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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
CareFusion
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00978939
First received: September 15, 2009
Last updated: March 18, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention Phase
Pleural Effusion, Malignant
 Other: Standard Drainage Instructions
Other: Aggressive Drainage Instructions
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To determine patient and caregivers' satisfaction with the PleuRx® catheter using a questionnaire [ Time Frame: 2, 6, and 12 weeks post-catheter insertion ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: August 2009
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00978939

Locations
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
Principal Investigator: Momen Wahidi, MD, MBA Duke University
  More Information

Publications:

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00978939     History of Changes
Other Study ID Numbers: Pro00016092
Study First Received: September 15, 2009
Last Updated: March 18, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pleural Effusion
Pleural Effusion, Malignant
Pleural Diseases
Respiratory Tract Diseases
Pleural Neoplasms
 Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on May 16, 2013