Acute Respiratory Distress SyndromeNCT00005318
ARDS - Clinical Epidemiology and the Role of the Inflammatory Response - SCOR in Acute Lung Injury
An observational study of Acute Respiratory Distress Syndrome and Lung Diseases, run by University of Minnesota.
Trial summary
To investigate the epidemiology of adult respiratory distress syndrome (ARDS) and the evolution of the inflammatory process in patients with acute lung injury. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Lung Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jan 1994to Nov 2004
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To investigate the epidemiology of adult respiratory distress syndrome (ARDS) and the evolution of the inflammatory process in patients with acute lung injury.
Read the 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 (ALI/ARDS) 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 ALI/ARDS in patients at risk.
- Conditions
- Acute Respiratory Distress Syndrome, Lung Diseases
- Medical subject headings
- Respiratory Distress Syndrome, Lung Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startJan 1994
- Study completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Leonard Hudson, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005318
- Sponsor's protocol ID
- 4091
- Other IDs
- P50HL050152
- Status last verified
- Oct 2019
- First submitted
- 25 May 2000
- Last updated
- 1 Nov 2019
- Results posted
- No
Publications
Hudson LD, Milberg JA, Anardi D, Maunder RJ. Clinical risks for development of the acute respiratory distress syndrome. Am J Respir Crit Care Med. 1995 Feb;151(2 Pt 1):293-301. doi: 10.1164/ajrccm.151.2.7842182.
PubMed 7842182Davidson TA, Rubenfeld GD, Caldwell ES, Hudson LD, Steinberg KP. The effect of acute respiratory distress syndrome on long-term survival. Am J Respir Crit Care Med. 1999 Dec;160(6):1838-42. doi: 10.1164/ajrccm.160.6.9903058.
PubMed 10588594Davidson TA, Caldwell ES, Curtis JR, Hudson LD, Steinberg KP. Reduced quality of life in survivors of acute respiratory distress syndrome compared with critically ill control patients. JAMA. 1999 Jan 27;281(4):354-60. doi: 10.1001/jama.281.4.354.
PubMed 9929089Madtes DK, Rubenfeld G, Klima LD, Milberg JA, Steinberg KP, Martin TR, Raghu G, Hudson LD, Clark JG. Elevated transforming growth factor-alpha levels in bronchoalveolar lavage fluid of patients with acute respiratory distress syndrome. Am J Respir Crit Care Med. 1998 Aug;158(2):424-30. doi: 10.1164/ajrccm.158.2.9711112.
PubMed 9700116Matute-Bello G, Liles WC, Radella F 2nd, Steinberg KP, Ruzinski JT, Jonas M, Chi EY, Hudson LD, Martin TR. Neutrophil apoptosis in the acute respiratory distress syndrome. Am J Respir Crit Care Med. 1997 Dec;156(6):1969-77. doi: 10.1164/ajrccm.156.6.96-12081.
PubMed 9412582Kurdowska A, Noble JM, Steinberg KP, Ruzinski J, Hudson LD, Martin TR. Anti-IL-8 autoantibodies in alveolar fluid from patients at risk for ARDS and with well-defined ARDS. Chest. 1999 Jul;116(1 Suppl):9S. doi: 10.1378/chest.116.suppl_1.9s. No abstract available.
PubMed 10424560Moss M, Parsons PE, Steinberg KP, Hudson LD, Guidot DM, Burnham EL, Eaton S, Cotsonis GA. Chronic alcohol abuse is associated with an increased incidence of acute respiratory distress syndrome and severity of multiple organ dysfunction in patients with septic shock. Crit Care Med. 2003 Mar;31(3):869-77. doi: 10.1097/01.CCM.0000055389.64497.11.
PubMed 12626999Treggiari MM, Hudson LD, Martin DP, Weiss NS, Caldwell E, Rubenfeld G. Effect of acute lung injury and acute respiratory distress syndrome on outcome in critically ill trauma patients. Crit Care Med. 2004 Feb;32(2):327-31. doi: 10.1097/01.CCM.0000108870.09693.42.
PubMed 14758144Johnston CJ, Rubenfeld GD, Hudson LD. Effect of age on the development of ARDS in trauma patients. Chest. 2003 Aug;124(2):653-9. doi: 10.1378/chest.124.2.653.
PubMed 12907556Rubenfeld GD, Cooper C, Carter G, Thompson BT, Hudson LD. Barriers to providing lung-protective ventilation to patients with acute lung injury. Crit Care Med. 2004 Jun;32(6):1289-93. doi: 10.1097/01.ccm.0000127266.39560.96.
PubMed 15187508
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARDS - Clinical Epidemiology and the Role of the Inflammatory Response - SCOR in Acute Lung Injury
- ClinicalTrials.gov ID
- NCT00005318
- Acronym / sponsor ID
- 4091
- Conditions
- Acute Respiratory Distress Syndrome, Lung Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 1994
- Study completion
- Nov 2004
- First posted
- 26 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (ALI/ARDS) 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 ALI/ARDS in patients at risk.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
- Background: PubMed 7842182Hudson LD, Milberg JA, Anardi D, Maunder RJ. Clinical risks for development of the acute respiratory distress syndrome. Am J Respir Crit Care Med. 1995 Feb;151(2 Pt 1):293-301. doi: 10.1164/ajrccm.151.2.7842182.
- Background: PubMed 10588594Davidson TA, Rubenfeld GD, Caldwell ES, Hudson LD, Steinberg KP. The effect of acute respiratory distress syndrome on long-term survival. Am J Respir Crit Care Med. 1999 Dec;160(6):1838-42. doi: 10.1164/ajrccm.160.6.9903058.
- Background: PubMed 9929089Davidson TA, Caldwell ES, Curtis JR, Hudson LD, Steinberg KP. Reduced quality of life in survivors of acute respiratory distress syndrome compared with critically ill control patients. JAMA. 1999 Jan 27;281(4):354-60. doi: 10.1001/jama.281.4.354.
- Background: PubMed 9700116Madtes DK, Rubenfeld G, Klima LD, Milberg JA, Steinberg KP, Martin TR, Raghu G, Hudson LD, Clark JG. Elevated transforming growth factor-alpha levels in bronchoalveolar lavage fluid of patients with acute respiratory distress syndrome. Am J Respir Crit Care Med. 1998 Aug;158(2):424-30. doi: 10.1164/ajrccm.158.2.9711112.
- Background: PubMed 9412582Matute-Bello G, Liles WC, Radella F 2nd, Steinberg KP, Ruzinski JT, Jonas M, Chi EY, Hudson LD, Martin TR. Neutrophil apoptosis in the acute respiratory distress syndrome. Am J Respir Crit Care Med. 1997 Dec;156(6):1969-77. doi: 10.1164/ajrccm.156.6.96-12081.
- Background: PubMed 10424560Kurdowska A, Noble JM, Steinberg KP, Ruzinski J, Hudson LD, Martin TR. Anti-IL-8 autoantibodies in alveolar fluid from patients at risk for ARDS and with well-defined ARDS. Chest. 1999 Jul;116(1 Suppl):9S. doi: 10.1378/chest.116.suppl_1.9s. No abstract available.
- Background: PubMed 12626999Moss M, Parsons PE, Steinberg KP, Hudson LD, Guidot DM, Burnham EL, Eaton S, Cotsonis GA. Chronic alcohol abuse is associated with an increased incidence of acute respiratory distress syndrome and severity of multiple organ dysfunction in patients with septic shock. Crit Care Med. 2003 Mar;31(3):869-77. doi: 10.1097/01.CCM.0000055389.64497.11.
- Background: PubMed 14758144Treggiari MM, Hudson LD, Martin DP, Weiss NS, Caldwell E, Rubenfeld G. Effect of acute lung injury and acute respiratory distress syndrome on outcome in critically ill trauma patients. Crit Care Med. 2004 Feb;32(2):327-31. doi: 10.1097/01.CCM.0000108870.09693.42.
- Background: PubMed 12907556Johnston CJ, Rubenfeld GD, Hudson LD. Effect of age on the development of ARDS in trauma patients. Chest. 2003 Aug;124(2):653-9. doi: 10.1378/chest.124.2.653.
- Background: PubMed 15187508Rubenfeld GD, Cooper C, Carter G, Thompson BT, Hudson LD. Barriers to providing lung-protective ventilation to patients with acute lung injury. Crit Care Med. 2004 Jun;32(6):1289-93. doi: 10.1097/01.ccm.0000127266.39560.96.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leonard Hudson
University of Washington
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome and Lung Diseases, run by University of Minnesota.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005318, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2019.