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NCT Number: NCT02231203

Effect of Omega-3 Fatty Acids on the Perioperative Immune Response and Erythrocyte Function

Ideally, the postoperative inflammatory response is part of a well-orchestrated mechanism that contributes to tissue healing and rapid recovery. An exaggerated uncontrolled inflammatory response, however may lead to catabolism, tissue damage and organ failure. Omega-3 fatty acids may provide a means to alter cellular immune responses to the benefit of the patient. When omega-3 fatty acids are incorporated into membranes of inflammatory cells, they trigger intracellular signalling pathways that result in a less pro-inflammatory response. They modify gene and protein expression, modulate membrane protein activity and act as a reservoir for bioactive molecules. They also have a strong anti-inflammatory effect by mediating resolution of the inflammation. Furthermore, omega-3 fatty acids improve erythrocyte function, which is vital for an adequate microcirculation, tissue oxygenation and wound healing.

The investigators hypothesize that the perioperative administration of intravenous omega-3 fatty acids results in a rapid incorporation in immune cells and erythrocytes, thereby reducing the postoperative inflammatory response and improving erythrocyte function in patients undergoing colorectal surgery.

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Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical Center of Alkmaar

Alkmaar, North Holland, Netherlands

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients (male or female) undergoing elective laparoscopic surgery for colon cancer
  • Age between 60 and 80 years
  • BMI between 20 kg/m2 and below 30 kg/m2
  • Written informed consent

Exclusion criteria

  • Participation in or having participated in another clinical trial within the previous 3 months
  • Indications for continuously use of anticoagulant medication and no possibility to stop these medication perioperatively, for example patients with an artificial heart valve
  • Pre-operative Hemoglobin<5.0 mmol/L
  • Metastatic disease
  • Very poor peripheral venous access
  • Current history of inflammatory or infectious disease
  • The use of anti-inflammatory drugs
  • The use of thyroid medication
  • The use of fish oil products or fish consumption more than 2 times a week
  • Contra-indication for the use of Omegaven-Fresenius, including:
  • General contra-indications for parenteral nutrition
  • Allergy to fish or egg protein.

Treatment and study plan

Omegaven

Drug

2 infusions, 2 ml/kg, one the night before operation and one the day after operation

Other names: purified fish oil, omega-3 fatty acids, eicosapentaenoicacid (EPA), docosahexaenoicacid (DHA), dl-a- tocopherol (antioxidant), Omegaven-Fresenius

Placebo

Drug

2 infusions, 2 ml/kg, one the night before operation and one the day after operation

Other names: NaCl 0,9%, Natriumchloride 0,9%, glass container NaCl 0,9% Fresenius Kabi

Primary outcomes

  1. Change in ex vivo production of pro-inflammatory cytokine IL-6 in LPS stimulated whole blood

    Time frame: baseline, day of surgery, postoperative day 1,2 and 4

    Ex vivo stimulation of whole blood with LPS (lipopolysaccharide, component of gram negative bacteria) resulting in the production of the pro-inflammatory cytokine IL-6, measured in ng/ml.

Secondary outcomes

  1. Change in ex vivo production of TNF-α and IL-10 in LPS stimulated whole blood

    Time frame: baseline, day of surgery, postoperative day 1, 2 and 4

    Ex vivo stimulation of whole blood with LPS (lipopolysaccharide, component of gram negative bacteria) resulting in the production of the pro-inflammatory cytokine TNF-α (tumor necrosis factor-α), and the anti-inflammatory cytokine IL-10 (interleukine-10), both measured in ng/ml.

  2. Change in erythrocyte function

    Time frame: baseline, day of surgery, postoperative day 1, 2 and 4

    Erythrocyte deformability and aggregation measured by LORRCA (laser assisted optical rotational red cell analyzer)

  3. Change in in vivo systemic inflammatory response parameters

    Time frame: baseline, day of surgery, postoperative day 1, 2 and 4

    White blood cell count, C-reactive protein and cytokine levels (Interleukine-6, Tumor Necrosis Factor-α and Interleukine-10) in serum.

Other outcomes

  1. Postoperative outcome (composite measure of length of stay and complications)

    Time frame: Registration during admission, follow up 2 and 4 weeks after surgery

    Length of hospital stay and occurence of surgical site infection, abscess, urinary tract infection, pneumonia, anastomotic leakage, need for Intensive Care Unit admission, Systemic Inflammatory Response Syndrome, Multi Organ Failure, any adverse events.

  2. Cognitive function

    Time frame: baseline, follow up 2 weeks after surgery

    Neuropsychological examination using a reading test, an auditory verbal learning test, WAIS III figure series and trail making tests.

Sponsors and collaborators

Lead sponsor

Medical Center Alkmaar

Other

Registry information

Official study title

Effect of Intravenous Omega-3 Fatty Acids on the Perioperative Immune Response and Erythrocyte Function in Patients With Colon Cancer

Acronym: EMPIRE

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 4, 2014
Registry last updated
Jul 31, 2018

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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