Viral-Related Neutrophil Response and Condition Severity in People With ARDS

NCT00548795 | Completed DMC

• 2 other identifiers: 1424R01HL090991
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 1

Brief 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. This study will evaluate the association between the immune response and ARDS severity in people who have ARDS plus a viral infection.

Conditions

Respiratory Distress Syndrome, Adult

Keywords

Acute Respiratory Distress Syndrome; ARDS; Neutrophil

Outcome Measures

Primary Outcomes (1)

• Primary outcome measure of subject mortality.

  baseline to 90 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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%
• 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

Sponsors & Collaborators

• National Jewish Health: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Colorado Health Sciences Center

Aurora, Colorado, 80010, United States

Location

Related Publications (2)

• 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.

  PMID: 27606687 BACKGROUND

• Malcolm 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.

  PMID: 21755013 RESULT

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Jerry A. Nick, MD

  National Jewish Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 22, 2007
• First Posted: October 24, 2007
• Study Start: August 1, 2007
• Primary Completion: January 1, 2011
• Study Completion: July 1, 2012
• Last Updated: October 14, 2020

Record last verified: 2020-10

Locations

US (1)