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

Coordinación de Investigación en Salud, Mexico55 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Severe Sepsis Organ Dysfunction Syndrome

Interventions

Docosahexaenoic acidDIETARY_SUPPLEMENT

DHA have oil form. Each neonate is receiving 75 mg/kg/day of DHA in 188 uL/kg/day in two doses per day, since two days before surgery and over six days following cardiovascular surgery

PlaceboDIETARY_SUPPLEMENT

Placebo have oil form. Each neonate is receiving 188uL/kg/day of sunflower oil as placebo in two doses per day, since two days before surgery and over six days following cardiovascular surgery

Eligibility

Sex: ALLMin age: 1 DayMax age: 45 Days

Medical Language ↔ Plain English

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

Locations (1)

Unit of Research in Nutrition, Pediatric Hospital, Instituto Mexicano del Seguro Social

Mexico City, Mexico City, Mexico

Outcomes

Primary Outcomes

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.

Time frame: During the hospital stay, two weeks in average

Data from ClinicalTrials.gov

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