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

Primary Purpose

Severe Sepsis, Organ Dysfunction Syndrome

Status
Completed
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Docosahexaenoic acid
Placebo
Sponsored by
Coordinación de Investigación en Salud, Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Severe Sepsis focused on measuring 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

Eligibility Criteria

1 Day - 45 Days (Child)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo group

DHA group

Arm Description

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

This group is receiving the docosahexaenoic acid (DHA) supplement

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 13, 2010
Last Updated
January 12, 2017
Sponsor
Coordinación de Investigación en Salud, Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT01049529
Brief Title
Effect of Docosahexaenoic Acid on the Inflammatory Response and Clinical Outcomes From Surgical Patients
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Coordinación de Investigación en Salud, Mexico

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
This group is receiving sunflower oil (the excipient for DHA)
Arm Title
DHA group
Arm Type
Active Comparator
Arm Description
This group is receiving the docosahexaenoic acid (DHA) supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Docosahexaenoic acid
Other Intervention Name(s)
n-3 LC-PUFAs, omega 3 fatty acids, Long chain polyunsaturated fatty acids
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Other Intervention Name(s)
Life's DHA
Intervention Description
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
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
45 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariela Bernabe-Garcia, PhD
Organizational Affiliation
Instituto Mexicano del Seguro Social
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unit of Research in Nutrition, Pediatric Hospital, Instituto Mexicano del Seguro Social
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
06720
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16750345
Citation
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.
Results Reference
background
PubMed Identifier
22079797
Citation
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.
Results Reference
background
PubMed Identifier
27394149
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 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.
Results Reference
result
PubMed Identifier
27806350
Citation
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.
Results Reference
result

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

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