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Rapid Pleurodesis Through an Indwelling Pleural Catheter

NCT03325192 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2020-05-08

No results posted yet for this study

Summary

The primary objective of the study is to evaluate whether the use of a rapid pleurodesis protocol using 10% iodopovidone immediately after tunneled pleural catheter placement improves time to IPC removal compared to patients who receive an IPC alone.

Conditions

  • Pleural Effusion, Malignant
  • Pleurodesis
  • Pleural Diseases

Interventions

DRUG

Rapid pleurodesis protocol

* The pleural space will be evacuated completely through the newly placed IPC * 20mL of 10% iodopovidone and 80mL of normal saline will be instilled into the pleural space * The patient will be transferred to the recovery unit * Two hours after instillation the pleural space will be drained * After recovery from anesthesia and complete drainage of the pleurodesis mix, the subject will be discharged * Subjects will be asked to drain their effusion on a daily basis for the next 7 days and then on an every other day basis.

OTHER

Placebo

* The pleural space will be evacuated completely through the newly placed IPC * Only placebo (normal saline) will be instilled into the pleural space * The patient will be transferred to the recovery unit * Two hours after instillation the pleural space will be drained * After recovery from anesthesia and complete drainage of the pleurodesis mix, the subject will be discharged * Subjects will be asked to drain their effusion on a daily basis for the next 7 days and then on an every other day basis.

Sponsors & Collaborators

Principal Investigators

  • Kevin C Ma · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-12
Primary Completion
2019-07-09
Completion
2019-07-09

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03325192 on ClinicalTrials.gov