NCT03166449

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2015

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

May 22, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 25, 2017

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

1.1 years

First QC Date

May 22, 2017

Last Update Submit

May 24, 2017

Conditions

Traumatic Brain InjuryImmuno-DeficiencyNutrient Deficiency

Keywords

Traumatic Brain injuryImmunonutrition

Outcome Measures

Primary Outcomes (3)

  • Levels of biomarkers

    Venous blood was withdrawn from patients to check levels of interleukin-6 (IL-6), glutathione, C-reactive protein (CRP)

    Day 1 of enteral nutrition

  • Levels of biomarkers

    Venous blood was withdrawn from patients to check levels of interleukin-6 (IL-6), glutathione, C-reactive protein (CRP)

    Day 5 of enteral nutirtion

  • Levels of biomarkers

    Venous blood was withdrawn from patients to check levels of interleukin-6 (IL-6), glutathione, C-reactive protein (CRP)

    Day 7 of enteral nutirtion

Secondary Outcomes (1)

  • Levels of total protein and albumin

    Day 1, 5 and 7 of enteral nutrition

Study Arms (2)

Neomune

EXPERIMENTAL

18 patients with traumatic brain injury were given Neomune as enteral nutrition.

Dietary Supplement: Neomune

Fresubin® HP energy

ACTIVE COMPARATOR

18 patients with traumatic brain injury were given Fresubin® HP energy as enteral nutrition.

Dietary Supplement: Fresubin® HP energy

Interventions

NeomuneDIETARY_SUPPLEMENT

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

Neomune
Fresubin® HP energyDIETARY_SUPPLEMENT

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

Fresubin® HP energy

Eligibility Criteria

Age15 Years - 78 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Admission within 48 hours of post traumatic event
  • Moderate to severe head injury (Glasgow Coma Scale 3-12)
  • Requires enteral nutrition.

You may not qualify if:

  • Uncontrolled diabetes mellitus
  • Renal or liver dysfunction
  • Severe sepsis with multi organ failure
  • History of significant abdominal or chest injuries requiring major surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anaesthesia Department, Faculty of Medicine, University Malaya

Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

Location

Related Publications (2)

  • 1. MOH: National trauma database January 2009 to December 2009 fourth report. 2011. 2. Health Facts 2015 [http://vlib.moh. gov.my/cms/ documentstorage/ com.tms.cms. document.Document_ef876440-a0188549-82a26f00 e6a36876/ KKM_ HEALTH _ FACTS _ 2015.pdf] 3. Hyder AA, Wunderlich CA, Puvanachandra P, Gururaj G, Kobusingye OC: The impact of traumatic brain injuries: a global perspective. NeuroRehabilitation. 2007; 22(5):341-353. 4. MOH: Malaysian registry of intensive care report for 2013. Malaysian Registry of Intensive Care, Clinical Research Centre, Ministry of Health Malaysia; 2013. 5. Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS medicine. 2006;3(11):e442. 6. Bullock MR, Povlishock JT: Guidelines for the management of severe traumatic brain injury. Editor's Commentary. J Neurotrauma. 2007;24 Suppl 1:2 p preceding S1. 7. Harris JA, Benedict FG. A biometric study of human basal metabolism. Proc. Natl. Acad. Sci. 1918;4(12):370-373. 8. Roza AM, Shizgal HM. The Harris Benedict equation reevaluated: resting energy requirements and the body cell mass. Am J Clin Nutr. 1984;40(1):168-182. 9. Painter TJ, Rickerds J, Alban RF. Immune enhancing nutrition in traumatic brain injury-A preliminary study Int J Surg. 2015 Sep 30;21:70-4.

    RESULT

  • Rai VRH, Phang LF, Sia SF, Amir A, Veerakumaran JS, Kassim MKA, Othman R, Tah PC, Loh PS, Jailani MIO, Ong G. Effects of immunonutrition on biomarkers in traumatic brain injury patients in Malaysia: a prospective randomized controlled trial. BMC Anesthesiol. 2017 Jun 15;17(1):81. doi: 10.1186/s12871-017-0369-4.

    PMID: 28619005DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Vineya Rai Hakumat Rai

    University of Malaya

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Anesthesiologist

Study Record Dates

First Submitted

May 22, 2017

First Posted

May 25, 2017

Study Start

July 1, 2014

Primary Completion

July 31, 2015

Study Completion

July 31, 2015

Last Updated

May 30, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)