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

January 12, 2017 updated by: Mariela Bernabe García, Coordinación de Investigación en Salud, Mexico

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Distrito Federal
      • Mexico, Distrito Federal, Mexico, 06720
        • Unit of research in Nutrition, Pediatric Hospital, Instituto Mexicano del Seguro Social

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 month (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo group
This group is receiving sunflower oil (the excipient for DHA)
Dietary supplement: 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
Other Names:
  • Life's DHA
Active Comparator: DHA group
This group is receiving the docosahexaenoic acid (DHA) supplement
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
Other Names:
  • omega 3 fatty acids
  • n-3 LC-PUFAs
  • Long chain polyunsaturated fatty acids

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
During the hospital stay, two weeks in average

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coordinación de Investigación en Salud, Mexico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

January 13, 2010

First Submitted That Met QC Criteria

January 13, 2010

First Posted (Estimate)

January 14, 2010

Study Record Updates

Last Update Posted (Estimate)

January 13, 2017

Last Update Submitted That Met QC Criteria

January 12, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005/3603/72
  • 2005/1/I/193 (Other Grant/Funding Number: Fondo para la Investigación en Salud, IMSS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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