Rapid Pleurodesis Through an Indwelling Pleural Catheter

Stopped early · Not applicable · Has a placebo group

Conditions studied: Pleural Effusion, Malignant, Pleurodesis, Pleural Diseases

In brief

The primary objective of the study is to evaluate whether the use of a rapid pleurodesis protocol using 10% iodopovidone immediately after tunneled pleural catheter placement improves time to IPC removal compared to patients who receive an IPC alone.

Key facts

Study ID

NCT03325192

Run by

University of Pennsylvania

People needed

11

Starts

2017-12-12

Expected to finish

2019-07-09

Last updated by the study team

2020-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of MPE as defined by
• A diagnosis a pleural effusion in the setting of known malignancy. AND
• Confirmed malignant involvement of the pleural space by fluid cytology or pleural biopsy. OR
• Evidence of pleural disease on radiographic imaging. OR
• A recurrent effusion with no other identifiable cause after thorough workup.
• Symptomatic from the pleural effusions (shortness of breath, cough, or chest pain)
• Prior thoracentesis with post procedure symptomatic relief
• Recurrence of symptoms with re-accumulation of pleural effusion
• Lung re-expansion after thoracentesis on chest imaging within last 30 days

You may not qualify if…

• Malignant pleural effusion due to a hematologic malignancy
• ECOG >4
• Any history of trapped lung
• Prior attempted pleurodesis on the affected site
• Age <18
• Pregnant or lactating
• Known allergy to iodopovidone (Betadine)
• Unable or unwilling to provide consent
• Uncorrectable coagulopathy (INR > 1.5, aPTT > 1.5 x the upper limit of normal) or thrombocytopenia (< 50,000)
• Anatomic contraindication to IPC (overlying skin abnormalities)
• Unable or unwilling to care for IPC and adhere to drainage protocol
• Need for bilateral IPC placement

Where it is running

• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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