Acute Respiratory FailureNCT02047877
Airway Inflammatory Response During Illness in Children With Respiratory Failure
An observational study of Acute Respiratory Failure and Acute Respiratory Infection, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Acute Respiratory Failure, Acute Respiratory Infection, Acute Respiratory Distress Syndrome
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2017to Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Previously healthy
- Age 37 weeks gestation through 17 years
- Presumed respiratory infection
- Intubated <48 hours
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina Hospital at Chapel Hill
Chapel Hill, North Carolina, 27514
About this study
Official title: Investigation of Airway Inflammatory Response During an Acute Respiratory Illness in Pediatric Patients With Respiratory Failure
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.
Read the 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.
- Conditions
- Acute Respiratory Failure, Acute Respiratory Infection, Acute Respiratory Distress Syndrome
- Keywords
- Respiratory Secretions, Tracheal Secretions, Bronchial Secretions, NonBronchoscopic BAL, Interleukin 10, Interleukin 12p70
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean log transformed IL-10:IL-12p70 ratio in tracheal secretion, bronchial secretion, and serum 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.
Measured: Within 48 hours of mechanical ventilation
Secondary outcomes (3)
Blood oxygenation saturation and hemodynamic changes following non-bronchoscopic BAL
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):
- Persistent (>10 minute) decrease in SpO2 of more than 10% below pre-procedure baseline during the 1-hour post-procedure.
- Persistent (>10 minute) increase in HR of more than 30 beats per minute above pre-procedure baseline during the 1-hour post-procedure.
- Persistent (>10 minute) decrease in MAP of more than 15 mm Hg below pre-procedure baseline during the 1-hour post-procedure.
Measured: Baseline through 1-hour post procedure
Mean log transformed IL-10:IL-12p70 ratio in tracheal secretion, bronchial secretion, and serum between days 3-4
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.
Measured: Days 3 to 4 of mechanical ventilation
Mean log transformed IL-10:IL-12p70 ratio in tracheal secretion, bronchial secretion, and serum between days 5-7
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.
Measured: Days 5 to 7 of mechanical ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startJul 2017 (estimated)
- Primary completionAug 2019 (estimated)
- Study completionAug 2019 (estimated)
Why it stopped: Study concept vacated due to sample collection issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Lercher, MD, Principal investigator, University of North Carolina Hospital at Chapel HillBenny Joyner, MD, MPH, Study director, University of North Carolina, Chapel HillBenny L Joyner, Jr., MD, MPH, Study chair, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02047877
- Sponsor's protocol ID
- 13-2784
- Status last verified
- Nov 2017
- First submitted
- 25 Jan 2014
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Airway Inflammatory Response During an Acute Respiratory Illness in Pediatric Patients With Respiratory Failure
- ClinicalTrials.gov ID
- NCT02047877
- Acronym / sponsor ID
- 13-2784
- Conditions
- Acute Respiratory Failure, Acute Respiratory Infection, Acute Respiratory Distress Syndrome
- Keywords
- Respiratory Secretions, Tracheal Secretions, Bronchial Secretions, NonBronchoscopic BAL, Interleukin 10, Interleukin 12p70
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study concept vacated due to sample collection issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Jul 2017 (estimated)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 28 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- Previously healthy
- Age 37 weeks gestation through 17 years
- Presumed respiratory infection
- Intubated <48 hours
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Blood oxygenation saturation and hemodynamic changes following non-bronchoscopic BAL
Time frame: Baseline through 1-hour post procedure
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
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Lercher, MD principal investigator
University of North Carolina Hospital at Chapel Hill
Benny Joyner, MD, MPH study director
University of North Carolina, Chapel Hill
Benny L Joyner, Jr., MD, MPH study chair
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Failure and Acute Respiratory Infection, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2017.