CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 101 enrolled
Drug / intervention
solution of amino acids supplemented with glutamine +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01367223
NCT01367223Phase 4Completed
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Modulation of Systemic Inflammatory Response in Critically Ill Children After Glutamine Supplementation

Hospital Sant Joan de Deu·interventional·Posted Jun 7, 2011·Updated Sep 6, 2013

In Brief

A Phase 4 clinical trial evaluating solution of amino acids supplemented with glutamine and amino acids not supplemented with glutamine for Inflammatory Response and Multi-organ Failure. Completed, enrolled 101 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInflammatory Response, Multi-organ Failure
CountriesSpain
CollaboratorsFundació Sant Joan de Déu, Spanish National Health System

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 7, 2011
Enrollment StartApr 1, 2010
Primary CompletionJul 1, 2012
Study CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 15.1 years ago

Interventions

solution of amino acids supplemented with glutaminedietary

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.

amino acids not supplemented with glutaminedietary

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.