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Effects of Immunonutrition on Biomarkers in Traumatic Brain Injury

NCT03166449 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2017-05-30

No results posted yet for this study

Summary

Background: Head injury is one of the top three diagnosis leading to intensive care unit (ICU) admission in Malaysia. There has been growing interest in using immunonutrition as a mode of modulating the inflammatory response to injury or infection with the aim of improving clinical outcome. The aim of the present study was to evaluate the effect of an immunonutrition on biomarkers (IL-6, glutathione, CRP, total protein and albumin) in traumatic brain injury patients.

Methods: Thirty six patients with head injury admitted to neurosurgical ICU in University Malaya Medical Centre were recruited for this study, over a 6-month period from July 2014 to January 2015. Patients were randomized to receive either an immunonutrition (Group A) or a standard (Group B) enteral feed. Levels of biomarkers were measured at day 1, 5 and 7 of enteral feeding.

Results: Patients in Group A showed significant reduction of IL-6 at day 5 (p\<0.001) with concurrent rise in glutathione levels (p= 0.049). Patients in Group A also demonstrated a significant increase of total protein level at the end of the study (day 7).

Conclusion: These findings indicate the potential of immunonutrition reducing cytokines and increasing antioxidant indices in patients with TBI. However, further studies incorporating patient outcomes are needed to determine its overall clinical benefits.

Conditions

Interventions

DIETARY_SUPPLEMENT

Neomune

Enteral feeding with Neomune was delivered within 24 to 48 h after admission or surgery according to Brain Trauma Foundation (BTF) Guidelines

DIETARY_SUPPLEMENT

Fresubin® HP energy

Enteral feeding with Neomune was delivered within 24 to 48 h after admission or surgery according to Brain Trauma Foundation (BTF) Guidelines

Sponsors & Collaborators

  • University of Malaya

    lead OTHER

Principal Investigators

  • Vineya Rai Hakumat Rai · University of Malaya

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
78 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-01
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • Malaysia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03166449 on ClinicalTrials.gov