Effect of Omega-3 Fatty Acids on the Perioperative Immune Response and Erythrocyte Function
EMPIRE
Effect of Intravenous Omega-3 Fatty Acids on the Perioperative Immune Response and Erythrocyte Function in Patients With Colon Cancer
1 other identifier
interventional
44
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 29, 2014
CompletedFirst Posted
Study publicly available on registry
September 4, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedJuly 31, 2018
July 1, 2018
1.7 years
July 29, 2014
July 28, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in ex vivo production of pro-inflammatory cytokine IL-6 in LPS stimulated whole blood
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 Outcomes (3)
Change in ex vivo production of TNF-α and IL-10 in LPS stimulated whole blood
baseline, day of surgery, postoperative day 1, 2 and 4
Change in erythrocyte function
baseline, day of surgery, postoperative day 1, 2 and 4
Change in in vivo systemic inflammatory response parameters
baseline, day of surgery, postoperative day 1, 2 and 4
Other Outcomes (2)
Postoperative outcome (composite measure of length of stay and complications)
Registration during admission, follow up 2 and 4 weeks after surgery
Cognitive function
baseline, follow up 2 weeks after surgery
Study Arms (2)
Placebo
PLACEBO COMPARATOR2 infusions of NaCl, 2 ml/kg, one the night before operation and one the day after operation.
Omegaven
ACTIVE COMPARATOR2 infusions of 2ml/kg, one the night before surgery and one the day after surgery
Interventions
2 infusions, 2 ml/kg, one the night before operation and one the day after operation
2 infusions, 2 ml/kg, one the night before operation and one the day after operation
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical Center of Alkmaar
Alkmaar, North Holland, Netherlands
Related Publications (1)
Bakker N, van den Helder RS, Stoutjesdijk E, van Pelt J, Houdijk APJ. Effects of perioperative intravenous omega-3 fatty acids in colon cancer patients: a randomized, double-blind, placebo-controlled clinical trial. Am J Clin Nutr. 2020 Feb 1;111(2):385-395. doi: 10.1093/ajcn/nqz281.
PMID: 31826232DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
A.P.J. Houdijk, Dr.
Medical Center of Alkmaar
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
July 29, 2014
First Posted
September 4, 2014
Study Start
October 1, 2014
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
July 31, 2018
Record last verified: 2018-07