Clinical trial NCT02975921: Betadine Pleurodesis Via Tunneled Pleural Catheters
Official title: Efficacy of Povidone-Iodine Instillation Via Tunneled Pleural Catheters in Achieving Pleurodesis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Pleural Effusion
Pleurodesis
Malignant Pleural Effusion
Pleural Effusion Due to Congestive Heart Failure
Pleural Effusion in Conditions Classified Elsewhere
Pleural Effusions, Chronic
Keywords: Pleural Effusion
Thoracentesis
Pleural Cavity
Pleurodesis
Tunneled Pleural Catheter
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2016-11-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Requiring Tunneled Catheter Placement for a Pleural Effusion

Exclusion Criteria:

* Patient with a nonexpandable lung
* Non-english speaker

Primary outcomes:
measure: Time to Tunneled Pleural Catheter Removal
timeFrame: 0-6 months
Secondary outcomes:
measure: Pleurodesis Rate
timeFrame: 2 months
measure: Infection Rate
timeFrame: 6 months
measure: Death
timeFrame: 6 months
measure: Mechanical Complications
timeFrame: 6 months
measure: Baseline Borg Dyspnea Index
timeFrame: Baseline
measure: Borg Dyspnea Index at 2 weeks
timeFrame: 2 weeks
measure: Borg Dyspnea Index at 2 months
timeFrame: 2 months
measure: Borg Dyspnea Index at 4 months
timeFrame: 4 months
measure: Borg Dyspnea Index at 6 months
timeFrame: 6 months
measure: Quality of Life Questionnaire at Baseline
timeFrame: Baseline
measure: Quality of Life Questionnaire at 2 weeks
timeFrame: 2 weeks
measure: Quality of Life Questionnaire at 2 months
timeFrame: 2 months
measure: Quality of Life Questionnaire at 4 months
timeFrame: 4 months
measure: Quality of Life Questionnaire at 6 months
timeFrame: 6 months
measure: Baseline Pain
timeFrame: Baseline
measure: Pain 2 hours after procedure
timeFrame: 2 hours after procedure
measure: Pain 6 hours after procedure
timeFrame: 6 hours after procedure
measure: Immediate hemodynamic reactions following betadine administration
timeFrame: 0-6 hours after procedure
Other outcomes:
Locations:
Study officials:
affiliation: Yale University
name: Jonathan T Puchalski, MD, MEd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Agarwal R, Khan A, Aggarwal AN, Gupta D. Efficacy & safety of iodopovidone pleurodesis: a systematic review & meta-analysis. Indian J Med Res. 2012 Mar;135(3):297-304.
citation: Ahmed L, Ip H, Rao D, Patel N, Noorzad F. Talc pleurodesis through indwelling pleural catheters for malignant pleural effusions: retrospective case series of a novel clinical pathway. Chest. 2014 Dec;146(6):e190-e194. doi: 10.1378/chest.14-0394.
citation: Hak CC, Sivakumar P, Ahmed L. Safety of indwelling pleural catheter use in patients undergoing chemotherapy: a five-year retrospective evaluation. BMC Pulm Med. 2016 Mar 11;16:41. doi: 10.1186/s12890-016-0203-7.
citation: Light RW. Pleural effusions. Med Clin North Am. 2011 Nov;95(6):1055-70. doi: 10.1016/j.mcna.2011.08.005. Epub 2011 Sep 25.
citation: Penz ED, Mishra EK, Davies HE, Manns BJ, Miller RF, Rahman NM. Comparing cost of indwelling pleural catheter vs talc pleurodesis for malignant pleural effusion. Chest. 2014 Oct;146(4):991-1000. doi: 10.1378/chest.13-2481.
citation: Van Meter ME, McKee KY, Kohlwes RJ. Efficacy and safety of tunneled pleural catheters in adults with malignant pleural effusions: a systematic review. J Gen Intern Med. 2011 Jan;26(1):70-6. doi: 10.1007/s11606-010-1472-0. Epub 2010 Aug 10.
citation: Walker S, Bibby AC, Maskell NA. Current best practice in the evaluation and management of malignant pleural effusions. Ther Adv Respir Dis. 2017 Feb;11(2):105-114. doi: 10.1177/1753465816671697. Epub 2016 Oct 24.