Effect of Docosahexaenoic Acid on the Inflammatory Response and Clinical Outcomes From Surgical Patients (DHA-IRCO)

Coordinación de Investigación en Salud, Mexico

Status and phase: Completed; Phase 2

Conditions: Organ Dysfunction Syndrome; Severe Sepsis

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Docosahexaenoic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT01049529

2005/3603/72

2005/1/I/193 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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

Enrollment: 55 patients

Sex: All

Ages: 1 to 45 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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55 participants in 2 patient groups, including a placebo group

Placebo group

Placebo Comparator group

Description:

This group is receiving sunflower oil (the excipient for DHA)

Treatment:

Dietary Supplement: Placebo

DHA group

Active Comparator group

Description:

This group is receiving the docosahexaenoic acid (DHA) supplement

Treatment:

Dietary Supplement: Docosahexaenoic acid