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Molecular Epidemiology of ARDS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006496
Recruitment Status : Active, not recruiting
First Posted : November 17, 2000
Last Update Posted : March 4, 2021
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
David Christopher Christiani, Massachusetts General Hospital

Tracking Information
First Submitted Date November 16, 2000
First Posted Date November 17, 2000
Last Update Posted Date March 4, 2021
Study Start Date February 2000
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 18, 2014)
Risk of ARDS [ Time Frame: From admission to ICU ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: April 18, 2014)
Mortality [ Time Frame: From admission to ICU to 60 days ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: April 18, 2014)
Multi-organ Failure [ Time Frame: From admission to ICU ]
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Molecular Epidemiology of ARDS
Official Title Molecular Epidemiology of Acute Respiratory Distress Syndrome
Brief Summary To examine the possible relationship between genetic factors and the acute respiratory distress syndrome (ARDS).
Detailed Description


The acute respiratory distress syndrome (ARDS) remains a major cause of morbidity and mortality around the world. In the United States alone there are 150,000 cases per year. Although there have been significant scientific advances in understanding the clinical and pathophysical aspects of the syndrome, there is as yet no specific therapy for ARDS. Moreover, although major risk factors for the development of ARDS include sepsis, aspiration, and multiple trauma, only a minority of patients with these risk factors develop ARDS. Individual differences in susceptibility to chronic disease have been a subject of active molecular epidemiologic investigations for the past decade. In particular, risk factors for cancer conferred by heritable polymorphisms and various metabolic functions have been reported. More recently, a polymorphism of endothelial nitrate oxide synthase has been associated with an increased susceptibility to coronary-artery disease, and polymorphisms in GSTM1 have been associated with an increased risk of developing asbestosis. A recent study of tumor necrosis factor (TNF) polymorphisms has been associated with poor outcome in ARDS.


The case-control study examined the association between specific polymorphisms in several genes coding for specific inflammatory responses and for surfactant protein and their potential association with increased susceptibility to ARDS. The first objective was to assess the role of candidate-gene polymorphisms as risk factors for ARDS in a case-control study. The second objective was to assess the relationship between genotype and phenotype for candidate markers in cases and controls. The third objective was to assess the role of these polymorphisms in clinical outcome (survival, recovery) using patients from both the proposed case-control study and the multicenter case series and clinical trial sponsored by the NHLBI ARDS network. By combining both a large case-control study and case series from the network, the study had the advantages of sufficient case ascertainment, statistical power, diagnostic standardization, uniform outcome criteria and study efficiency. Overall, the results of this study should provide new insights into the epidemiology of ARDS and allow for possible preventive strategies as well as possible modifications of therapeutic interventions for the Network Phase III trials.

The investigators test the hypothesis that there is an increased risk of ARDS in patients with heritable traits relating to inflammatory cytokines and surfactant. They are examining risk and prognosis, and examining case and control genetics in relation to cytokine levels. They also plan to do a case-series analysis from a separate study of the ARDS network. They will examine TNF alpha and beta, interleukin-1 receptor antagonist, surfactant protein B and interleukin-10 (IL-10).

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Blood will be collected for DNA extraction and plasma cytokine measurements
Sampling Method Non-Probability Sample
Study Population All patients admitted to ICU with risk factors for ARDS
  • Acute Respiratory Distress Syndrome
  • Lung Diseases
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: April 18, 2014)
Original Enrollment Not Provided
Estimated Study Completion Date December 2022
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Eligibility Criteria:

All those with risk factors for ARDS - eg, pneumonia, trauma, sepsis.

Vulnerable populations (incarcerated, pregnant, etc.) will be excluded from enrollment. The following medical conditions will also exclude from study:

  1. immunocompromised patients
  2. patients with chronic lung disease that may appear like ARDS
  3. pulmonary vasculitis patients
  4. patients with diffuse alveolar hemorrhage
  5. patients treated with immune-modulating agents within 3 weeks of admission
  6. patients unable to intubate because of DNI order or patient is placed on comfort measures only
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
Administrative Information
NCT Number NCT00006496
Other Study ID Numbers 937
R01HL060710 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party David Christopher Christiani, Massachusetts General Hospital
Study Sponsor Massachusetts General Hospital
Collaborators National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: David Christiani, MD Harvard University School of Public Health
PRS Account Massachusetts General Hospital
Verification Date March 2021