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Modulation of Systemic Inflammatory Response in Critically Ill Children After Glutamine Supplementation

NCT01367223 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2013-09-06

No results posted yet for this study

Summary

This study aims to describe the use of glutamine supplementation in the modulation of inflammatory response in critically ill pediatric patients and to determine if this decrease leads to clinical improvement in morbidity and mortality in these patients. Thus, these patients' diet could be supplemented with glutamine in order to improve their evolution.

Hypothesis:

From the data obtained in the study of the literature the investigators consider that:

Critically ill patients have a deficit of glutamine either because of an increase in its consumption or a decrease in its availability, and therefore blood glutamine levels are low.

Critically ill patients have elevated blood levels of pro-inflammatory substances (IL-6).

In these patients tissue lesion inhibitors (HSP-70) in the blood are decreased. The administration of glutamine supplements to these patients decreases oxidative stress due to the increase in HSP-70.

Inflammation inhibitory substances (IL-10) in the blood are decreased in these patients.

The administration of glutamine supplements in these patients increase IL-10 levels.

Glutamine supplements decrease the inflammatory response with a decrease in IL-6 levels.

Conditions

  • Inflammatory Response
  • Multi-organ Failure

Interventions

DIETARY_SUPPLEMENT

solution of amino acids supplemented with glutamine

parenteral nutrition by range of ages (recommendation from ESPGHAN and ESPEN:1 month to 3 years, 3 to 5 years, 6 to 12 and standard adult).Study Parenteral nutrition will be assessed the first 5 days.

DIETARY_SUPPLEMENT

amino acids not supplemented with glutamine

parenteral nutrition by range of ages (recommendation from ESPGHAN and ESPEN:1 month to 3 years, 3 to 5 years, 6 to 12 and standard adult).Study Parenteral nutrition will be assessed the first 5 days.

Sponsors & Collaborators

  • Fundació Sant Joan de Déu

    collaborator OTHER

  • Spanish National Health System

    collaborator OTHER

  • Hospital Sant Joan de Deu

    lead OTHER

Principal Investigators

  • Iolanda Jordan, PhMD · Hospital Sant Joan de Deu

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2012-07-31
Completion
2013-05-31

Countries

  • Spain

Study Locations

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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 NCT01367223 on ClinicalTrials.gov