- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00006496
Molecular Epidemiology of ARDS
Molecular Epidemiology of Acute Respiratory Distress Syndrome
Study Overview
Status
Conditions
Detailed Description
BACKGROUND:
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.
DESIGN NARRATIVE:
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
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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:
- immunocompromised patients
- patients with chronic lung disease that may appear like ARDS
- pulmonary vasculitis patients
- patients with diffuse alveolar hemorrhage
- patients treated with immune-modulating agents within 3 weeks of admission
- patients unable to intubate because of DNI order or patient is placed on comfort measures only
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Risk of ARDS
Time Frame: From admission to ICU
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From admission to ICU
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Mortality
Time Frame: From admission to ICU to 60 days
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From admission to ICU to 60 days
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Multi-organ Failure
Time Frame: From admission to ICU
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From admission to ICU
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: David Christiani, MD, Harvard University School of Public Health
Publications and helpful links
General Publications
- Gong MN, Wei Z, Xu LL, Miller DP, Thompson BT, Christiani DC. Polymorphism in the surfactant protein-B gene, gender, and the risk of direct pulmonary injury and ARDS. Chest. 2004 Jan;125(1):203-11. doi: 10.1378/chest.125.1.203.
- Gong MN, Thompson BT, Williams P, Pothier L, Boyce PD, Christiani DC. Clinical predictors of and mortality in acute respiratory distress syndrome: potential role of red cell transfusion. Crit Care Med. 2005 Jun;33(6):1191-8. doi: 10.1097/01.ccm.0000165566.82925.14.
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 937
- R01HL060710 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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