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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

Tracking Information
First Submitted Date  ICMJE September 15, 2009
First Posted Date  ICMJE September 17, 2009
Last Update Posted Date December 30, 2013
Study Start Date  ICMJE August 2009
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2009)
  • 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 ]
  • 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 ]
  • 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 ]
  • To determine patient and caregivers' satisfaction with the PleuRx® catheter using a questionnaire [ Time Frame: 2, 6, and 12 weeks post-catheter insertion ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Aggressive Versus Standard Drainage Regimen Using a Long Term Indwelling Pleural Catheter
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pleural Effusion, Malignant
Intervention  ICMJE
  • 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
  • Other: Aggressive Drainage Instructions
    Patients will receive specific instructions to drain up to 1 liter of pleural fluid daily
    Other Name: Daily Drainage
Study Arms  ICMJE
  • Experimental: Aggressive Drainage Arm
    Patients will drain up to 1 liter of pleural fluid everyday
    Intervention: Other: Aggressive Drainage Instructions
  • Active Comparator: Standard Drainage Arm
    Patients will drain up to 1 liter of pleural fluid every other day
    Intervention: Other: Standard Drainage Instructions
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 18, 2013)
150
Original Estimated Enrollment  ICMJE
 (submitted: September 16, 2009)
131
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00978939
Other Study ID Numbers  ICMJE Pro00016092
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Duke University
Original Responsible Party Momen Wahidi, MD, MBA - Director of Interventional Pulmonology Program, Duke University Medical Center
Current Study Sponsor  ICMJE Duke University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE CareFusion
Investigators  ICMJE
Principal Investigator: Momen Wahidi, MD, MBA Duke University
PRS Account Duke University
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP