Multiple TraumaPhase 4OMTNCT01099501
Oxepa in Multiple Trauma
A Phase 4 study testing Oxepa (enteral nutrition formula, ABBOTT), at a dose determined by a patient's energy expenditure and tolerance of enteral feeding. and oxepa in people with Multiple Trauma and Head Trauma, run by Rabin Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Multiple Trauma, Head Trauma
- What is being tested?
- Oxepa (enteral nutrition formula, ABBOTT), at a dose determined by a patient's energy expenditure and tolerance of enteral feeding. and oxepa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2010to Aug 2014
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
- 2nd /3rd degree burns covering > 66% BSA.
- Pregnancy.
- Participants under the age of 18.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rabin Medical Center, Campus Beilinson
Petah Tikva, 49100
Pierre Singer, MD, 972-39376521, psinger@clalit.org.il
Milana Grinev, Study Coordinator, 972-39376521, milang@clalit.org.il
About this study
Official title: Oxepa in Multiple Trauma: Prospective, Randomized, Comparative, Double-blind, Controlled Clinical Study
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.
Read the detailed description
Primary outcome:
Improvement in oxygenation
Secondary outcomes:
Significant improvement in other clinical and laboratory end points.
Primary endpoint:
Pulmonary function:
Oxygenation (PO2- FIO2 ratio)
- Incidence of ALI
- Length of Ventilation (LOV)
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:
- Length of ICU stay
- Length of hospitalization
- 28 day mortality
- Hospital 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:
- patients resume regular oral feeding
- day 28/ discharge from ICU/ exitus
- Patients transferred to Total Parenteral Nutrition Note: the attending physician according to the patient's needs will determine feeding of patients from there on.
Study termination (end of all study procedures):
- day 28/ discharge from ICU
- Patients transferred to Total Parenteral Nutrition before day 3 of the study
- Conditions
- Multiple Trauma, Head Trauma
- Being tested
- Oxepa (enteral nutrition formula, ABBOTT), at a dose determined by a patient's energy expenditure and tolerance of enteral feeding., oxepa, Control group
- Keywords
- Mechanical Ventilation
- Medical subject headings
- Multiple Trauma, Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
oxepaDietary supplement
A dose determined by a patient's energy expenditure and tolerance of enteral feeding.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenation (PO2/FIO2 ratio)
PO2/FIO2 ratio; assessed by measuring arterial blood gases (AVL Omni Technology, Graz, Austria) and ventilator settings (10)
Measured: 2 years
Secondary outcomes (2)
TNF-α, CRP (markers of inflammatory response)
Concentration of circulating inflammatory markers: TNF-α, CRP concentrations
Measured: 2 years
Fatty acid composition of RBC phospholipids, including n-3:n-6 ratio (markers of n-3 PUFA incorporation into blood cell membranes)
Fatty acid composition of RBC membrane (thin liquid chromatography)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionMay 2014 (estimated)
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Multiple TraumaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Israeli Ministry of Security
- Responsible party
- Principal investigator, Pierre singer, Rabin Medical Center
- Investigators
- Pierre Singer, MD, Professor, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01099501
- Sponsor's protocol ID
- PHMD- OT- 01
- Acronym
- OMT
- Status last verified
- Oct 2013
- First submitted
- 1 Apr 2010
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15659944Bernard 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.
PubMed 7509706Moore 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.
PubMed 2501509Kudsk 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.
PubMed 1616387Kudsk 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.
PubMed 8857857Moore 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.
PubMed 7932892Todd 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.
PubMed 19005311Singer 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.
PubMed 16484911Green 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.
PubMed 16243493Giannoudis 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.
PubMed 12767787Leaver 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.
PubMed 17717368Singer P, Cohen J: Indirect calorimetry and metabolic monitoring. In Fink M, Abraham E (eds), Textbook of Critical Care, Springer eds (Berlin), 2005 pp.]
Gaynes RP, Horan TC. Surveillance of Nosocomial Infections.In: Mayhall CG, editor. Hospital Epidemiology and Infection Control. Philadelphia: Lippincott Williams & Wilkins,1285-1317,1999
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.
PubMed 38767196Bertolini 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.
PubMed 35141873
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxepa in Multiple Trauma: Prospective, Randomized, Comparative, Double-blind, Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT01099501
- Acronym / sponsor ID
- OMT / PHMD- OT- 01
- Conditions
- Multiple Trauma, Head Trauma
- Keywords
- Mechanical Ventilation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- Israeli Ministry of Security
- Study start
- Apr 2010
- Primary completion
- May 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 7 Apr 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.
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.
Detailed description
Primary outcome:
Improvement in oxygenation
Secondary outcomes:
Significant improvement in other clinical and laboratory end points.
Primary endpoint:
Pulmonary function:
Oxygenation (PO2- FIO2 ratio)
- Incidence of ALI
- Length of Ventilation (LOV)
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:
- Length of ICU stay
- Length of hospitalization
- 28 day mortality
- Hospital 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:
- patients resume regular oral feeding
- day 28/ discharge from ICU/ exitus
- Patients transferred to Total Parenteral Nutrition Note: the attending physician according to the patient's needs will determine feeding of patients from there on.
Study termination (end of all study procedures):
- day 28/ discharge from ICU
- Patients transferred to Total Parenteral Nutrition before day 3 of the study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxepa | Active comparator | Dietary Supplement: Oxepa (enteral nutrition formula, ABBOTT), at a dose determined by a patient's energy expenditure and tolerance of enteral feeding., Dietary Supplement: oxepaOxepa (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 | Dietary Supplement: Control groupPulmocare or Jevity (enteral nutrition formula, ABBOTT)will be administered at a dose determined by a patient's energy expenditure and tolerance of enteral feeding. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
- 2nd /3rd degree burns covering > 66% BSA.
- Pregnancy.
- Participants under the age of 18.
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 |
|---|---|---|
| Oxepa (enteral nutrition formula, ABBOTT), at a dose determined by a patient's energy expenditure and tolerance of enteral feeding.Oxepa will be administered(enteral nutrition formula, ABBOTT), at a dose determined by a patient's energy expenditure and tolerance of enteral feeding | Dietary supplement | Oxepa |
| oxepaA dose determined by a patient's energy expenditure and tolerance of enteral feeding. | Dietary supplement | Oxepa |
| Control groupPulmocare 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 |
Primary outcome
Oxygenation (PO2/FIO2 ratio)
Time frame: 2 years
PO2/FIO2 ratio; assessed by measuring arterial blood gases (AVL Omni Technology, Graz, Austria) and ventilator settings (10)
2 secondary outcomes
TNF-α, CRP (markers of inflammatory response)
Time frame: 2 years
Fatty acid composition of RBC phospholipids, including n-3:n-6 ratio (markers of n-3 PUFA incorporation into blood cell membranes)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2013.
- Background: PubMed 15659944MacCallum NS, Evans TW. Epidemiology of acute lung injury. Curr Opin Crit Care. 2005 Feb;11(1):43-9. doi: 10.1097/00075198-200502000-00007.
- Background: PubMed 7509706Bernard 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.
- Background: PubMed 2501509Moore 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.
- Background: PubMed 1616387Kudsk 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.
- Background: PubMed 8857857Kudsk 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.
- Background: PubMed 7932892Moore 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.
- Background: PubMed 19005311Todd 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.
- Background: PubMed 16484911Singer 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.
- Background: PubMed 16243493Green 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.
- Results publication: PubMed 12767787Giannoudis 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.
- Results publication: PubMed 17717368Leaver 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.
- Results publicationSinger P, Cohen J: Indirect calorimetry and metabolic monitoring. In Fink M, Abraham E (eds), Textbook of Critical Care, Springer eds (Berlin), 2005 pp.]
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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, Professor principal investigator
Rabin Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxepa (enteral nutrition formula, ABBOTT), at a dose determined by a patient's energy expenditure and tolerance of enteral feeding. and oxepa in people with Multiple Trauma and Head Trauma, run by Rabin 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 5 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 25 Nov 2013. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre Singer, Principal Investigator MD (972-3-9376521, psinger@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygenation (PO2/FIO2 ratio) (time frame: 2 years). 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 NCT01099501, which also lists 15 linked publications.
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 25 Nov 2013.