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

This study has been completed.
Sponsor:
Collaborators:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00234767
First received: October 5, 2005
Last updated: November 5, 2008
Last verified: November 2008
  Purpose

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


Condition Intervention Phase
Acute Respiratory Distress Syndrome
Acute Lung Injury
Lung Diseases
Device: Pulmonary Artery Catheter
Behavioral: Protocolized Fluid Management
Phase 3

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Economic Analysis of Pulmonary Artery Catheter Use (EA-PAC)

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Estimated Enrollment: 650
Study Start Date: September 2001
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Did not consent to economic substudy and long-term follow-up
  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: NCT00234767

Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Derek C Angus, MD, MPH University of Pittsburgh
  More Information

Additional Information:
No publications provided by University of Pittsburgh

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00234767     History of Changes
Other Study ID Numbers: R01 HS011620
Study First Received: October 5, 2005
Last Updated: November 5, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Acute Respiratory Distress Syndrome
ARDS
Acute Lung Injury
ALI
Cost-effectiveness
Pharmacoeconomics
Long-term follow-up

Additional relevant MeSH terms:
Syndrome
Lung Diseases
Respiratory Distress Syndrome, Newborn
Lung Injury
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Disease
Pathologic Processes
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on September 18, 2014