Pressure SoresNCT00487097
The Effect of Antioxidants on the Immune Response and Wound Healing in Critically Ill Patients
A study testing Eicosapentanoic acid, docosahexaenoic acid in people with Pressure Sores and Intensive Care, run by Rabin Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to investigate whether the addition of omega-3 and antioxidants to nutritional support in critically ill patients in the intensive care unit influences the immune and anti-inflammatory systems and so improves wound healing. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pressure Sores, Intensive Care
- What is being tested?
- Eicosapentanoic acid, docosahexaenoic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2007to May 2010
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Critically ill patients in intensive care unit
- Grade 2 pressure sores
Who cannot join
- Immunosuppression with steroids or other agents
- Active bleeding
- Head trauma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of EPA, GLA and Antioxidants on the Immune Response - Cellular and Molecular Mechanisms of Wound Healing in Critically Ill Patients.
The purpose of this study is to investigate whether the addition of omega-3 and antioxidants to nutritional support in critically ill patients in the intensive care unit influences the immune and anti-inflammatory systems and so improves wound healing.
Read the detailed description
A prospective randomized study to include 40 consecutive patients admitted to the general intensive care unit. The control group will receive nutritional support composed of a standard formula. The study group will receive nutritional support enriched with fish oil and anti-oxidants. The following variables will be assessed in all patients: demographics, severity of illness, assessment of bed sores. Blood tests will also be taken for the following: CD 8, CD 14, CD 18, CD 11a, CD49c, CD 49d. In addition, blood samples will be collected for TNF, IL-1b, IL-6, IL-8, and levels of C-reactive protein. Metabolic parameters such as resting energy expenditure, BMI, albumin, prealbumin, levels of zinc, relationship between omega 3 and omega 6. Theses test will be performed at time of ICU admission, days 7, 14 and 28 after admission.
The outcome: improved repair of pressure sores, together with improvement in objective parameters of immunity and inflammation.
- Conditions
- Pressure Sores, Intensive Care
- Being tested
- Eicosapentanoic acid, docosahexaenoic acid
- Keywords
- intensive care, critically ill, fish oil, pressure sores
- Medical subject headings
- Pressure Ulcer, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eicosapentanoic acid, docosahexaenoic acidDietary supplement
Also called OXEPA
Enteral nutrition formula enriched with Eicosapentanoic acid, docosahexaenoic acid
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Enteral Nutrition with Omega 3 (Eicosapentanoic acid, docosahexaenoic acid) Receives: Dietary Supplement: Eicosapentanoic acid, docosahexaenoic acid |
| Control Group | No intervention | Patients in control group will receive nutritional support composed of a standard formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of wound healing of pressure sores
Measured: within 28 days
Secondary outcomes (1)
Improvement in parameters of immunity and inflammation
Measured: Within 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2007 (estimated)
- Study startSep 2007
- Primary completionMay 2010
- Study completionMay 2010
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 Pressure SoresStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pierre singer, Rabin Medical Center
- Investigators
- Pierre Singer, Principal investigator, Rabin Medical Center, Beilison Hospital, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00487097
- Sponsor's protocol ID
- 4428
- Status last verified
- Feb 2013
- First submitted
- 14 Jun 2007
- Last updated
- 18 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Theilla M, Schwartz B, Cohen J, Shapiro H, Anbar R, Singer P. Impact of a nutritional formula enriched in fish oil and micronutrients on pressure ulcers in critical care patients. Am J Crit Care. 2012 Jul;21(4):e102-9. doi: 10.4037/ajcc2012187.
PubMed 22751375
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of EPA, GLA and Antioxidants on the Immune Response - Cellular and Molecular Mechanisms of Wound Healing in Critically Ill Patients.
- ClinicalTrials.gov ID
- NCT00487097
- Acronym / sponsor ID
- 4428
- Conditions
- Pressure Sores, Intensive Care
- Keywords
- intensive care, critically ill, fish oil, pressure sores
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 15 Jun 2007 (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 purpose of this study is to investigate whether the addition of omega-3 and antioxidants to nutritional support in critically ill patients in the intensive care unit influences the immune and anti-inflammatory systems and so improves wound healing.
Detailed description
A prospective randomized study to include 40 consecutive patients admitted to the general intensive care unit. The control group will receive nutritional support composed of a standard formula. The study group will receive nutritional support enriched with fish oil and anti-oxidants. The following variables will be assessed in all patients: demographics, severity of illness, assessment of bed sores. Blood tests will also be taken for the following: CD 8, CD 14, CD 18, CD 11a, CD49c, CD 49d. In addition, blood samples will be collected for TNF, IL-1b, IL-6, IL-8, and levels of C-reactive protein. Metabolic parameters such as resting energy expenditure, BMI, albumin, prealbumin, levels of zinc, relationship between omega 3 and omega 6. Theses test will be performed at time of ICU admission, days 7, 14 and 28 after admission.
The outcome: improved repair of pressure sores, together with improvement in objective parameters of immunity and inflammation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Dietary Supplement: Eicosapentanoic acid, docosahexaenoic acidEnteral Nutrition with Omega 3 (Eicosapentanoic acid, docosahexaenoic acid) |
| Control Group | No intervention | –Patients in control group will receive nutritional support composed of a standard formula |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Critically ill patients in intensive care unit
- Grade 2 pressure sores
Key exclusion criteria (3 listed)
- Immunosuppression with steroids or other agents
- Active bleeding
- Head trauma
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 |
|---|---|---|
| Eicosapentanoic acid, docosahexaenoic acidAlso: OXEPAEnteral nutrition formula enriched with Eicosapentanoic acid, docosahexaenoic acid | Dietary supplement | Study Group |
Primary outcome
Improvement of wound healing of pressure sores
Time frame: within 28 days
1 secondary outcome
Improvement in parameters of immunity and inflammation
Time frame: Within 28 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 18 Feb 2013.
- Derived from this study: PubMed 22751375Theilla M, Schwartz B, Cohen J, Shapiro H, Anbar R, Singer P. Impact of a nutritional formula enriched in fish oil and micronutrients on pressure ulcers in critical care patients. Am J Crit Care. 2012 Jul;21(4):e102-9. doi: 10.4037/ajcc2012187.
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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 principal investigator
Rabin Medical Center, Beilison Hospital, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eicosapentanoic acid, docosahexaenoic acid in people with Pressure Sores and Intensive Care, 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 2 inclusion and 3 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 18 Feb 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.
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?
Improvement of wound healing of pressure sores (time frame: within 28 days). 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 NCT00487097, 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 18 Feb 2013.