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

July 28, 2018 updated by: Alexander P.J. Houdijk, Medical Center Alkmaar

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Noord Holland
      • Alkmaar, Noord Holland, Netherlands
        • Medical Center of Alkmaar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
2 infusions of NaCl, 2 ml/kg, one the night before operation and one the day after operation.
Drug: Placebo
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
Active Comparator: Omegaven
2 infusions of 2ml/kg, one the night before surgery and one the day after surgery
Drug: Omegaven
2 infusions, 2 ml/kg, one the night before operation and one the day after operation
Other Names:
  • omega-3 fatty acids
  • purified fish oil
  • eicosapentaenoicacid (EPA)
  • docosahexaenoicacid (DHA)
  • dl-a- tocopherol (antioxidant)
  • Omegaven-Fresenius

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, day of surgery, postoperative day 1,2 and 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, day of surgery, postoperative day 1, 2 and 4
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)
baseline, day of surgery, postoperative day 1, 2 and 4
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.
baseline, day of surgery, postoperative day 1, 2 and 4

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Registration during admission, follow up 2 and 4 weeks after surgery
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.
baseline, follow up 2 weeks after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical Center Alkmaar

Investigators

  • Principal Investigator: A.P.J. Houdijk, Dr., Medical Center of Alkmaar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2014

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

July 29, 2014

First Submitted That Met QC Criteria

September 1, 2014

First Posted (Estimate)

September 4, 2014

Study Record Updates

Last Update Posted (Actual)

July 31, 2018

Last Update Submitted That Met QC Criteria

July 28, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL46230.029.13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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