Molecular Epidemiology of Acute Respiratory Distress Syndrome (ARDS)

NCT00006496 | Active Not Recruiting

• 2 other identifiers: 937R01HL060710
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Respiratory Distress Syndrome; Lung Diseases

Outcome Measures

Primary Outcomes (1)

• Risk of ARDS

  From admission to ICU

Secondary Outcomes (1)

• Mortality

  From admission to ICU to 60 days

Other Outcomes (1)

• Multi-organ Failure

  From admission to ICU

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients admitted to ICU with risk factors for ARDS

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

• 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.

  PMID: 14718442 BACKGROUND

• 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.

  PMID: 15942330 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood will be collected for DNA extraction and plasma cytokine measurements

MeSH Terms

Conditions

Respiratory Distress Syndrome; Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Respiration Disorders

Study Officials

• David Christiani, MD

  Harvard University School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: November 16, 2000
• First Posted: November 17, 2000
• Study Start: February 1, 2000
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)