A randomised controlled trial evaluating the efficacy of indwelling pleural catheters in persistent non-malignant symptomatic pleural effusions

orth Bristol NHS Trust0 sites68 target enrollmentJuly 15, 2015

Overview

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/34413152/ (added 07/04/2022)

Registry

who.int

Start Date

July 15, 2015

End Date

August 31, 2017

Last Updated

4 years ago

Study Type

Interventional

Sex

All

Sponsor

orth Bristol NHS Trust

•1\. Clinically confident diagnosis of non\-malignant pleural effusion secondary to either advanced stage CHF or liver failure requiring and amenable to pleural intervention for relief of breathlessness
•2\. Assessment by a cardiologist or hepatologist determining the presence of established heart failure or liver failure and a pleural effusion that persists despite optimised medical therapy
•3\. At least one previous therapeutic aspiration of pleural fluid with results consistent with the cause of the effusion being due to CHF or liver failure either:
•3\.1\. a transudate by Light’s criteria in cases of effusions due to liver failure OR
•3\.2\. either a transudate in effusions due to CHF or an exudate in cases where diuretics have been used and CHF can confidently be stated to be the cause
•4\. No evidence of malignancy on pleural fluid cytology
•5\. Expected survival \>12 weeks
•6\. Written informed consent to trial participation
•7\. Target Gender: Male \& Female
•8\. Lower Age Limit 18 years

•1\. Age \<18 years
•2\. Known pleural malignancy
•3\. Pleural fluid pH \< 7\.2
•4\. Previously sited indwelling pleural catheter on the side requiring intervention or current indwelling pleural catheter on the contralateral side
•5\. Pregnancy, lactation or intention to become pregnant
•6\. Inability to give informed consent
•7\. Absolute contraindication to IPC or therapeutic aspiration of pleural fluid
•8\. Patient has no access to a telephone