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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Oswaldo Cruz Foundation.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Oswaldo Cruz Foundation
ClinicalTrials.gov Identifier:
NCT00792883
First received: November 17, 2008
Last updated: July 21, 2011
Last verified: July 2011
  Purpose

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
Electric Impedance
Metabolic Expenditure and Respiratory Function.
Polymorphisms Determinations of the Genes for TNF-alfa(-863 e -308), IL-1ra, LTalfa, IL-6, MIF e IL10.
Cytokines Measurement
NF-kappa B Activation.

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Protocol Validation to Identify Prognostic Markers for Critical Care Pediatric Patients

Resource links provided by NLM:


Further study details as provided by Oswaldo Cruz Foundation:

Primary Outcome Measures:
  • mortality [ Time Frame: two years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • morbidity [ Time Frame: two years ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

DNA extracts from blood or oral swab


Estimated Enrollment: 1000
Study Start Date: October 2007
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
A
142 Patients in respiratory failure with a diagnosis of ARDS hospitalized at the ICU.
B
432 patients in respiratory failure from other causes (ARDS being formally excluded), hospitalized at the same ICU.
C
626 healthy patients undergoing elective surgery at the Pediatric Surgery Department or recruited from the pediatric ambulatory.

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.

  Eligibility

Ages Eligible for Study:   1 Month to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

children in intensive care unit

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00792883

Contacts
Contact: Zina Maria A Azevedo, Phd 021-25541873 zina@iff.fiocruz.br
Contact: Daniella B Moore, Phd 021-25541731 danimoore@iff.fiocruz.br

Locations
Brazil
Instituto Fernandes Figueira Recruiting
Rio de Janeiro, Brazil, 22250-020
Contact: Zina Maria A Azevedo, Phd    021-25541873    zina@iff.fiocruz.br   
Contact: Daniella B Moore, phd    021-25541731    danimoore@iff.fiocruz.br   
Principal Investigator: Zina Maria A Azevedo, MD PhD         
Sub-Investigator: Maria Ignez G Elsas, MD PhD         
Sub-Investigator: Pedro Paulo X Elsas, MD PhD         
Sub-Investigator: Milton O Moraes, PhD         
Sub-Investigator: Elisabeth Sampaio, MD PhD         
Sub-Investigator: Daniella B Moore, MD PhD         
Sub-Investigator: Zilton M Vasconcelos, PhD         
Sub-Investigator: Maria Virginia P Dutra, PhD         
Sub-Investigator: Eloane G Ramos, PhD         
Sub-Investigator: Vania M Mattos, PhD         
Sub-Investigator: Marcia C Castro, Msc         
Sub-Investigator: Luis Fernando P Amêndola, Msc         
Sub-Investigator: Daniela M Caixeta, M.D.         
Sponsors and Collaborators
Oswaldo Cruz Foundation
Investigators
Principal Investigator: Zina Maria A de Azevedo Fernandes Figueira Institute - Fiocruz
Study Chair: Daniella B Moore Fernandes Figueira Institute - Fiocruz
  More Information

Additional Information:
No publications provided by Oswaldo Cruz Foundation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Zina Maria Almeida de Azevedo. MD. Phd- Physician in Chief Pediatric Critical Care Unit (UPG), Oswaldo Cruz Foundation
ClinicalTrials.gov Identifier: NCT00792883     History of Changes
Other Study ID Numbers: CONEP: 7378
Study First Received: November 17, 2008
Last Updated: July 21, 2011
Health Authority: Brazil: Ethics Committee

Keywords provided by Oswaldo Cruz Foundation:
PICU
BIA
Phase angle
RQ
EEM
Compliance
Resistance
Curves
Polymorphisms
NF-kappa B
Scores
PIM 2
PRISM I

ClinicalTrials.gov processed this record on October 20, 2014