NCT01099501

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2010

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2010

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 7, 2010

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

November 25, 2013

Status Verified

October 1, 2013

Enrollment Period

4.1 years

First QC Date

April 1, 2010

Last Update Submit

November 21, 2013

Conditions

Multiple TraumaHead Trauma

Keywords

Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

  • Oxygenation (PO2/FIO2 ratio)

    PO2/FIO2 ratio; assessed by measuring arterial blood gases (AVL Omni Technology, Graz, Austria) and ventilator settings (10)

    2 years

Secondary Outcomes (2)

  • TNF-α, CRP (markers of inflammatory response)

    2 years

  • Fatty acid composition of RBC phospholipids, including n-3:n-6 ratio (markers of n-3 PUFA incorporation into blood cell membranes)

    2 years

Study Arms (2)

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.

Dietary Supplement: Oxepa (enteral nutrition formula, ABBOTT), at a dose determined by a patient's energy expenditure and tolerance of enteral feeding.Dietary Supplement: oxepa

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.

Dietary Supplement: Control group

Interventions

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

Oxepa
oxepaDIETARY_SUPPLEMENT

A dose determined by a patient's energy expenditure and tolerance of enteral feeding.

Oxepa
Control groupDIETARY_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.

Control group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females aged 18-90 years with multiple-trauma or head trauma admitted to the ICU.
  • Enteral nutrition can be initiated within 36 hours of admission/ injury.
  • Mechanical ventilation.

You may not qualify if:

  • Severe underlying systemic disease and /or treatment with immunosuppressive agents.
  • Contra-indication for Enteral Nutrition (mechanical or functional bowel. obstruction, high-output fistula, severe necrotizing pancreatitis).
  • nd /3rd degree burns covering \> 66% BSA.
  • Pregnancy.
  • Participants under the age of 18.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical Center, Campus Beilinson

Petah Tikva, 49100, Israel

RECRUITING

Related Publications (15)

  • 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.

    PMID: 15659944BACKGROUND

  • 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.

    PMID: 7509706BACKGROUND

  • 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.

    PMID: 2501509BACKGROUND

  • 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.

    PMID: 1616387BACKGROUND

  • 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.

    PMID: 8857857BACKGROUND

  • 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.

    PMID: 7932892BACKGROUND

  • 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.

    PMID: 19005311BACKGROUND

  • 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.

    PMID: 16484911BACKGROUND

  • 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.

    PMID: 16243493BACKGROUND

  • 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.

    PMID: 12767787RESULT

  • 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.

    PMID: 17717368RESULT

  • 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

    RESULT

  • 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.

    PMID: 38767196DERIVED

  • 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.

    PMID: 35141873DERIVED

MeSH Terms

Conditions

Multiple TraumaCraniocerebral Trauma

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Wounds and InjuriesTrauma, Nervous SystemNervous System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Pierre Singer, MD, Professor

    Rabin Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre Singer, Principal Investigator MD

CONTACT

972-3-9376521psinger@clalit.org.il

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD

Study Record Dates

First Submitted

April 1, 2010

First Posted

April 7, 2010

Study Start

April 1, 2010

Primary Completion

May 1, 2014

Study Completion

August 1, 2014

Last Updated

November 25, 2013

Record last verified: 2013-10

Locations

IL(1)