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Study of the Economics of Pulmonary Artery Catheter Use in Patients With Acute Respiratory Distress Syndrome (ARDS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00234767
Recruitment Status : Completed
First Posted : October 7, 2005
Last Update Posted : November 7, 2008
Agency for Healthcare Research and Quality (AHRQ)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
University of Pittsburgh

Brief Summary:
Study of the long term outcomes and economic impact of the pulmonary artery catheter in acute respiratory distress syndrome (ARDS/ALI) patients.

Condition or disease Intervention/treatment
Acute Respiratory Distress Syndrome Acute Lung Injury Lung Diseases Device: Pulmonary Artery Catheter Behavioral: Protocolized Fluid Management

Detailed Description:

The pulmonary artery catheter (PAC) is a commonly used device that provides hemodynamic data to guide care of the critically ill, such as patients with acute lung injury or the acute respiratory distress syndrome (ARDS/ALI). Clinicians believe PAC use improves decision-making and patient outcomes but evidence is lacking and recent data suggest the PAC may increase mortality as well as considerably increasing costs. In response, the NHLBI funded a large multicenter trial (Fluid And Catheter Treatment Trial (FACTT) (N01-HR-46054-46064)) where ARDS/ALI patients were randomized to receive a PAC or the less invasive central venous catheter (CVC) and received a liberal or conservative fluid management protocol in response to data provided by the PAC or CVC. The primary end-point is in-patient mortality.

We are complementing FACTT with a concurrent economic analysis of the PAC. Our aims are to: 1.) compare differences between study arms in long-term survival, quality of life, and quality-adjusted survival; 2.) compare differences between study arms in acute care and long-term costs; 3.) calculate the cost-efficacy of PAC use (i.e., the balance of costs and effects under the controlled environment of the FACTT trial), and; 4.) estimate cost-effectiveness under more "real-world" conditions and produce life-time cost-effectiveness ratios, thereby facilitating comparison of our results to other cost-effectiveness analyses.

We are achieving Aims 1-3 by augmenting FACTT data collection with detailed information on hospital costs, extended survival follow-up for a minimum of one year, and post-discharge patient interviews to determine quality of life and resource use in the first year. We will achieve Aim 4 by constructing a microsimulation model first calibrated by results from FACTT and published data on life-expectancy and costs and then adjusted to reflect the broader patient case-mix and clinical effects of PAC use in routine clinical practice. We are using patient-level data from the King County Lung Injury Project epidemiology study (NHLBI HL-96-014) to adjust case-mix and patient-level data from a large pragmatic trial of PAC use in the United Kingdom to adjust the clinical effects of PAC use.

The results of our adjunct to FACTT will substantially amplify the value of the data being collected and provide, for the first time, robust estimates from randomized data of the economic effects of the widespread application of this important technology.

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Study Type : Observational
Enrollment : 650 participants
Time Perspective: Prospective
Official Title: Economic Analysis of Pulmonary Artery Catheter Use (EA-PAC)
Study Start Date : September 2001
Actual Primary Completion Date : August 2007

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Enrolled in the Fluid and Catheter Treatment Trial (FACTT)

Exclusion Criteria:

  • Did not consent to economic substudy and long-term follow-up

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00234767

Sponsors and Collaborators
University of Pittsburgh
Agency for Healthcare Research and Quality (AHRQ)
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: Derek C Angus, MD, MPH University of Pittsburgh

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00234767     History of Changes
Other Study ID Numbers: R01HS011620 ( U.S. AHRQ Grant/Contract )
First Posted: October 7, 2005    Key Record Dates
Last Update Posted: November 7, 2008
Last Verified: November 2008
Keywords provided by University of Pittsburgh:
Acute Respiratory Distress Syndrome
Acute Lung Injury
Long-term follow-up
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Injury
Pathologic Processes
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Wounds and Injuries