Effect of Docosahexaenoic Acid on the Inflammatory Response and Clinical Outcomes From Surgical Patients

Phase 2

Completed

• Conditions: Organ Dysfunction Syndrome; Severe Sepsis
• Interventions: Dietary Supplement: Docosahexaenoic acid; Dietary Supplement: Placebo

• Registration Number: NCT01049529
• Lead Sponsor: Coordinación de Investigación en Salud, Mexico

Brief Summary

The purpose of this study is to evaluate if enteral docosahexaenoic acid (DHA) administration attenuates the inflammatory cytokines and improve clinical outcomes in neonates who underwent cardiovascular surgery

Detailed Description

Severe sepsis and organ failure are leading causes of death in surgical patients. Several studies indicate that a causal relationship exists between the surgical or traumatic injury and the predisposition to develop septic/infectious complications and multiple organ failure; this is attributable to uncontrolled inflammatory response. Since neonates have an immature immune system, they are in a higher risk to develop uncontrolled inflammatory response and adverse clinical outcomes.

N-3 long chain polyunsaturated fatty acids (L-PUFAs) such as docosapentaenoic and docosahexaenoic acids (EPA and DHA) have been shown to reduce the inflammatory response by reducing cytokines, infection rates and length of hospitalization in patients with abdominal surgery. Therefore, acute and enteral administration of DHA may improve clinical outcomes in neonates with cardiovascular surgery

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2010-01-13
• Study First Submitted QC: 2010-01-13
• Study First Posted: 2010-01-14
• Primary Completion: 2011-06
• Study Completion: 2012-09
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-12
• Last Update Posted: 2017-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• Authorization from both parents for recruiting of the neonate into the study with consent signed form after the purpose and procedures have been explained
• Gestational age older than 32 weeks
• Adequate weight for gestational age
• Gastrointestinal tract that allows tolerate the doses of DHA or placebo
• No signs of Systemic Inflammatory Response Syndrome before the surgery as fever >38 degrees C or hypothermia <36 degrees C, or leukocytosis >19,500 cells/cubic mm or < 5000 cells/cubic mm or > 10% immature forms.

Exclusion Criteria

• Fasting for more than two days after surgery
• Discharge to other hospital outside the metropolitan area
• Parents who decide to decline of the study
• Patients who necessitate cardiovascular bypass

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DHA group	Docosahexaenoic acid	This group is receiving the docosahexaenoic acid (DHA) supplement
Placebo group	Placebo	This group is receiving sunflower oil (the excipient for DHA)

Primary Outcome Measures

Name	Time	Method
Inflammatory response measured by cytokines IL-1, IL-6, TNF-alfa, IL-10 e IL-1ra and clinical outcomes assessed as frequency of severe sepsis, respiratory and cardiovascular dysfunction.	During the hospital stay, two weeks in average

Trial Locations

Locations (1)

Unit of Research in Nutrition, Pediatric Hospital, Instituto Mexicano del Seguro Social; 🇲🇽 Mexico, Distrito Federal, Mexico