Betadine Pleurodesis Via Tunneled Pleural Catheters

January 9, 2019 updated by: Yale University

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Requiring Tunneled Catheter Placement for a Pleural Effusion

Exclusion Criteria:

  • Patient with a nonexpandable lung
  • Non-english speaker

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Betadine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
0-6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 months
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.
6 months
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.
6 months
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.
6 months
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.
Baseline
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.
2 weeks
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.
2 months
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.
4 months
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.
6 months
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.
Baseline
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.
2 weeks
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.
2 months
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.
4 months
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.
6 months
Baseline Pain
Time Frame: Baseline
Pain at baseline - immediately prior to procedure.
Baseline
Pain 2 hours after procedure
Time Frame: 2 hours after procedure
Pain at 2 hours after the procedure.
2 hours after procedure
Pain 6 hours after procedure
Time Frame: 6 hours after procedure
Pain at 6 hours after the procedure.
6 hours after procedure
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%.
0-6 hours after procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2018

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

November 17, 2016

First Submitted That Met QC Criteria

November 28, 2016

First Posted (Estimate)

November 29, 2016

Study Record Updates

Last Update Posted (Actual)

January 11, 2019

Last Update Submitted That Met QC Criteria

January 9, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000020017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe