequently associated with a risk for immune dysfunction, it can affect all organ systems. Thus, ICU patients are in need of immunonutrients supplementation. An additional strategy to maximize the benefits is to consider using products supplemented with specific nutrients that modulate the immune system, improve wound healing, and reduce oxidative stress. The lower incidence of infectious complications may follow in shorter lengths of both intensive care units (ICU) and hospital stays. Many studies have concentrated on nutrients to stimulate the function of cellular immunity in these patients. These nutrients include arginine, glutamine and omega-3 fatty acid which has direct effect on T lymphocytes and macrophage. Enteral formulas designed as immune-enhancing diets (IED) contain supplemental amounts of L-arginine, L-glutamine, nucleotides and the long chain polyunsaturated fatty acids: eicosapentaenoic acid (EPA), docosahexanoic acid (DHA) and arachidonic acid (ARA) in addition to nutrient substrates essential for general nutrition and metabolism. These formulas vary considerably in composition of these four primary substrates. They introduce the immune cell function augmentation, inflammation regulation and infections minimization. Glutamine, a conditional-essential amino acid, an essential energy source, a precursor for protein synthesis and donates nitrogen for the synthesis of purines, pyrimidines, nucleotides, amino sugars, and glutathione antioxidant.
Glutamine also plays an important role in enhancing immune cell function with no elevation in proinflammatory cytokine production. The lower levels of glutamine have been associated with impaired tissue healing, immune dysfunction and increased mortality.
Omega-3 fatty acid (n-3 fatty acid or omega-3 fatty acid) directly affects the function of monocyte by membrane characteristic alteration, prostaglandin E2 (PGE2) synthesis that has the action of macrophage phagocytosis, IL-1 and superoxide synthesis. Moreover, omega-3 fatty acid reduces cellular immune response reaction by compete arachidonic acid resulting in less inflammation.
Arginine is considered a nutrient that enhances the immune response. Studies have shown arginine-supplemented immune formulas in helping decrease protein catabolism, improve nitrogen balance, enhance wound healing and wound strength resulted in less infection and shorter hospitalization days. Arginine has also been shown to support the immune system by enhancing lymphocyte proliferation and phagocytosis. Arginine may provide some benefits. However, recent meta-analysis conducted in a subgroup of critically ill patients by Heyland and colleagues revealed that arginine may be harmful to some group especially septic patients by stimulating nitric oxide (NO) production.
Based on these scientific rationales, it is recommended that arginine should not be used in critically ill patients who are clearly septic. And many evidences exist for supplementation with antioxidant and immunonutrition in the critically ill. Glutamine and fish oil/borage oil should be considered. These result in the development of immune-enhancing diet (IED) without arginine. In addition, two types of lipids are added into the formula to further modulate immune response. First, fish oil as a source of omega-3 fatty acids and borage oil as a source of docosahexanoic acid (DHA), a unique omega-6 fatty acid (n-6 fatty acid). Both n-3 and n-6 fatty acids are polyunsaturated fatty acids (PUFAs) and are essential fatty acids (EFA). Therefore, immune-enhancing diet composes of L-glutamine, eicosapentaenoic acid (EPA), docosahexanoic acid (DHA), antioxidant vitamins and trace minerals such as vitamin A, vitamin E, vitamin C, selenium and betacarotene.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immunoenhancing diet | Experimental | Dietary Supplement: Immunoenhancing dietImmunoenhancing diet feeding until Day 10 or the day of discharge if earlier than Day 10. The goal of caloric intake is 25 kcal/kg/day and protein 1.2 g/kg/day. |
| Isocaloric, isonitrogenous diet | Active comparator | Dietary Supplement: Isocaloric, isonitrogenous dietEnteral feeding until Day 10 or the day of discharge if earlier than Day 10. The goal of caloric intake is 25 kcal/kg/day and protein 1.2 g/kg/day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ICU patients requiring mechanical ventilation or APACHE II score equal or more than 10
- Patients arrived at ICU within 24 hours before feeding
- Anticipated tube feeding for at least 5 days
- Age of 18 years and older
Key exclusion criteria (14 listed)
- Inability to be fed via the gastrointestinal tract
- Allergic to whey protein isolate (WPI), soy protein isolate, glutamine, fish oil or any components in study formulas
- Hemodynamically unstable, requiring significant dose of vasopressor or inotropes infusion (Dopamine or dobutamine > 5 microgram/kg/min or noradrenaline > 0.1 microgram/kg/min)
- Known insulin dependent diabetes mellitus
- Cerebral hemorrhage or severe head injury (Glasgow Coma Scale Score ≤ 8)
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 |
|---|---|---|
| Immunoenhancing dietEnteral feeding until Day 10 or the day of discharge if earlier than Day 10. The goal of caloric intake is 25 kcal/kg/day and protein 1.2 g/kg/day. | Dietary supplement | Immunoenhancing diet |
| Isocaloric, isonitrogenous dietEnteral feeding until Day 10 or the day of discharge if earlier than Day 10. The goal of caloric intake is 25 kcal/kg/day and protein 1.2 g/kg/day. | Dietary supplement | Isocaloric, isonitrogenous diet |
Primary outcome
Development of new organ failure
Time frame: 10 days
Development of new organ failure: cardiovascular, respiratory, renal, hematologic, hepatic, neurologic Clinical outcomes: Change of SOFA score or MODS
1 secondary outcome
Immunologic parameters
Time frame: 10 days
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 24 Oct 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.
Assist.Prof.Boonsong Pajanasoontorn, MD principal investigator
Khon Kaen University
Kaweesak Chittawatanarat, M.D. principal investigator
Faculty of Medicine, Chiang Mai University
Burapat Sangthong, M.D. principal investigator
Department of Surgery, Faculty of Medicine, Songklanagarind University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Immunoenhancing diet and Isocaloric, isonitrogenous diet in people with Critical Illness, run by Thai Otsuka Pharmaceutical Co., Ltd. at 3 sites in Thailand.
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 14 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 24 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Thailand. 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 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?
Development of new organ failure (time frame: 10 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 24 Oct 2012.