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

NCT01367223 | Completed Phase 4

• 1 other identifier: UCIHSJD5
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

inflammatory response; parenteral nutrition; glutamine; amino acid; pediatric; intensive care; systemic infection; abdominal surgery; polytraumatised; mortality; mean stay in the intensive care unit; occurrence of infections

Outcome Measures

Primary Outcomes (1)

• The primary study endpoint is to determine if there are any differences in inflammatory response in patients supplemented with glutamine compared to those who receive a standard diet without a glutamine supplement.

  Laboratory measures: IL-6, IL-10, HSP-70

  baseline-day2-day5

Secondary Outcomes (1)

• As secondary endpoints the clinical response of the two groups of patients was assessed with respect to the occurrence of infections, multi-organ failure, mean stay in the unit and mortality.

  During 27 days

Study Arms (2)

solution of amino acids with glutamine

EXPERIMENTAL

Group 1 as the experimental group who will be administered a solution of amino acids supplemented with glutamine

Dietary Supplement: solution of amino acids supplemented with glutamine

amino acids solution without glutamine

OTHER

Group 2:control group will be administered a solution of amino acids (Aminoven Infant® or Vamin®) not supplemented with glutamine

Dietary Supplement: amino acids not supplemented with glutamine

Interventions

solution of amino acids supplemented with glutamine DIETARY_SUPPLEMENT

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.

Also known as: (Aminoven Infant® or Vamin®) with glutamine (Dipeptiven®)

solution of amino acids with glutamine

amino acids not supplemented with glutamine DIETARY_SUPPLEMENT

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.

Also known as: (Aminoven Infant® or Vamin®) with glutamine (Dipeptiven®)

amino acids solution without glutamine

Eligibility Criteria

• Age: 1 Month - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \. Patients aged between 1 month and 14 years who require parenteral nutrition according to the criteria of our unit and who comply with the following diagnoses:
• Local or systemic infection
• Post abdominal surgery
• Polytraumatised
• Parenteral nutrition indications:
• Intestinal resections
• Bowel obstruction or post-surgery
• Risk of intestinal ischaemia due to hypotension of hypoxaemia

You may not qualify if:

• Legal representative does not give consent.
• Patients with previous underlying diseases (renal impairment, hepatic impairment, inflammatory bowel disease, rheumatic diseases, metabolic diseases, immunocompromised).
• Mild liver impairment on admittance (hepatitis, colostasis).
• Post cardiac surgery with extracorporeal circulation.
• Patients referred from other hospitals with a clinical evolution of over 48 hours.
• Patients aged less than one month and over 14 years.

Sponsors & Collaborators

• Hospital Sant Joan de Deu: lead
• Fundació Sant Joan de Déu: collaborator
• Spanish National Health System: collaborator

Study Sites (1)

Hospital Sant Joan de Déu

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Related Publications (44)

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MeSH Terms

Conditions

Multiple Organ Failure; Hyperphagia; Toxemia

Interventions

Glutamine; amino-acid, glucose, and electrolyte solution; alanylglutamine

Condition Hierarchy (Ancestors)

Shock; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms; Infections

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Neutral

Study Officials

• Iolanda Jordan, PhMD

  Hospital Sant Joan de Deu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2011
• First Posted: June 7, 2011
• Study Start: April 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: May 1, 2013
• Last Updated: September 6, 2013

Record last verified: 2013-09

Locations

ES (1)