Pleural Effusion Clinical Trial
Official title:
Efficacy of Povidone-Iodine Instillation Via Tunneled Pleural Catheters in Achieving Pleurodesis: A Randomized Controlled Trial
The purpose of this study is to determine whether betadine (povidone-iodine) instillation during routine indwelling Tunneled Pleural Catheter (TPC) placement is efficacious in promoting pleurodesis and thus reducing the time to TPC removal.
Tunneled pleural catheter (TPC) placement is a routine clinical procedure used in the setting
of recurrent pleural effusions. The most common clinical indication is malignant pleural
effusion but these can be used in benign pleural effusions as well (such as those due to
congestive heart failure, cirrhosis, etc). The primary benefit of TPC placement is relief of
dyspnea without the need for recurrent procedures.
Despite success at relieving dyspnea, there are problems with the long-term placement of
TPC's. One risk is infection which is estimated at 5%. Furthermore, each drainage kit costs
approximately $100 and is often paid out-of-pocket by patients. Over time, this may create a
substantial cost burden. Finally, most patients who undergo TPC placement require home
drainage by visiting nurses. This is a significant resource utilization and it often requires
interruption of a patient's home routines via the visitation requirements.
Occasionally, the effusion no longer reaccumulates following TPC placement. In malignant
effusions, this pleurodesis (see below) occurs up to 50% of the time in malignant effusions.
When pleurodesis occurs, the TPC may be removed by a simple office procedure.
Pleurodesis, or the act of inducing scarring and obliteration of the potential space between
the visceral and parietal pleura where pleural effusions develop, is a different mechanism of
providing relief of dyspnea. In the USA in particular, the most common agent used for
pleurodesis (talc) is associated with complications such as respiratory failure and adult
respiratory distress syndrome (ARDS), a life-threatening condition. Talc is also very
expensive.
Povidone-Iodine, an agent used for pleurodesis in many other countries, has been shown to be
highly efficacious when given via other modalities. Studies report a pleurodesis rate of 90+%
with Povidone-Iodine. It also has a favorable safety record and is inexpensive.
Given all of these factors, the investigators propose a prospective study using
Povidone-Iodine at the time of TPC placement to promote pleurodesis. The investigators
hypothesize that pleurodesis will occur quickly and frequently, thus enabling removal of the
TPC, thereby saving cost, risks of infection, all while improving patients quality of life.
The investigators plan on doing this by enrolling patients prospectively who are to undergo
TPC placement as part of their standard care. These patients would be prospectively enrolled
and randomized to receive either usual care (no pleurodesis) or the investigational
medication (povidone-iodine) intrapleurally at time of procedure. The investigators would
subdivide groups prospectively between patients who have malignant pleural effusions and
those who have benign (non-malignant) pleural effusions.
Following TPC placement and medication administration (if necessary), nursing and
investigative physicians would then immediately follow them in the recovery area (to monitor
for any negative immediate outcomes such as hypertension, hypotension, reactions, or
significant pain) and in clinic as per their usual care (starting 1-2 weeks after discharge
and as long as necessary). The investigators would monitor them for the outcomes as noted
elsewhere.
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