Respiratory Distress Syndrome, AdultNCT00548795
Viral-Related Neutrophil Response and Condition Severity in People With ARDS
An observational study of Respiratory Distress Syndrome, Adult, run by National Jewish Health at 1 site in United States.
Trial summary
Acute respiratory distress syndrome (ARDS) is a severe lung condition that can result from a bacterial infection in the lungs. Viral infections may impair the body's immune system response to bacteria, which may lead to more serious lung injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Distress Syndrome, Adult
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Jul 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults diagnosed with Acute Lung Injury [ALI] or Acute Respiratory Distress Syndrome [ARDS] admitted to Intensive Care Units that are ARDSNet sites in Colorado.
Who may be able to join
- All patients that are eligible for ARDSNet Study 06 (Prospective, Randomized, Multi-center Trial of Aerosolized Albuterol Versus Placebo in Patients with Acute Lung Injury [ALI] or Acute Respiratory Distress Syndrome [ARDS]) and ARDSNet Study 07 (Prospective, Randomized, Multi-center Trial of Initial Trophic Enteral Feeding Followed by Advancement to Full-Calorie Enteral Feeding vs. Early Advancement to Full-Calorie Enteral Feeding in Patients with Acute Lung Injury [ALI] or Acute Respiratory Distress Syndrome [ARDS] and Prospective, Randomized, Blinded, Placebo-controlled, Multi-center Trial of Omega-3 Fatty Acid, Gamma-Linolenic Acid, and Anti-Oxidant Supplementation in the Management of Acute Lung Injury [ALI] or Acute Respiratory Distress Syndrome [ARDS]) will be eligible for co-enrollment in this study
- Experiences acute onset of each of the following criteria within a 24-hour time period:
- Partial pressure of oxygen in arterial blood/fraction of inspired oxygen (PaO2/FiO2) less than or equal to 300; if altitude is greater than 1000 meters, then PaO2/FiO2 must be less than or equal to 300 x (barometric pressure [PB]/760)
- Bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph. The infiltrates may be patchy, diffuse, homogeneous, or asymmetric.
- Requires positive pressure ventilation via endotracheal tube
- No clinical evidence of left-sided cardiac failure to account for bilateral pulmonary infiltrates
- The 48-hour enrollment time window begins when the first three criteria are met. If a patient meets the first three inclusion criteria but has a pulmonary arterial wedge pressure (PAOP) greater than 18 mm Hg, then the first four criteria must persist for more than 12 hours after the PAOP has declined to less than or equal to 18 mm Hg, and still be within the 48-hour enrollment window.
Who cannot join
- More than 48 hours since all inclusion criteria were met
- Neuromuscular disease that impairs the ability to ventilate without assistance, such as cervical spinal cord injury at level C5 or higher, spinal cord injury, amyotrophic lateral sclerosis, Guillain-Barré syndrome, or myasthenia gravis
- Pregnant or breastfeeding
- Severe chronic respiratory disease, including chronic hypercapnia (arterial carbon dioxide pressure [PaCO2] greater than 45 mm Hg), chronic hypoxemia (PaO2 less than 55 mm Hg or FiO2 = 0.21), hospitalization within the 6 months prior to study entry for respiratory failure (PaCO2 greater than 50 mm Hg and/or PaO2 less than 55 mm Hg on 0.21 FiO2), secondary polycythemia, severe pulmonary hypertension (mean pulmonary arterial pressure [PAP] greater than 40 mm Hg), or ventilator dependency
- Burns over more than 40% of the total body surface area
- Cancer or other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50%
Show all 22Show fewer
- Allogeneic bone marrow transplant within the 5 years prior to study entry
- Patient, surrogate, or physician is not committed to full support (exception: a patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest)
- Severe chronic liver disease (i.e., Child-Pugh score between 11 and 15)
- Diffuse alveolar hemorrhage from vasculitis
- Morbid obesity (weighs greater than 1 kg/cm)
- Unwilling or unable to follow the ARDS network 6 mL/kg predicted body weight (PBW) ventilation protocol
- Not expected to survive 24 hours from the time of study entry
- No intent to obtain central venous access for monitoring intravascular pressures
- Medically unable to receive aerosolized albuterol
- Daily use (prior to study hospitalization) of inhaled beta agonist, corticosteroid, or oral leukotriene modifier
- Primary physician is unwilling to discontinue inpatient beta agonist use
- Acute heart attack or acute coronary syndrome within the 30 days prior to study entry
- Severe congestive heart failure
- Participation in other experimental medication trial in the 30 days prior to study entry with the exception of the ARDSNet pharmaconutrient nutrition trial (OMEGA)
- Heart rate greater than 85% of maximal predicted heart rate (MHR85) as calculated by MHR85 = 85% x (220-age)
- Receiving high frequency ventilation
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Health Sciences Center
Aurora, Colorado, 80010
About this study
Official title: A Prospective Assessment of Viral-induced Adaptation of Neutrophil Response in ARDS - Ancillary to ARDS Network Trials
Acute respiratory distress syndrome (ARDS) is a severe lung condition that can result from a bacterial infection in the lungs. Viral infections may impair the body's immune system response to bacteria, which may lead to more serious lung injury. This study will evaluate the association between the immune response and ARDS severity in people who have ARDS plus a viral infection.
Read the detailed description
ARDS is a serious condition that involves inflammation and fluid accumulation in the lungs, leading to low blood oxygen levels and breathing failure. It is often fatal and affects approximately 150,000 individuals each year in the United States. Common underlying causes include bacterial infections, lung trauma, and pneumonia. Even in people with similar risk factors for ARDS, there are often varying levels of condition severity. This may be because some people experience an ongoing viral infection that further predisposes them to the bacterial infection, worsening the severity of ARDS. Viruses release a protein called Type I interferon. This protein increases the response of the interferon stimulated genes (ISG) in neutrophils, which are white blood cells that protect the body against disease and infections by destroying bacteria. Preliminary studies have shown that some people at risk for ARDS have elevated ISGs in their neutrophils and that ISGs are associated with an impaired neutrophil response and increased severity of ARDS. This study will evaluate the association between viral-related neutrophil ISG response and the severity of ARDS.
Participants will include people on mechanical ventilation who are enrolled in either the ARDSNet 06 or 07 studies. For this study, participants will undergo blood collection within 48 hours of beginning the main ARDSNet study. There will be no study visits specifically for this study. Study researchers will analyze participants' blood samples and ARDSNet study data to gather information on mortality, the number of ventilator-free days, markers of severity of organ dysfunction and inflammation, and neutrophil response.
- Conditions
- Respiratory Distress Syndrome, Adult
- Keywords
- Acute Respiratory Distress Syndrome, ARDS, Neutrophil
- Medical subject headings
- Respiratory Distress Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome measure of subject mortality.
Measured: baseline to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2007 (estimated)
- Study startAug 2007
- Primary completionJan 2011
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress Syndrome, AdultStudies of the same condition, open and under way.
- 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
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Jerry A. Nick, M.D., National Jewish Health
- Investigators
- Jerry A. Nick, MD, Principal investigator, National Jewish Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00548795
- Sponsor's protocol ID
- 1424
- Other IDs
- R01HL090991
- Status last verified
- Oct 2020
- First submitted
- 22 Oct 2007
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nick JA, Caceres SM, Kret JE, Poch KR, Strand M, Faino AV, Nichols DP, Saavedra MT, Taylor-Cousar JL, Geraci MW, Burnham EL, Fessler MB, Suratt BT, Abraham E, Moss M, Malcolm KC. Extremes of Interferon-Stimulated Gene Expression Associate with Worse Outcomes in the Acute Respiratory Distress Syndrome. PLoS One. 2016 Sep 8;11(9):e0162490. doi: 10.1371/journal.pone.0162490. eCollection 2016.
PubMed 27606687Malcolm KC, Kret JE, Young RL, Poch KR, Caceres SM, Douglas IS, Coldren CD, Burnham EL, Moss M, Nick JA. Bacteria-specific neutrophil dysfunction associated with interferon-stimulated gene expression in the acute respiratory distress syndrome. PLoS One. 2011;6(7):e21958. doi: 10.1371/journal.pone.0021958. Epub 2011 Jul 6.
PubMed 21755013
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Assessment of Viral-induced Adaptation of Neutrophil Response in ARDS - Ancillary to ARDS Network Trials
- ClinicalTrials.gov ID
- NCT00548795
- Acronym / sponsor ID
- 1424
- Conditions
- Respiratory Distress Syndrome, Adult
- Keywords
- Acute Respiratory Distress Syndrome, ARDS, Neutrophil
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Aug 2007
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 24 Oct 2007 (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.
Acute respiratory distress syndrome (ARDS) is a severe lung condition that can result from a bacterial infection in the lungs. Viral infections may impair the body's immune system response to bacteria, which may lead to more serious lung injury. This study will evaluate the association between the immune response and ARDS severity in people who have ARDS plus a viral infection.
Detailed description
ARDS is a serious condition that involves inflammation and fluid accumulation in the lungs, leading to low blood oxygen levels and breathing failure. It is often fatal and affects approximately 150,000 individuals each year in the United States. Common underlying causes include bacterial infections, lung trauma, and pneumonia. Even in people with similar risk factors for ARDS, there are often varying levels of condition severity. This may be because some people experience an ongoing viral infection that further predisposes them to the bacterial infection, worsening the severity of ARDS. Viruses release a protein called Type I interferon. This protein increases the response of the interferon stimulated genes (ISG) in neutrophils, which are white blood cells that protect the body against disease and infections by destroying bacteria. Preliminary studies have shown that some people at risk for ARDS have elevated ISGs in their neutrophils and that ISGs are associated with an impaired neutrophil response and increased severity of ARDS. This study will evaluate the association between viral-related neutrophil ISG response and the severity of ARDS.
Participants will include people on mechanical ventilation who are enrolled in either the ARDSNet 06 or 07 studies. For this study, participants will undergo blood collection within 48 hours of beginning the main ARDSNet study. There will be no study visits specifically for this study. Study researchers will analyze participants' blood samples and ARDSNet study data to gather information on mortality, the number of ventilator-free days, markers of severity of organ dysfunction and inflammation, and neutrophil response.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults diagnosed with Acute Lung Injury [ALI] or Acute Respiratory Distress Syndrome [ARDS] admitted to Intensive Care Units that are ARDSNet sites in Colorado.
Key inclusion criteria (7 listed)
- All patients that are eligible for ARDSNet Study 06 (Prospective, Randomized, Multi-center Trial of Aerosolized Albuterol Versus Placebo in Patients with Acute Lung Injury [ALI] or Acute Respiratory Distress Syndrome [ARDS]) and ARDSNet Study 07 (Prospective, Randomized, Multi-center Trial of Initial Trophic Enteral Feeding Followed by Advancement to Full-Calorie Enteral Feeding vs. Early Advancement to Full-Calorie Enteral Feeding in Patients with Acute Lung Injury [ALI] or Acute Respiratory Distress Syndrome [ARDS] and Prospective, Randomized, Blinded, Placebo-controlled, Multi-center Trial of Omega-3 Fatty Acid, Gamma-Linolenic Acid, and Anti-Oxidant Supplementation in the Management of Acute Lung Injury [ALI] or Acute Respiratory Distress Syndrome [ARDS]) will be eligible for co-enrollment in this study
- Experiences acute onset of each of the following criteria within a 24-hour time period:
- The 48-hour enrollment time window begins when the first three criteria are met. If a patient meets the first three inclusion criteria but has a pulmonary arterial wedge pressure (PAOP) greater than 18 mm Hg, then the first four criteria must persist for more than 12 hours after the PAOP has declined to less than or equal to 18 mm Hg, and still be within the 48-hour enrollment window.
Key exclusion criteria (22 listed)
- More than 48 hours since all inclusion criteria were met
- Neuromuscular disease that impairs the ability to ventilate without assistance, such as cervical spinal cord injury at level C5 or higher, spinal cord injury, amyotrophic lateral sclerosis, Guillain-Barré syndrome, or myasthenia gravis
- Pregnant or breastfeeding
- Severe chronic respiratory disease, including chronic hypercapnia (arterial carbon dioxide pressure [PaCO2] greater than 45 mm Hg), chronic hypoxemia (PaO2 less than 55 mm Hg or FiO2 = 0.21), hospitalization within the 6 months prior to study entry for respiratory failure (PaCO2 greater than 50 mm Hg and/or PaO2 less than 55 mm Hg on 0.21 FiO2), secondary polycythemia, severe pulmonary hypertension (mean pulmonary arterial pressure [PAP] greater than 40 mm Hg), or ventilator dependency
- Burns over more than 40% of the total body surface area
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
Primary outcome measure of subject mortality.
Time frame: baseline to 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Background: PubMed 27606687Nick JA, Caceres SM, Kret JE, Poch KR, Strand M, Faino AV, Nichols DP, Saavedra MT, Taylor-Cousar JL, Geraci MW, Burnham EL, Fessler MB, Suratt BT, Abraham E, Moss M, Malcolm KC. Extremes of Interferon-Stimulated Gene Expression Associate with Worse Outcomes in the Acute Respiratory Distress Syndrome. PLoS One. 2016 Sep 8;11(9):e0162490. doi: 10.1371/journal.pone.0162490. eCollection 2016.
- Results publication: PubMed 21755013Malcolm KC, Kret JE, Young RL, Poch KR, Caceres SM, Douglas IS, Coldren CD, Burnham EL, Moss M, Nick JA. Bacteria-specific neutrophil dysfunction associated with interferon-stimulated gene expression in the acute respiratory distress syndrome. PLoS One. 2011;6(7):e21958. doi: 10.1371/journal.pone.0021958. Epub 2011 Jul 6.
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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.
Jerry A. Nick, MD principal investigator
National Jewish Health
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 Respiratory Distress Syndrome, Adult, run by National Jewish Health 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 7 inclusion and 22 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: finished, as of the sponsor's last update on 14 Oct 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary outcome measure of subject mortality. (time frame: baseline to 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00548795, which also lists 2 linked publications.
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 Oct 2020.