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Completed

NCT Number: NCT00487097

The Effect of Antioxidants on the Immune Response and 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.

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Key information

Conditions

Pressure Sores Critical Illness Disease Attributes Intensive Care Pathologic Processes Pathological Conditions, Signs and Symptoms Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rabin Medical center

Petah Tikva, 49100, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eicosapentanoic acid, docosahexaenoic acid

Dietary Supplement

Enteral nutrition formula enriched with Eicosapentanoic acid, docosahexaenoic acid

Other names: OXEPA

Primary outcomes

  1. Improvement of wound healing of pressure sores

    Time frame: within 28 days

Secondary outcomes

  1. Improvement in parameters of immunity and inflammation

    Time frame: Within 28 days

Sponsors and collaborators

Lead sponsor

Rabin Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jun 15, 2007
Registry last updated
Feb 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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