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Impact of Aggressive Versus Standard Drainage Regimen Using a Long Term Indwelling Pleural Catheter (ASAP)

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.
 
ClinicalTrials.gov Identifier: NCT00978939
Recruitment Status : Completed
First Posted : September 17, 2009
Last Update Posted : December 30, 2013
Sponsor:
Collaborator:
CareFusion
Information provided by (Responsible Party):
Duke University

Study Description
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Brief Summary:
Purpose and Objective: The purpose of this study is to determine if the rate of spontaneous pleurodesis using the Pleurx® catheter could be increased by simply increasing the frequency of pleural drainage and, if so, whether catheter-related complications can be minimized and spare patients the need for long term management of the Pleurx® catheter.

Condition or disease Intervention/treatment Phase
Pleural Effusion, Malignant Other: Standard Drainage Instructions Other: Aggressive Drainage Instructions Phase 4

Detailed Description:

Study Population: Patients greater than 18 years of age with malignant pleural effusions will be identified and approached in clinic by the Principle and Co-Investigator. Informed consent will be obtained from qualified and interested patients.

Study Activities: Patients will be randomized to standard and aggressive drainage groups and complete questionnaires regarding their health. Patients will then receive the Pleurx® catheter for standard treatment of their malignant pleural effusions, obtain a chest-xray, and receive educational instruction and training on catheter drainage and told whether to drain everyday using a 1-liter bottle or every other day using a 600-cc bottle. Patients will complete a drainage diary on everyday they drain fluid which will provide information on drainage volume, fluid color, pain, and complications. At 2 weeks, 6 weeks, and 12 weeks post catheter placement, patients will return to clinic for follow-up at which time they will have an interval history and physical and chest xray and complete a questionnaires regarding their health and satisfaction.

Risks/Safety Issues: Risks associated with draining the catheter include: pneumothorax, re-expansion pulmonary edema, hypotension, circulatory collapse, and infection. All serious adverse events will be reported to the institutional review board: a) death - immediately; b) life-threatening within 7 calendar days; c) all other SAEs (serious adverse events) within 15 calendar days. Should there be a serious adverse event that occurs that increases the risk to the participants, the study will be stopped, an investigation will be conducted, and a findings report will be generated before the study is resumed.

Data Analysis: The principal endpoint is the incidence of successful pleurodesis utilizing an aggressive drainage protocol compared to the incidence of successful pleurodesis using a standard drainage protocol. An interim analysis will be performed after 3 months.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Aggressive Versus Standard Drainage Regimen Using a Long Term Indwelling Pleural Catheter on the Incidence of Auto-Pleurodesis in Patients With Malignant Pleural Effusions
Study Start Date : August 2009
Actual Primary Completion Date : March 2013
Actual Study Completion Date : October 2013
Arms and Interventions
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Arm Intervention/treatment
Experimental: Aggressive Drainage Arm
Patients will drain up to 1 liter of pleural fluid everyday
 Other: Aggressive Drainage Instructions
Patients will receive specific instructions to drain up to 1 liter of pleural fluid daily
Other Name: Daily Drainage
Active Comparator: Standard Drainage Arm
Patients will drain up to 1 liter of pleural fluid every other day
 Other: Standard Drainage Instructions
Patients will receive specific instructions to drain up to 1 liter of pleural fluid every other day
Other Name: Conventional Drainage


Outcome Measures
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Primary Outcome Measures :
  1. To compare the incidence of auto-pleurodesis utilizing aggressive drainage versus standard drainage protocols with the PleuRx® catheter [ Time Frame: 2, 6, and 12 weeks post-catheter insertion ]

Secondary Outcome Measures :
  1. To determine the median time to auto-pleurodesis utilizing aggressive drainage versus standard drainage protocols with the PleuRx® catheter [ Time Frame: 2, 6, and 12 weeks post-catheter insertion ]
  2. To assess the effects of aggressive drainage versus standard drainage protocols with the PleuRx® catheter on functional health status [ Time Frame: 2, 6, and 12 weeks post-catheter insertion ]
  3. To determine predictors of auto-pleurodesis (volume and rate of pleural fluid drainage, biochemical, and radiographic) using post-hoc analysis in both the aggressive and standard drainage protocols [ Time Frame: 2, 6, and 12 weeks post-catheter insertion ]
  4. To determine patient and caregivers' satisfaction with the PleuRx® catheter using a questionnaire [ Time Frame: 2, 6, and 12 weeks post-catheter insertion ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age greater than 18 years old

  2. Pleural effusion (etiology fulfilling one of the following criteria):

    • Malignant effusion confirmed by cytology or pleural biopsy
    • Exudative effusion in the setting of known malignancy with no other identifiable cause
    • Malignant effusion due to tumors that are historically rapidly responsive to systemic therapy (small cell lung cancer, hematological malignancies) will only be included if refractory to standard chemotherapy
  3. Symptoms such as shortness of breath, cough, or chest fullness/chest discomfort
  4. Age greater than 18 years old

  5. Pleural effusion (etiology fulfilling one of the following criteria):

    • Demonstration of symptomatic improvement after therapeutic thoracentesis (removal of ≤ 1.5 L of pleural fluid)
    • Recurrent pleural effusion after therapeutic thoracentesis

Exclusion Criteria:

  1. Projected life expectancy less than 30 days as predicted by Karnofsky Performance Status score less than 30
  2. Radiographic evidence of trapped lung - persistent lung collapse with failure of the lung to reexpand following drainage of a pleural effusion
  3. Radiographic evidence of loculated pleural fluid
  4. Previous attempted pleurodesis on the affected side
  5. Previous lobectomy or pneumonectomy on the affected side
  6. Patient receiving intrapleural chemotherapy
  7. Chylothorax - pleural effusion with triglyceride levels > 110 mg/dl or chylomicrons on lipoprotein analysis, most commonly due to trauma/obstruction of the thoracic duct
  8. Parapneumonic effusion - pleural effusion associated with pneumonia
  9. Empyema - infected pleural space as defined by purulent pleural fluid, positive gram stain, or positive culture
  10. Inability to adequately perform pleural drainage at home
  11. Uncorrectable bleeding disorder
  12. Skin infection at the site of intended catheter insertion
  13. Pregnancy
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00978939


Locations
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United States, Colorado
National Jewish Medical Center
Denver, Colorado, United States, 80206
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Lahey Clinic
Burlington, Massachusetts, United States, 01805
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132-4701
Sponsors and Collaborators
Duke University
CareFusion
Investigators
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Principal Investigator: Momen Wahidi, MD, MBA Duke University
More Information
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Publications:
Barkauskas CE, Wahidi MM. Rate of auto pleurodesis with the indwelling pleural catheter using an aggressive drainage protocol in patients with malignant pleural effusions. Submitted for American Thoracic Society 2006 Meeting.

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00978939    
Other Study ID Numbers: Pro00016092
First Posted: September 17, 2009    Key Record Dates
Last Update Posted: December 30, 2013
Last Verified: December 2013
Additional relevant MeSH terms:
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Pleural Effusion, Malignant
Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases
Pleural Neoplasms
 Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms