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

2014-08-27 03:19:17 | BioPortfolio


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.


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 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 Design

Allocation: Randomized, Control: Historical Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Pleural Effusion, Malignant


Standard Drainage Instructions, Aggressive Drainage Instructions


National Jewish Medical Center
United States




Duke University

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:19:17-0400

Clinical Trials [1127 Associated Clinical Trials listed on BioPortfolio]

Impact of Draining Significant Effusion on Gas Exchange and Lung Mechanics in Patient Under Mechanical Ventilation

Patients with acute respiratory failure (ARF) who were receiving mechanical ventilator support, had significant pleural effusion (both transudates and exudates) and drainage plan were eval...

Vacuum vs Manual Drainage During Unilateral Thoracentesis

The purpose of this study is to determine if there are any differences in terms of safety, pain, or drainage speed between thoracenteses via manual drainage vs vacuum suction.

Drainage of Tuberculous Pleural Effusions

Tuberculous (TB) pleurisy can cause clinical symptoms and pleural fibrosis with resultant residual pleural thickening (RPT). Therapeutic thoracentesis or initial complete drainage in addit...

Evaluation and Outcome of Para-pneumonic Effusion

Pleural effusion is the accumulation of excess fluid in the pleural cavity, which results in disturbance of the equilibrium between vascular hydrostatic and oncotic pressures. The underlyi...

Pleural Effusion Following Cardiac Surgery: Prevalence, Risk Factors and Clinical Features

Pleural effusion is a common complication of cardiac surgery. The aim of this study was to determine the prevalence, characteristics and determinants of clinically significant pleural effu...

PubMed Articles [6269 Associated PubMed Articles listed on BioPortfolio]

A Rare Case Of Pleural Effusion Due To Prevotella Dentalis.

Prevotella dentalis is a Gram-negative anaerobic rod involved in various human diseases, especially oral infections. We report a rare case of a pleural effusion due to this microorganism in an elderly...

Diagnostic Accuracy of Interleukin-27 between Tuberculous Pleural Effusion and Malignant Pleural Effusion: A Meta-Analysis.

The concentration assay of pleural effusion interleukin-27 (IL-27) has raised concern for diagnosing tuberculous pleurisy. Compared with malignant pleural effusion (MPE), the concentration of IL-27 in...

Thoracic Ultrasound as an Early Predictor of Pleurodesis Success in Malignant Pleural Effusion.

Malignant pleural effusion (MPE) is common and imposes a significant burden on patients and health care providers. Most patients require definitive treatment, such as drainage and chemical pleurodesis...

Outpatient Talc Administration by Indwelling Pleural Catheter for Malignant Effusion.

Background Malignant pleural effusion affects more than 750,000 persons each year across Europe and the United States. Pleurodesis with the administration of talc in hospitalized patients is the most ...

Olanzapine-induced peripheral eosinophilia and eosinophilic pleural effusion: A case report.

Eosinophilic pleural effusion (EPE) is an eosinophil count ≥10% in pleural effusion, which is a rare condition in drug therapy.

Medical and Biotech [MESH] Definitions

Surgical creation of an opening (stoma) into the chest cavity for drainage; used in the treatment of pleural effusion, pneumothorax, hemothorax and empyema.

Set of instructions about how to prepare food for eating using specific instructions.

Presence of fluid in the pleural cavity resulting from excessive transudation or exudation from the pleural surfaces. It is a sign of disease and not a diagnosis in itself.

Plastic tubes used for drainage of air or fluid from the pleural space. Their surgical insertion is called tube thoracostomy.

Presence of fluid in the PLEURAL CAVITY as a complication of malignant disease. Malignant pleural effusions often contain actual malignant cells.

More From BioPortfolio on "Impact of Aggressive Versus Standard Drainage Regimen Using a Long Term Indwelling Pleural Catheter"

Quick Search


Relevant Topics

Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

An anesthesiologist (US English) or anaesthetist (British English) is a physician trained in anesthesia and perioperative medicine. Anesthesiologists are physicians who provide medical care to patients in a wide variety of (usually acute) situations. ...

Pulmonary relating to or associated with the lungs eg Asthma, chronic bronchitis, emphysema, COPD, Cystic Fibrosis, Influenza,  Lung Cancer, Pneumonia, Pulmonary Arterial Hypertension, Sleep Disorders etc Follow and track Lung Cancer News ...

Searches Linking to this Trial