Study Stopped
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Betadine Pleurodesis Via Tunneled Pleural Catheters
Efficacy of Povidone-Iodine Instillation Via Tunneled Pleural Catheters in Achieving Pleurodesis: A Randomized Controlled Trial
1 other identifier
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2018
Typical duration for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2016
CompletedFirst Posted
Study publicly available on registry
November 29, 2016
CompletedStudy Start
First participant enrolled
July 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedJanuary 11, 2019
January 1, 2019
2.2 years
November 17, 2016
January 9, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Tunneled Pleural Catheter Removal
The time (in days) between Tunneled Pleural Catheter (TPC) placement to eventual removal within 6 months
0-6 months
Secondary Outcomes (18)
Pleurodesis Rate
2 months
Infection Rate
6 months
Death
6 months
Mechanical Complications
6 months
Baseline Borg Dyspnea Index
Baseline
- +13 more secondary outcomes
Study Arms (4)
Malignant Effusion - Usual Care
NO INTERVENTIONPatients 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.
Malignant Effusion with Pleurodesis
EXPERIMENTALPatients 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.
Benign Effusion - Usual Care
NO INTERVENTIONPatients 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.
Benign Effusion with Pleurodesis
EXPERIMENTALPatients 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.
Interventions
Intrapleural administration of Povidone-Iodine
Eligibility Criteria
You may qualify if:
- Requiring Tunneled Catheter Placement for a Pleural Effusion
You may not qualify if:
- Patient with a nonexpandable lung
- Non-english speaker
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
Related Publications (7)
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.
PMID: 22561614BACKGROUNDAhmed 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.
PMID: 25451360BACKGROUNDHak 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.
PMID: 26968653BACKGROUNDLight 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.
PMID: 22032427BACKGROUNDPenz 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.
PMID: 24832000BACKGROUNDVan 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.
PMID: 20697963BACKGROUNDWalker 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.
PMID: 27777372BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan T Puchalski, MD, MEd
Yale University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2016
First Posted
November 29, 2016
Study Start
July 1, 2018
Primary Completion
September 1, 2020
Study Completion
June 1, 2021
Last Updated
January 11, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share