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Trial record 24 of 32 for:    Interleukin-10

Airway Inflammatory Response During Illness in Children With Respiratory Failure

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ClinicalTrials.gov Identifier: NCT02047877
Recruitment Status : Withdrawn (Study concept vacated due to sample collection issues)
First Posted : January 28, 2014
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
The purpose of this study has two major goals: 1) to measure the amount of two specific hormones interleukin (IL)-10 and interleukin (IL)-12p70 in mucous and blood; and 2) compare the hormone levels in two specific areas of the lung called the trachea (upper airway) and the bronchioles (lower airway). The hormones IL-10 and IL-12p70 are cytokines, special hormones cells use to communicate with each other during inflammation or infection. Cytokines can be measured in mucous and blood. The balance of one cytokine compared to another help doctors to understand how people respond differently to infection. Unfortunately, the amount of IL-10 and IL-12p70 is not known in children, especially children with a lung infection. In addition, we do not know if the balance of these cytokines differ in various regions of the lung. We believe the balance of IL-10 and IL-12p70 is similar whether measured in the upper or lower airways.

Condition or disease
Acute Respiratory Failure Acute Respiratory Infection Acute Respiratory Distress Syndrome

Detailed Description:

This study is designed to measure the concentration and describe the distribution of cytokine IL-10 and IL-12p70 in a previously healthy pediatric population suffering direct lung injury by an infectious etiology, not yet described in the literature.

In addition, this study seeks to determine whether tracheal aspirates (TA) obtained in early acute respiratory failure can be substituted for distal airway aspirates, obtained by non-bronchoscopic broncho-alevolar lavage (nb-BAL), for the purposes of investigating markers of inflammation. We will compare the ratio of IL-10 to IL-12p70 at each time point measured in tracheal secretion, bronchial secretion, and blood to assess for sample equivalence.

Finally, this study will affirm the safety profile for repeated nb-BAL, establish a protocol for respiratory sample collection and storage for future larger scale studies, and generate feasibility data regarding consent rate, estimates of data completion, and fraction of missing data for us to determine whether a future study involving the ratio of IL-10 to IL-12p70 can be used as a predictor of acute respiratory distress syndrome (ARDS) in this population.

The data generated by this study regarding safety, comparison of nb-BAL and TA, and cytokine concentrations will be used as preliminary data informing the design of a larger multicenter study testing the hypothesis that IL-10 and IL-12p70 levels in airway secretions can predict risk for ARDS in this population. This may be approached via application to the Pediatric Acute Lung Injury and Sepsis (PALISI) clinical research network group.


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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigation of Airway Inflammatory Response During an Acute Respiratory Illness in Pediatric Patients With Respiratory Failure
Estimated Study Start Date : July 2017
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019


Group/Cohort
Respiratory Illness
Previously healthy patients admitted with acute respiratory illness who are then intubated requiring mechanical ventilator support. Endotracheally intubated patients of age 37 weeks gestation through 17 years with an acute respiratory illness in the absence of existing cardiopulmonary disease, tracheostomy, or immunocompromised condition. Tracheal aspirates (TA), bronchial fluid (nb-BALF), and blood are collected within 48-hours following endotracheal intubation. All three samples are collected again at two additional time points following intubation: between days 3-4 and between days 5-7, so long as the patient remains endotracheally intubated.



Primary Outcome Measures :
  1. Mean log transformed IL-10:IL-12p70 ratio in tracheal secretion, bronchial secretion, and serum within 48-hours of mechanical ventilation [ Time Frame: Within 48 hours of mechanical ventilation ]
    Tracheal aspirates (TA), bronchial fluid (nb-BALF), and blood are collected within 48-hours following endotracheal intubation. All three samples are collected again at two additional time points following intubation: between days 3-4 and between days 5-7, so long as the patient remains endotracheally intubated. Three time points were chosen to show consistency in ratio of IL-10 to IL-12p70 between TA and nb-BALF throughout the first week of endotracheal intubation. If a patient is extubated before day 7 all sample collection will stop. No samples will be obtained after 7 days of intubation as we are focusing on the acute phase of lung injury only. An ELISA assay is performed to measure the concentration of IL-10 and IL-12p70 for ratio comparison.


Secondary Outcome Measures :
  1. Blood oxygenation saturation and hemodynamic changes following non-bronchoscopic BAL [ Time Frame: Baseline through 1-hour post procedure ]

    Pulse Oxygen Saturation (SpO2), heart rate (HR), blood pressure (BP), and cardiac rhythm are continuously monitored per clinical routine in intubated patients. These parameters will be recorded pre-procedure then monitored over the 1 hour post-procedure. Transient and inconsequential changes in these parameters are expected. The following changes will be considered adverse events and reported to data safety monitor (DSM):

    1. Persistent (>10 minute) decrease in SpO2 of more than 10% below pre-procedure baseline during the 1-hour post-procedure.
    2. Persistent (>10 minute) increase in HR of more than 30 beats per minute above pre-procedure baseline during the 1-hour post-procedure.
    3. Persistent (>10 minute) decrease in MAP of more than 15 mm Hg below pre-procedure baseline during the 1-hour post-procedure.

  2. Mean log transformed IL-10:IL-12p70 ratio in tracheal secretion, bronchial secretion, and serum between days 3-4 [ Time Frame: Days 3 to 4 of mechanical ventilation ]
    Tracheal aspirates (TA), bronchial fluid (nb-BALF), and blood are collected within 48-hours following endotracheal intubation. All three samples are collected again at two additional time points following intubation: between days 3-4 and between days 5-7, so long as the patient remains endotracheally intubated. Three time points were chosen to show consistency in ratio of IL-10 to IL-12p70 between TA and nb-BALF throughout the first week of endotracheal intubation. If a patient is extubated before day 7 all sample collection will stop. No samples will be obtained after 7 days of intubation as we are focusing on the acute phase of lung injury only. An ELISA assay is performed to measure the concentration of IL-10 and IL-12p70 for ratio comparison.

  3. Mean log transformed IL-10:IL-12p70 ratio in tracheal secretion, bronchial secretion, and serum between days 5-7 [ Time Frame: Days 5 to 7 of mechanical ventilation ]
    Tracheal aspirates (TA), bronchial fluid (nb-BALF), and blood are collected within 48-hours following endotracheal intubation. All three samples are collected again at two additional time points following intubation: between days 3-4 and between days 5-7, so long as the patient remains endotracheally intubated. Three time points were chosen to show consistency in ratio of IL-10 to IL-12p70 between TA and nb-BALF throughout the first week of endotracheal intubation. If a patient is extubated before day 7 all sample collection will stop. No samples will be obtained after 7 days of intubation as we are focusing on the acute phase of lung injury only. An ELISA assay is performed to measure the concentration of IL-10 and IL-12p70 for ratio comparison.


Other Outcome Measures:
  1. Fraction of screened patients enrolled, fraction of patients with complete sample collection, and fraction of patients with complete clinical data [ Time Frame: 1-Year from Initial Enrollment ]
    Estimate the feasibility of enrolling ARDS patient for a future larger trial designed to examine IL-10:IL-12p70 as a predictor of ARDS in pediatric patients. This study will generate pilot data regarding consent rate, estimates of data completion, and fraction of missing clinical data necessary for us to determine whether a future study involving the ratio of IL-10 to IL-12p70 can be used as a predictor of ARDS in this population.


Biospecimen Retention:   Samples With DNA
Will bank all remaining serum, tracheal secretion, and bronchial secretion de-identified for purposes of future unknown scientific studies designed at examining respiratory secretions in this defined pediatric population.


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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Previously healthy patients presenting to UNC with respiratory failure presumptively caused by a primary lung infection will be screened. Only those patients intubated within 48-hours of potential enrollment and between the ages of ≥37 weeks gestation and 17 years will be considered. For purposes of this study, acute respiratory illness is defined as having upper respiratory infection symptoms and/or lower respiratory tract infection. Patient should have fever (>38 oC) OR leukocytosis / leukopenia (>10,000 or <2,000) AND any of the following: tachypnea, hypoxia (saturation <97%), cough, congestion, rhinorrhea, abnormal lung exam findings, or infiltrate on chest x-ray.
Criteria

Inclusion Criteria:

  • Previously healthy
  • Age 37 weeks gestation through 17 years
  • Presumed respiratory infection
  • Intubated <48 hours

Exclusion Criteria:

  • Trauma, Drowning, Pancreatitis, or Sepsis not originating from a pulmonary infection.
  • Pre-existing chronic disease including:
  • congenital heart disease or acquired cardiomyopathy
  • pulmonary hypertension
  • restrictive lung disease
  • cystic fibrosis
  • asthma controlled with chronically inhaled steroids
  • Tracheostomy
  • Immunocompromised including chronic steroid use within last month
  • Oncological condition except conditions in active remission not requiring maintenance chemotherapy.
  • Intubated patient with an endotracheal tube <3.5 mm
  • Patients with persistent SpO2 <90% despite adequate ventilator support, or patients deemed too unstable to undergo mini-BAL by the clinical care team

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 ClinicalTrials.gov identifier (NCT number): NCT02047877


Locations
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United States, North Carolina
University of North Carolina Hospital at Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
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Principal Investigator: Daniel Lercher, MD University of North Carolina Hospital at Chapel Hill
Study Director: Benny Joyner, MD, MPH University of North Carolina, Chapel Hill
Study Chair: Benny L Joyner, Jr., MD, MPH University of North Carolina, Chapel Hill

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02047877     History of Changes
Other Study ID Numbers: 13-2784
First Posted: January 28, 2014    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017

Keywords provided by University of North Carolina, Chapel Hill:
Respiratory Secretions
Tracheal Secretions
Bronchial Secretions
NonBronchoscopic BAL
Interleukin 10
Interleukin 12p70

Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Acute Lung Injury
Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Infection