The Effect of Antioxidants on the Immune Response and Wound Healing in Critically Ill Patients

NCT ID: NCT00487097

Last Updated: 2013-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2010-05-31

Brief Summary

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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

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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

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Pressure Sores Intensive Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Study Group

Enteral Nutrition with Omega 3 (Eicosapentanoic acid, docosahexaenoic acid)

Group Type EXPERIMENTAL

Eicosapentanoic acid, docosahexaenoic acid

Intervention Type DIETARY_SUPPLEMENT

Enteral nutrition formula enriched with Eicosapentanoic acid, docosahexaenoic acid

Control Group

Patients in control group will receive nutritional support composed of a standard formula

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Eicosapentanoic acid, docosahexaenoic acid

Enteral nutrition formula enriched with Eicosapentanoic acid, docosahexaenoic acid

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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OXEPA

Eligibility Criteria

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Inclusion Criteria

* Critically ill patients in intensive care unit
* Grade 2 pressure sores

Exclusion Criteria

* Immunosuppression with steroids or other agents
* Active bleeding
* Head trauma
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rabin Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Pierre singer

Professor, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pierre Singer

Role: PRINCIPAL_INVESTIGATOR

Rabin Medical Center, Beilison Hospital, Israel

Locations

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Rabin Medical center

Petah Tikva, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type DERIVED
PMID: 22751375 (View on PubMed)

Other Identifiers

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4428

Identifier Type: -

Identifier Source: org_study_id

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