Abstract
Objective Refractory symptomatic transudative pleural effusions are an indication for pleural drainage. There has been supportive observational evidence for the use of indwelling pleural catheters (IPCs) for transudative effusions, but no randomised trials. We aimed to investigate the effect of IPCs on breathlessness in patients with transudative pleural effusions when compared with standard care.
Methods A multicentre randomised controlled trial, in which patients with transudative pleural effusions were randomly assigned to either an IPC (intervention) or therapeutic thoracentesis (TT; standard care). The primary outcome was mean daily breathlessness score over 12 weeks from randomisation.
Results 220 patients were screened from April 2015 to August 2019 across 13 centres, with 33 randomised to intervention (IPC) and 35 to standard care (TT). Underlying aetiology was heart failure in 46 patients, liver failure in 16 and renal failure in six. In primary outcome analysis, the mean±sd breathlessness score over the 12-week study period was 39.7±29.4 mm in the IPC group and 45.0±26.1 mm in the TT group (p=0.67). Secondary outcomes analysis demonstrated that mean±sd drainage was 17 412±17 936 mL and 2901±2416 mL in the IPC and TT groups, respectively. A greater proportion of patients had at least one adverse event in the IPC group (p=0.04).
Conclusion We found no significant difference in breathlessness over 12 weeks between IPCs or TT. TT is associated with fewer complications and IPCs reduced the number of invasive pleural procedures required. Patient preference and circumstances should be considered in selecting the intervention in this cohort.
Abstract
In the first randomised trial on refractory transudative pleural effusions, indwelling pleural catheters did not offer superior control of breathlessness compared to as required therapeutic thoracentesis https://bit.ly/36mR54x
Footnotes
This article has an editorial commentary: https://doi.org/10.1183/13993003.01942-2021
This study is a clinical trial registered as ISRCTN66354436. Individual de-identified participant data (including data dictionaries) will be shared. Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures and appendices) will be shared in particular. Study protocol and statistical analysis plan are the other documents available. Proposals should be directed to the corresponding author. To gain access, data requestors will need to sign a data access agreement.
Conflict of interest: S.P. Walker has nothing to disclose.
Conflict of interest: O. Bintcliffe has nothing to disclose.
Conflict of interest: E. Keenan has nothing to disclose.
Conflict of interest: L. Stadon has nothing to disclose.
Conflict of interest: M. Evison has nothing to disclose.
Conflict of interest: M. Haris has nothing to disclose.
Conflict of interest: T. Nagarajan has nothing to disclose.
Conflict of interest: A. West has nothing to disclose.
Conflict of interest: A. Ionescu has nothing to disclose.
Conflict of interest: B. Prudon has nothing to disclose.
Conflict of interest: A. Guhan has nothing to disclose.
Conflict of interest: R. Mustafa has nothing to disclose.
Conflict of interest: J. Herre has nothing to disclose.
Conflict of interest: D. Arnold has nothing to disclose.
Conflict of interest: R. Bhatnagar has nothing to disclose.
Conflict of interest: B. Kahan has nothing to disclose.
Conflict of interest: R.F. Miller has nothing to disclose.
Conflict of interest: N.M. Rahman reports personal fees for consultancy from Rocket Medical, outside the submitted work.
Conflict of interest: N.A. Maskell reports grants from BD Carefusion, during the conduct of the study; personal fees from BD Carefusion and Cook Medical, outside the submitted work.
- Received February 26, 2021.
- Accepted June 27, 2021.
- Copyright ©The authors 2022. For reproduction rights and permissions contact permissions{at}ersnet.org
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