Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005318
Status:
COMPLETED
Last Update Posted:
2019-11-01
First Post:
2000-05-25
Brief Title:
ARDS - Clinical Epidemiology and the Role of the Inflammatory Response - SCOR in Acute Lung Injury
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To investigate the epidemiology of adult respiratory distress syndrome ARDS and the evolution of the inflammatory process in patients with acute lung injury
Detailed Description:
BACKGROUND
The results provided a a better understanding of the evolution of inflammation in clinical conditions leading to lung injury b a better understanding of the mechanisms of the initial injury and its propagation and c information that will help predict the course and outcome in individual patients These data should be useful in guiding the choice and timing of specific therapeutic interventions
DESIGN NARRATIVE
The study was a subproject within a Specialized Center of Research SCOR in Acute Lung Injury Leonard Hudson was the subproject principal investigator The epidemiological aspects focussed on refining clinical criteria that predicted patients at high risk for the onset of ARDS and identifying these patients as early as possible before the onset of lung injury The major hypothesis was that uncontrolled and sustained alveolar inflammation increased the severity of ARDS and prolonged its course and that sustained inflammation was more likely to occur when ARDS followed sepsis syndrome than multiple trauma The investigators also tested the hypothesis that the pattern of the inflammatory response in blood and lungs was an important determinant of whether lung inflammation persisted or resolved Important components of the inflammatory response studied included 1 a coordinated sequence of cytokines in blood and lung lavage fluid 2 the expression of adhesion molecules on blood leukocytes 3 circulating markers of diffuse endothelial injury VWF and ELAM1 4 products of the arachidonic acid cascade 5 the induction of endogenous proteins that modified the host response to bacterial products such as endotoxin and 6 inflammatory cell populations and proteins in the lung Patterns of inflammation were correlated with clinical risks critical clinical events and outcome measures
The study was renewed in 1999 to develop clinical prediction tools that provide individual risk assessment for the onset and outcome of lung injury determine the incidence and outcome of acute lung injury adult respiratory distress syndrome ALIARDS in populations beyond a single institution determine the relationship between inflammatory responses and injury to the lung endothelial and epithelial barriers and investigate determinants of host susceptibility that modulate the occurrence of ALIARDS in patients at risk
The results provided a a better understanding of the evolution of inflammation in clinical conditions leading to lung injury b a better understanding of the mechanisms of the initial injury and its propagation and c information that will help predict the course and outcome in individual patients These data should be useful in guiding the choice and timing of specific therapeutic interventions
DESIGN NARRATIVE
The study was a subproject within a Specialized Center of Research SCOR in Acute Lung Injury Leonard Hudson was the subproject principal investigator The epidemiological aspects focussed on refining clinical criteria that predicted patients at high risk for the onset of ARDS and identifying these patients as early as possible before the onset of lung injury The major hypothesis was that uncontrolled and sustained alveolar inflammation increased the severity of ARDS and prolonged its course and that sustained inflammation was more likely to occur when ARDS followed sepsis syndrome than multiple trauma The investigators also tested the hypothesis that the pattern of the inflammatory response in blood and lungs was an important determinant of whether lung inflammation persisted or resolved Important components of the inflammatory response studied included 1 a coordinated sequence of cytokines in blood and lung lavage fluid 2 the expression of adhesion molecules on blood leukocytes 3 circulating markers of diffuse endothelial injury VWF and ELAM1 4 products of the arachidonic acid cascade 5 the induction of endogenous proteins that modified the host response to bacterial products such as endotoxin and 6 inflammatory cell populations and proteins in the lung Patterns of inflammation were correlated with clinical risks critical clinical events and outcome measures
The study was renewed in 1999 to develop clinical prediction tools that provide individual risk assessment for the onset and outcome of lung injury determine the incidence and outcome of acute lung injury adult respiratory distress syndrome ALIARDS in populations beyond a single institution determine the relationship between inflammatory responses and injury to the lung endothelial and epithelial barriers and investigate determinants of host susceptibility that modulate the occurrence of ALIARDS in patients at risk
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P50HL050152 | NIH | None | httpsreporternihgovquickSearchP50HL050152 |