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

Primary Purpose

Pleural Effusion, Malignant

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Standard Drainage Instructions
Aggressive Drainage Instructions
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pleural Effusion, Malignant

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Jewish Medical Center
  • Johns Hopkins University
  • Beth Israel Deaconess Medical Center
  • Lahey Clinic
  • Duke University Medical Center
  • University of Utah

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aggressive Drainage Arm

Standard Drainage Arm

Arm Description

Patients will drain up to 1 liter of pleural fluid everyday

Patients will drain up to 1 liter of pleural fluid every other day

Outcomes

Primary Outcome Measures

To compare the incidence of auto-pleurodesis utilizing aggressive drainage versus standard drainage protocols with the PleuRx® catheter

Secondary Outcome Measures

To determine the median time to auto-pleurodesis utilizing aggressive drainage versus standard drainage protocols with the PleuRx® catheter
To assess the effects of aggressive drainage versus standard drainage protocols with the PleuRx® catheter on functional health status
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
To determine patient and caregivers' satisfaction with the PleuRx® catheter using a questionnaire

Full Information

First Posted
September 15, 2009
Last Updated
December 27, 2013
Sponsor
Duke University
Collaborators
CareFusion
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1. Study Identification

Unique Protocol Identification Number
NCT00978939
Brief Title
Impact of Aggressive Versus Standard Drainage Regimen Using a Long Term Indwelling Pleural Catheter
Acronym
ASAP
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 Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
CareFusion

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleural Effusion, Malignant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aggressive Drainage Arm
Arm Type
Experimental
Arm Description
Patients will drain up to 1 liter of pleural fluid everyday
Arm Title
Standard Drainage Arm
Arm Type
Active Comparator
Arm Description
Patients will drain up to 1 liter of pleural fluid every other day
Intervention Type
Other
Intervention Name(s)
Standard Drainage Instructions
Other Intervention Name(s)
Conventional Drainage
Intervention Description
Patients will receive specific instructions to drain up to 1 liter of pleural fluid every other day
Intervention Type
Other
Intervention Name(s)
Aggressive Drainage Instructions
Other Intervention Name(s)
Daily Drainage
Intervention Description
Patients will receive specific instructions to drain up to 1 liter of pleural fluid daily
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
Title
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
Title
To determine patient and caregivers' satisfaction with the PleuRx® catheter using a questionnaire
Time Frame
2, 6, and 12 weeks post-catheter insertion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age greater than 18 years old 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 Symptoms such as shortness of breath, cough, or chest fullness/chest discomfort Age greater than 18 years old 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: Projected life expectancy less than 30 days as predicted by Karnofsky Performance Status score less than 30 Radiographic evidence of trapped lung - persistent lung collapse with failure of the lung to reexpand following drainage of a pleural effusion Radiographic evidence of loculated pleural fluid Previous attempted pleurodesis on the affected side Previous lobectomy or pneumonectomy on the affected side Patient receiving intrapleural chemotherapy Chylothorax - pleural effusion with triglyceride levels > 110 mg/dl or chylomicrons on lipoprotein analysis, most commonly due to trauma/obstruction of the thoracic duct Parapneumonic effusion - pleural effusion associated with pneumonia Empyema - infected pleural space as defined by purulent pleural fluid, positive gram stain, or positive culture Inability to adequately perform pleural drainage at home Uncorrectable bleeding disorder Skin infection at the site of intended catheter insertion Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Momen Wahidi, MD, MBA
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Jewish Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Lahey Clinic
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132-4701
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16478853
Citation
Tremblay A, Michaud G. Single-center experience with 250 tunnelled pleural catheter insertions for malignant pleural effusion. Chest. 2006 Feb;129(2):362-368. doi: 10.1378/chest.129.2.362.
Results Reference
background
PubMed Identifier
15627865
Citation
Musani AI, Haas AR, Seijo L, Wilby M, Sterman DH. Outpatient management of malignant pleural effusions with small-bore, tunneled pleural catheters. Respiration. 2004 Nov-Dec;71(6):559-66. doi: 10.1159/000081755.
Results Reference
background
Citation
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.
Results Reference
background

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

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