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

NCT00978939 | Completed Phase 4 DMC

• 1 other identifier: Pro00016092
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 6

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.

Conditions

Pleural Effusion, Malignant

Outcome Measures

Primary Outcomes (1)

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

  2, 6, and 12 weeks post-catheter insertion

Secondary Outcomes (4)

• To determine the median time to auto-pleurodesis utilizing aggressive drainage versus standard drainage protocols with the PleuRx® catheter

  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

  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

  2, 6, and 12 weeks post-catheter insertion

• To determine patient and caregivers' satisfaction with the PleuRx® catheter using a questionnaire

  2, 6, and 12 weeks post-catheter insertion

Study Arms (2)

Aggressive Drainage Arm

EXPERIMENTAL

Patients will drain up to 1 liter of pleural fluid everyday

Other: Aggressive Drainage Instructions

Standard Drainage Arm

ACTIVE COMPARATOR

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

Other: Standard Drainage Instructions

Interventions

Standard Drainage Instructions OTHER

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

Also known as: Conventional Drainage

Standard Drainage Arm

Aggressive Drainage Instructions OTHER

Patients will receive specific instructions to drain up to 1 liter of pleural fluid daily

Also known as: Daily Drainage

Aggressive Drainage Arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• C. R. Bard: collaborator

Study Sites (6)

National Jewish Medical Center

Denver, Colorado, 80206, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

University of Utah

Salt Lake City, Utah, 84132-4701, United States

Location

Related Publications (3)

• 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.

  PMID: 16478853 BACKGROUND

• 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.

  PMID: 15627865 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Pleural Effusion, Malignant

Condition Hierarchy (Ancestors)

Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pleural Effusion; Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Momen Wahidi, MD, MBA

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2009
• First Posted: September 17, 2009
• Study Start: August 1, 2009
• Primary Completion: March 1, 2013
• Study Completion: October 1, 2013
• Last Updated: December 30, 2013

Record last verified: 2013-12

Locations

US (6)