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

Effect of EPA, GLA and Antioxidants on the Immune Response - Cellular and Molecular Mechanisms of Wound Healing in Critically Ill Patients.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00487097

Enrollment

Registered

2007-06-15

Start date

2007-09-30

Completion date

2010-05-31

Last updated

2013-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intensive Care, Pressure Sores

Keywords

intensive care, critically ill, fish oil, pressure sores

Brief 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.

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.

Interventions

DIETARY_SUPPLEMENTEicosapentanoic acid, docosahexaenoic acid

Enteral nutrition formula enriched with Eicosapentanoic acid, docosahexaenoic acid

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Improvement of wound healing of pressure sores	within 28 days

Secondary

Measure	Time frame
Improvement in parameters of immunity and inflammation	Within 28 days

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026