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

NCT01049529 | Completed Phase 2 DMC

• 2 other identifiers: 2005/3603/722005/1/I/193
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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

Conditions

Severe Sepsis; Organ Dysfunction Syndrome

Keywords

Docosahexaenoic acid; n-3 Long Chain Polyunsaturated Fatty Acids; omega 3 fatty acids; neonates; clinical outcomes; critically ill patients; Inflammatory and antiinflammatory cytokines; Length of intensive care stay

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

DHA group

ACTIVE COMPARATOR

This group is receiving the docosahexaenoic acid (DHA) supplement

Dietary Supplement: Docosahexaenoic acid

Interventions

Docosahexaenoic acid DIETARY_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

Also known as: n-3 LC-PUFAs, omega 3 fatty acids, Long chain polyunsaturated fatty acids

DHA group

Placebo DIETARY_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

Also known as: Life's DHA

Placebo group

Eligibility Criteria

• Age: 1 Day - 45 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead

Study Sites (1)

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

Mexico City, Mexico City, 06720, Mexico

Location

Related Publications (4)

• Lopez-Alarcon M, Bernabe-Garcia 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. doi: 10.1016/j.nut.2006.04.002. Epub 2006 Jun 5.

  PMID: 16750345 BACKGROUND

• Lopez-Alarcon M, Bernabe-Garcia M, del Valle O, Gonzalez-Moreno G, Martinez-Basilea A, Villegas R. Oral administration of docosahexaenoic acid attenuates interleukin-1beta response and clinical course of septic neonates. Nutrition. 2012 Apr;28(4):384-90. doi: 10.1016/j.nut.2011.07.016. Epub 2011 Nov 12.

  PMID: 22079797 BACKGROUND

• 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 Inflammation and Clinical Outcomes of Neonates Undergoing Cardiovascular Surgery: An Intervention Study. Ann Nutr Metab. 2016;69(1):15-23. doi: 10.1159/000447498. Epub 2016 Jul 9.

  PMID: 27394149 RESULT

• Bernabe-Garcia M, Lopez-Alarcon M, Salgado-Sosa A, Villegas-Silva R, Maldonado-Hernandez J, Rodriguez-Cruz M, Rivas-Ruiz R, Chavez-Sanchez L, Blanco-Favela FA, Mancilla-Ramirez J, Gordillo-Alvarez V, Madrigal-Muniz O. Enteral Docosahexaenoic Acid Reduces Analgesic Administration in Neonates Undergoing Cardiovascular Surgery. Ann Nutr Metab. 2016;69(2):150-160. doi: 10.1159/000452227. Epub 2016 Nov 2.

  PMID: 27806350 RESULT

MeSH Terms

Conditions

Sepsis

Interventions

Docosahexaenoic Acids; Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Mariela Bernabe-Garcia, PhD

  Instituto Mexicano del Seguro Social

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: January 13, 2010
• First Posted: January 14, 2010
• Study Start: March 1, 2007
• Primary Completion: June 1, 2011
• Study Completion: September 1, 2012
• Last Updated: January 13, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)