Impact of Aggressive Versus Standard Drainage Regimen Using a Long Term Indwelling Pleural Catheter
NCT ID: NCT00978939
Last Updated: 2013-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
150 participants
INTERVENTIONAL
2009-08-31
2013-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Aggressive Drainage Arm
Patients will drain up to 1 liter of pleural fluid everyday
Aggressive Drainage Instructions
Patients will receive specific instructions to drain up to 1 liter of pleural fluid daily
Standard Drainage Arm
Patients will drain up to 1 liter of pleural fluid every other day
Standard Drainage Instructions
Patients will receive specific instructions to drain up to 1 liter of pleural fluid every other day
Interventions
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Standard Drainage Instructions
Patients will receive specific instructions to drain up to 1 liter of pleural fluid every other day
Aggressive Drainage Instructions
Patients will receive specific instructions to drain up to 1 liter of pleural fluid daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
19 Years
ALL
No
Sponsors
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CareFusion
INDUSTRY
Duke University
OTHER
Responsible Party
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Principal Investigators
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Momen Wahidi, MD, MBA
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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National Jewish Medical Center
Denver, Colorado, United States
Johns Hopkins University
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Lahey Clinic
Burlington, Massachusetts, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Utah
Salt Lake City, Utah, United States
Countries
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References
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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.
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.
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.
Other Identifiers
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Pro00016092
Identifier Type: -
Identifier Source: org_study_id