Molecular Epidemiology of ARDS

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Massachusetts General Hospital
Sponsor:
Collaborator:
Information provided by (Responsible Party):
David Christopher Christiani, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00006496
First received: November 16, 2000
Last updated: April 18, 2014
Last verified: April 2014
  Purpose

To examine the possible relationship between genetic factors and the acute respiratory distress syndrome (ARDS).


Condition
Acute Respiratory Distress Syndrome
Lung Diseases

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Risk of ARDS [ Time Frame: From admission to ICU ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mortality [ Time Frame: From admission to ICU to 60 days ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Multi-organ Failure [ Time Frame: From admission to ICU ] [ Designated as safety issue: No ]

Estimated Enrollment: 4000
Study Start Date: February 2000
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
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).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients admitted to ICU with risk factors for ARDS

Criteria

Eligibility Criteria:

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006496

Contacts
Contact: David C Christiani, MD, MPH 617-726-9274 dchristiani@partners.org
Contact: Andrea Shafer, MPH 617-726-9274 ashafer@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Andrea Shafer, MPH    617-726-9274    ashafer@partners.org   
Contact: Ednan Bajwa, MD    617-726-9274    ebajwa@partners.org   
Principal Investigator: David C Christiani, MD.MPH         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: David Christiani, MD Harvard University School of Public Health
  More Information

Publications:
Responsible Party: David Christopher Christiani, Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00006496     History of Changes
Other Study ID Numbers: 937, R01HL060710
Study First Received: November 16, 2000
Last Updated: April 18, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Lung Diseases
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury

ClinicalTrials.gov processed this record on August 19, 2014