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Betadine Pleurodesis Via Tunneled Pleural Catheters

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ClinicalTrials.gov Identifier: NCT02975921
Recruitment Status : Not yet recruiting
First Posted : November 29, 2016
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
Yale University

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.

Condition or disease Intervention/treatment Phase
Pleural Effusion Pleurodesis Malignant Pleural Effusion Pleural Effusion Due to Congestive Heart Failure Pleural Effusion in Conditions Classified Elsewhere Pleural Effusions, Chronic Drug: Povidone-Iodine Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Efficacy of Povidone-Iodine Instillation Via Tunneled Pleural Catheters in Achieving Pleurodesis: A Randomized Controlled Trial
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Malignant Effusion - Usual Care
Patients who had a pleural effusion secondary to a malignant etiology and subsequently underwent tunneled pleural catheter (TPC) placement and had usual care during and afterwards. Usual care is the TPC only with no intrapleural medications. They would have nursing care in the recovery area afterwards and home nursing three times weekly.
Experimental: Malignant Effusion with Pleurodesis
Patients who had a pleural effusion secondary to a malignant etiology and subsequently underwent tunneled pleural catheter (TPC) placement and had intrapleural Povidone-Iodine administered at time of placement (100mL of 2% solution). They would have nursing care in the recovery area afterwards and home nursing three times weekly.
Drug: Povidone-Iodine
Intrapleural administration of Povidone-Iodine
Other Name: Betadine

No Intervention: Benign Effusion - Usual Care
Patients who had a pleural effusion secondary to a benign etiology and subsequently underwent tunneled pleural catheter (TPC) placement and had usual care during and afterwards. Usual care is the TPC only with no intrapleural medications. They would have nursing care in the recovery area afterwards and home nursing three times weekly.
Experimental: Benign Effusion with Pleurodesis
Patients who had a pleural effusion secondary to a benign etiology and subsequently underwent tunneled pleural catheter (TPC) placement and had intrapleural Povidone-Iodine administered at time of placement (100mL of 2% solution). They would have nursing care in the recovery area afterwards and home nursing three times weekly.
Drug: Povidone-Iodine
Intrapleural administration of Povidone-Iodine
Other Name: Betadine




Primary Outcome Measures :
  1. Time to Tunneled Pleural Catheter Removal [ Time Frame: 0-6 months ]
    The time (in days) between Tunneled Pleural Catheter (TPC) placement to eventual removal within 6 months


Secondary Outcome Measures :
  1. Pleurodesis Rate [ Time Frame: 2 months ]
    Rate of patients who achieved successful pleurodesis within 2 months as defined as successful TPC removal with no reaccumulation of pleural effusion on subsequent imaging (usually 2-3 weeks later). Typical for usual care is 45-50%. In observational studies using povidone-iodine pleurodesis in other manners (not via TPC), a 90% pleurodesis rate was observed (which should be similar to our study with intervention).

  2. Infection Rate [ Time Frame: 6 months ]
    Any skin/site infections or empyemas (pleural based infections) noted within 6 months of TPC placement. The longer a TPC is in place, the higher the rate of infection we would expect. The expected infection rate is between 5-25% at 2 months and this should be dramatically lower in the intervention arm as most of them will have their TPCs removed within 1 week or so.

  3. Death [ Time Frame: 6 months ]
    Any deaths that occur and how long after TPC placement and the patients age at death. As patients are quite systemically ill when they receive TPCs, these comorbidities would be expected to be the primary drivers of patient mortality. Typical values seen in the literature is a mortality rate of 30-70% at 6 months. There should be essentially no difference between groups.

  4. Mechanical Complications [ Time Frame: 6 months ]
    Any mechanical complications related to the TPC itself such as catheter malfunction or accidental removal. This would be a rare complication and the expected rate will be <5%. The incidence of this will rise the longer it is in place for.

  5. Baseline Borg Dyspnea Index [ Time Frame: Baseline ]
    The Borg Dyspnea Index is a standardized, validated tool to measure a patient's dyspnea. This will be measured at baseline prior to Tunneled Pleural Catheter Placement.

  6. Borg Dyspnea Index at 2 weeks [ Time Frame: 2 weeks ]
    The Borg Dyspnea Index is a standardized, validated tool to measure a patient's dyspnea. This will be measured 2 weeks after tunneled pleural catheter placement.

  7. Borg Dyspnea Index at 2 months [ Time Frame: 2 months ]
    The Borg Dyspnea Index is a standardized, validated tool to measure a patient's dyspnea. This will be measured 2 months after tunneled pleural catheter placement.

  8. Borg Dyspnea Index at 4 months [ Time Frame: 4 months ]
    The Borg Dyspnea Index is a standardized, validated tool to measure a patient's dyspnea. This will be measured 4 months after tunneled pleural catheter placement.

  9. Borg Dyspnea Index at 6 months [ Time Frame: 6 months ]
    The Borg Dyspnea Index is a standardized, validated tool to measure a patient's dyspnea. This will be measured 6 months after tunneled pleural catheter placement.

  10. Quality of Life Questionnaire at Baseline [ Time Frame: Baseline ]
    Quality of Life will be measured via a WHOQOL-BREF questionnaire which is a standardized, validated tool to measure a patient's quality of life. This will be measured at baseline prior to the procedure.

  11. Quality of Life Questionnaire at 2 weeks [ Time Frame: 2 weeks ]
    Quality of Life will be measured via a WHOQOL-BREF questionnaire which is a standardized, validated tool to measure a patient's quality of life. This will be measured 2 weeks after TPC placement.

  12. Quality of Life Questionnaire at 2 months [ Time Frame: 2 months ]
    Quality of Life will be measured via a WHOQOL-BREF questionnaire which is a standardized, validated tool to measure a patient's quality of life. This will be measured 2 months after TPC placement.

  13. Quality of Life Questionnaire at 4 months [ Time Frame: 4 months ]
    Quality of Life will be measured via a WHOQOL-BREF questionnaire which is a standardized, validated tool to measure a patient's quality of life. This will be measured 4 months after TPC placement.

  14. Quality of Life Questionnaire at 6 months [ Time Frame: 6 months ]
    Quality of Life will be measured via a WHOQOL-BREF questionnaire which is a standardized, validated tool to measure a patient's quality of life. This will be measured 6 months after TPC placement.

  15. Baseline Pain [ Time Frame: Baseline ]
    Pain at baseline - immediately prior to procedure.

  16. Pain 2 hours after procedure [ Time Frame: 2 hours after procedure ]
    Pain at 2 hours after the procedure.

  17. Pain 6 hours after procedure [ Time Frame: 6 hours after procedure ]
    Pain at 6 hours after the procedure.

  18. Immediate hemodynamic reactions following betadine administration [ Time Frame: 0-6 hours after procedure ]
    Any severe hemodynamic fluctuations (such as severe hypotension or hypertension) noted after the procedure. The patient will monitored by nursing staff in a recovery area and any events will be noted immediately. The expected rate of this is <5%.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Requiring Tunneled Catheter Placement for a Pleural Effusion

Exclusion Criteria:

  • Patient with a nonexpandable lung
  • Non-english speaker

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02975921


Contacts
Contact: Amrik S Ray, MD 6084690396 amrik.ray@yale.edu
Contact: Zubaida Dabre, RN 203-737-4632 zubaida.dabre@yale.edu

Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Jonathan T Puchalski, MD, MEd Yale University

Publications:
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02975921     History of Changes
Other Study ID Numbers: 2000020017
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yale University:
Pleural Effusion
Thoracentesis
Pleural Cavity
Pleurodesis
Tunneled Pleural Catheter

Additional relevant MeSH terms:
Pleural Effusion
Pleural Effusion, Malignant
Heart Failure
Heart Diseases
Cardiovascular Diseases
Pleural Diseases
Respiratory Tract Diseases
Pleural Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Iodine
Cadexomer iodine
Povidone-Iodine
Povidone
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Plasma Substitutes
Blood Substitutes