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| Name | Class |
|---|---|
| Israeli Ministry of Security | UNKNOWN |
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This is a single-center, prospective, randomized, comparative, double-blind controlled clinical study mend to assess the effect of enteral feeding with Oxepa (a fish oil-based nutrition), compared to an isocaloric control, on oxygenation and clinical outcomes in mechanically ventilated trauma patients.
The study population will be adults admitted to the ICU due to multiple-trauma or head trauma as a result of a gun shut, motor vehicle accidents, fall, workplace accident etc.
Primary outcome:
Improvement in oxygenation
Secondary outcomes:
Significant improvement in other clinical and laboratory end points.
Primary endpoint:
Pulmonary function:
Oxygenation (PO2- FIO2 ratio)
Secondary endpoints:
Rate of complications:
-New organ failure.
Rate of new infections:
-wound infection, bacteremia, ventilation associated pneumonia.
Pain:
-Pain score and analgesic use
Morbidity/ mortality:
All patients will commence enteral feeding via a nasogastric or orogastric tube; allocation to either Oxepa or Pulmocare/Jevity (control group) will be determined by randomization code. Patients will be prescribed to receive a daily amount of enteral formula that provides at least 80% of their energy; the latter will be calculated every 48 to 72 hours by Indirect Calorimetric (IC) measurement of Resting Energy Expenditure (REE). Tolerance of EN will be assessed by measurement of Gastric Residual Volume (GRV) every 8 hrs and the mode of feeding will be modified accordingly.
Treatment:
Enrolled patients will be randomly divided into a control group and an intervention group.
Control group treatment:
Will be administered Pulmocare or Jevity (enteral nutrition formula, ABBOTT), at a dose determined by a patient's energy expenditure and tolerance of enteral feeding.
Intervention group treatment:
Will be administered with Oxepa (enteral nutrition formula, ABBOTT), at a dose determined by a patient's energy expenditure and tolerance of enteral feeding.
Treatment duration:
The above formulas will be/delivered until the first of the following occurs:
Study termination (end of all study procedures):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxepa | Active Comparator | Oxepa (enteral nutrition formula, ABBOTT)will be administered at a dose determined by a patient's energy expenditure and tolerance of enteral feeding. |
|
| Control group | Active Comparator | Pulmocare or Jevity (enteral nutrition formula, ABBOTT)will be administered at a dose determined by a patient's energy expenditure and tolerance of enteral feeding. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxepa (enteral nutrition formula, ABBOTT), at a dose determined by a patient's energy expenditure and tolerance of enteral feeding. | Dietary Supplement | Oxepa will be administered(enteral nutrition formula, ABBOTT), at a dose determined by a patient's energy expenditure and tolerance of enteral feeding |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygenation (PO2/FIO2 ratio) | PO2/FIO2 ratio; assessed by measuring arterial blood gases (AVL Omni Technology, Graz, Austria) and ventilator settings (10) | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| TNF-α, CRP (markers of inflammatory response) | Concentration of circulating inflammatory markers: TNF-α, CRP concentrations | 2 years |
| Fatty acid composition of RBC phospholipids, including n-3:n-6 ratio (markers of n-3 PUFA incorporation into blood cell membranes) |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pierre Singer, Principal Investigator MD | Contact | 972-3-9376521 | psinger@clalit.org.il |
| Name | Affiliation | Role |
|---|---|---|
| Pierre Singer, MD, Professor | Rabin Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rabin Medical Center, Campus Beilinson | Recruiting | Petah Tikva | 49100 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15659944 | Background | MacCallum NS, Evans TW. Epidemiology of acute lung injury. Curr Opin Crit Care. 2005 Feb;11(1):43-9. doi: 10.1097/00075198-200502000-00007. | |
| 7509706 | Background | Bernard GR, Artigas A, Brigham KL, Carlet J, Falke K, Hudson L, Lamy M, Legall JR, Morris A, Spragg R. The American-European Consensus Conference on ARDS. Definitions, mechanisms, relevant outcomes, and clinical trial coordination. Am J Respir Crit Care Med. 1994 Mar;149(3 Pt 1):818-24. doi: 10.1164/ajrccm.149.3.7509706. |
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| ID | Term |
|---|---|
| D009104 | Multiple Trauma |
| D006259 | Craniocerebral Trauma |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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|
| oxepa | Dietary Supplement | A dose determined by a patient's energy expenditure and tolerance of enteral feeding. |
|
| Control group | Dietary Supplement | Pulmocare or Jevity (enteral nutrition formula, ABBOTT)will be administered at a dose determined by a patient's energy expenditure and tolerance of enteral feeding. |
|
Fatty acid composition of RBC membrane (thin liquid chromatography) |
| 2 years |
| 2501509 | Background | Moore FA, Moore EE, Jones TN, McCroskey BL, Peterson VM. TEN versus TPN following major abdominal trauma--reduced septic morbidity. J Trauma. 1989 Jul;29(7):916-22; discussion 922-3. doi: 10.1097/00005373-198907000-00003. |
| 1616387 | Background | Kudsk KA, Croce MA, Fabian TC, Minard G, Tolley EA, Poret HA, Kuhl MR, Brown RO. Enteral versus parenteral feeding. Effects on septic morbidity after blunt and penetrating abdominal trauma. Ann Surg. 1992 May;215(5):503-11; discussion 511-3. doi: 10.1097/00000658-199205000-00013. |
| 8857857 | Background | Kudsk KA, Minard G, Croce MA, Brown RO, Lowrey TS, Pritchard FE, Dickerson RN, Fabian TC. A randomized trial of isonitrogenous enteral diets after severe trauma. An immune-enhancing diet reduces septic complications. Ann Surg. 1996 Oct;224(4):531-40; discussion 540-3. doi: 10.1097/00000658-199610000-00011. |
| 7932892 | Background | Moore FA, Moore EE, Kudsk KA, Brown RO, Bower RH, Koruda MJ, Baker CC, Barbul A. Clinical benefits of an immune-enhancing diet for early postinjury enteral feeding. J Trauma. 1994 Oct;37(4):607-15. doi: 10.1097/00005373-199410000-00014. |
| 19005311 | Background | Todd SR, Gonzalez EA, Turner K, Kozar RA. Update on postinjury nutrition. Curr Opin Crit Care. 2008 Dec;14(6):690-5. doi: 10.1097/MCC.0b013e3283196562. |
| 16484911 | Background | Singer P, Theilla M, Fisher H, Gibstein L, Grozovski E, Cohen J. Benefit of an enteral diet enriched with eicosapentaenoic acid and gamma-linolenic acid in ventilated patients with acute lung injury. Crit Care Med. 2006 Apr;34(4):1033-8. doi: 10.1097/01.CCM.0000206111.23629.0A. |
| 16243493 | Background | Green P, Hermesh H, Monselise A, Marom S, Presburger G, Weizman A. Red cell membrane omega-3 fatty acids are decreased in nondepressed patients with social anxiety disorder. Eur Neuropsychopharmacol. 2006 Feb;16(2):107-13. doi: 10.1016/j.euroneuro.2005.07.005. Epub 2005 Oct 21. |
| 12767787 | Result | Giannoudis PV. Current concepts of the inflammatory response after major trauma: an update. Injury. 2003 Jun;34(6):397-404. doi: 10.1016/s0020-1383(02)00416-3. |
| 17717368 | Result | Leaver SK, Evans TW. Acute respiratory distress syndrome. BMJ. 2007 Aug 25;335(7616):389-94. doi: 10.1136/bmj.39293.624699.AD. No abstract available. |
| Result | Singer P, Cohen J: Indirect calorimetry and metabolic monitoring. In Fink M, Abraham E (eds), Textbook of Critical Care, Springer eds (Berlin), 2005 pp.] |
| Result | Gaynes RP, Horan TC. Surveillance of Nosocomial Infections.In: Mayhall CG, editor. Hospital Epidemiology and Infection Control. Philadelphia: Lippincott Williams & Wilkins,1285-1317,1999 |
| 38767196 | Derived | Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for prevention of post-traumatic stress disorder (PTSD) in individuals experiencing acute traumatic stress symptoms. Cochrane Database Syst Rev. 2024 May 20;5(5):CD013613. doi: 10.1002/14651858.CD013613.pub2. |
| 35141873 | Derived | Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for universal prevention of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2022 Feb 10;2(2):CD013443. doi: 10.1002/14651858.CD013443.pub2. |
| D008722 | Methods |