Clinical Protocol Validation to Identify Prognostic Markers for Critical Care Pediatric Patients (PCL07)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00792883
Recruitment Status : Completed
First Posted : November 18, 2008
Last Update Posted : October 28, 2015
Information provided by (Responsible Party):
Zina Maria Almeida de Azevedo, Oswaldo Cruz Foundation

Brief Summary:
The purpose of this study is to monitor the respiratory, metabolic and nutritional status of critically ill pediatric patients undergoing mechanical ventilation and to correlate the clinical and physiopathological findings with inflammatory activity measurements in order to identify prognostic biomarkers.

Condition or disease

Detailed Description:

Background: Acute Respiratory Distress Syndrome (ARDS) is a frequent cause of respiratory failure in the pediatric intensive care unit (ICU). Bedside respiratory and metabolic monitoring has reduced both morbidity and mortality of children with ARDS in the ICU, and allowed precise evaluation of the gravity of ARDS in individual patients. Recent advances indicate that some ARDS patients present specific, genetically determined profiles of cytokine production, but it is unclear how these relate to systemic inflammation and the gravity of ARDS. It is necessary to define the correlation between genotype, systemic inflammation and prognosis in this group of patients, ir order to define whether they should be targeted for more aggressive anti-inflammatory and immunomodulatory therapy.

Objectives: 1) To evaluate metabolic expenditure,bioelectrical impedance (BIA) and respiratory function in critically ill children undergoing mechanical ventilation. 2) To correlate the metabolic and respiratory parameters with duration of mechanical ventilation, weaning, nutritional status,Phase angle (PA) of BIA, PRISMI and PIM 2 scores in the same children.3) To determine the presence of polymorphisms in the genes for TNF-alfa (- 308 and -863), IL-1ra, IL-6, MIF, LTalfa, il-10 and CD14 in the same children. 4) To define functional parameters of systemic inflammation, including plasma levels of TNF-alfa, IL-1ra, IL-6 and translocation of NF-kappa B in the same children. 5) To correlate genomic and immunological data with PRISM I and PIM 2 scores, PA and mortality.

Methodology: 1) Study Design: A cohort of patients undergoing mechanical ventilation will be submitted to metabolic and respiratory monitoring, and to monitoring of systemic inflammation by measurement of plasma cytokines and NF-kB translocation in peripheral blood leukocytes; a cross-sectional study of cytokine gene polymorphisms will be carried out int hte same population. 2)Subjects: 1000 children, aged 1 mo to 17 yr. Group A: 200 children with ARDS; Group B: 400 children with respiratory failure unrelated to ARDS; Group C (controls): 400 children undergoing preoperatory exams at surgical ward for elective surgery. 3) Methods: Metabolic monitoring: determination of VCO2, VO2, RQ, EEM through indirect calorimetry. Bioelectrical impedance: determination of resistance, reactance and phase angle. Respiratory monitoring: determination of respiratory parameters through capnography, pulse oxymetry, and assessment of respiratory mechanics. Genomic analysis: restriction site mapping and allele-specific amplification by PCR. Immunological evaluation: measurement of plasma cytokines by luminex multiple essays and analysis of NF-kB activation.

Study Type : Observational
Actual Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Protocol Validation to Identify Prognostic Markers for Critical Care Pediatric Patients
Study Start Date : October 2007
Actual Primary Completion Date : December 2011
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Critical Care

patients ARDS
142 Patients in respiratory failure with a diagnosis of ARDS hospitalized at the ICU.
Patients non ARDS
432 patients in respiratory failure from other causes (ARDS being formally excluded), hospitalized at the same ICU.
Healthy controls
626 healthy patients undergoing elective surgery at the Pediatric Surgery Department or recruited from the pediatric ambulatory.

Primary Outcome Measures :
  1. mortality [ Time Frame: two years ]

Secondary Outcome Measures :
  1. morbidity [ Time Frame: two years ]

Biospecimen Retention:   Samples With DNA
DNA extracts from blood or oral swab

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Ages Eligible for Study:   1 Month to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
children in intensive care unit

Inclusion Criteria:

  • children aged 1 mo to 17yr undergoing mechanical ventilation in the intensive care unit

Exclusion Criteria:

  • chronic inflammatory diseases
  • exposure to steroids or other anti-inflammatory agents from anu cause during the month preceding hospitalization.
  • malignancies of the immune system (leukemia, lymphoma)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00792883

Instituto Fernandes Figueira
Rio de Janeiro, Brazil, 22250-020
Sponsors and Collaborators
Oswaldo Cruz Foundation
Principal Investigator: Zina Maria A de Azevedo Fernandes Figueira Institute - Fiocruz
Study Chair: Daniella B Moore Fernandes Figueira Institute - Fiocruz

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Zina Maria Almeida de Azevedo, PhD, Chief of the pediatric critical care unit of Fernandes Figueira Institute, Oswaldo Cruz Foundation Identifier: NCT00792883     History of Changes
Other Study ID Numbers: CONEP: 7378
First Posted: November 18, 2008    Key Record Dates
Last Update Posted: October 28, 2015
Last Verified: October 2015

Keywords provided by Zina Maria Almeida de Azevedo, Oswaldo Cruz Foundation:
Phase angle
NF-kappa B