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

Severe Sepsis Clinical Trial

— DHA-IRCO  

Official title:

Efecto Modulador de la Administracion Del Acido Docosahexaenoico Sobre la Respuesta Inflamatoria, la evolución Clinica y el Estado Nutricional de Neonatos Sometidos a cirugía

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01049529
• Other study ID #: 2005/3603/72
• Secondary ID: 2005/1/I/193
• Status: Completed
• Phase: Phase 2
• First received: January 13, 2010
• Last updated: January 12, 2017
• Start date: March 2007
• Est. completion date: September 2012

Study information

• Verified date: January 2017
• Source: Coordinación de Investigación en Salud, Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: September 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 45 Days

Eligibility

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

Related Conditions & MeSH terms

• Organ Dysfunction Syndrome
• Sepsis
• Severe Sepsis

Intervention

Dietary Supplement:
• Docosahexaenoic acid
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
• Placebo
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

Locations

Country	Name	City	State
Mexico	Unit of Research in Nutrition, Pediatric Hospital, Instituto Mexicano del Seguro Social	Mexico	Distrito Federal

Sponsors (1)

Lead Sponsor	Collaborator
Coordinación de Investigación en Salud, Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (4)

Bernabe-Garcia M, López-Alarcon M, Salgado-Sosa A, Villegas-Silva R, Maldonado-Hernandez J, Rodríguez-Cruz M, Rivas-Ruiz R, Chavez-Sanchez L, Blanco-Favela FA, Mancilla-Ramirez J, Gordillo-Alvarez V, Madrigal-Muñiz O. Enteral Docosahexaenoic Acid Reduces — View Citation

Bernabe-Garcia M, Lopez-Alarcon M, Villegas-Silva R, Mancilla-Ramirez J, Rodriguez-Cruz M, Maldonado-Hernandez J, Chavez-Rueda KA, Blanco-Favela F, Espinoza-Garcia L, Lagunes-Salazar S. Beneficial Effects of Enteral Docosahexaenoic Acid on the Markers of — View Citation

López-Alarcón M, Bernabe-García M, Del Prado M, Rivera D, Ruiz G, Maldonado J, Villegas R. Docosahexaenoic acid administered in the acute phase protects the nutritional status of septic neonates. Nutrition. 2006 Jul-Aug;22(7-8):731-7. — View Citation

López-Alarcón M, Bernabe-García M, del Valle O, González-Moreno G, Martínez-Basilea A, Villegas R. Oral administration of docosahexaenoic acid attenuates interleukin-1ß response and clinical course of septic neonates. Nutrition. 2012 Apr;28(4):384-90. doi: 10.1016/j.nut.2011.07.016. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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