A feasibility randomised trial comparing therapeutic thoracentesis to chest tube insertion for the management of pleural infection: results from the ACTion trial

Arnold, David; Tucker, Emma; Morley, Anna; Milne, Alice E.; Stadon, Louise; Patole, Sonia; Nava, George W.; Walker, Steven; Maskell, Nick A

doi:10.1186/s12890-022-02126-4

Cited by 5 publications

(3 citation statements)

References 20 publications

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“…Nonetheless, although most eligible patients agreed to be randomly allocated to surgery, and that anesthesia risk precluded only a minority of participants from this allocation, a minimum fitness criterion may potentially optimize compliance in a future phase III study while maintaining the strength of MIST-3 in avoiding the selection bias of previous surgical RCTs ( 13 , 14 ), and the latter patients in their seventh and eighth decades of life were successfully treated surgically. With increasing experience, expertise, and safety demonstrated with VATS as a treatment modality, we strongly advocate that such patients are included in future trials given their increasing representation in pleural infection cohorts ( 28 ).…”

Section: Discussionmentioning

confidence: 99%

Early Video-assisted Thoracoscopic Surgery or Intrapleural Enzyme Therapy in Pleural Infection: A Feasibility Randomized Controlled Trial. The Third Multicenter Intrapleural Sepsis Trial—MIST-3

Bedawi,

Stavroulias,

Hedley

et al. 2023

Am J Respir Crit Care Med

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Rationale Assessing the early use of video-assisted thoracoscopic surgery (VATS) or intrapleural enzyme therapy (IET) in pleural infection requires a phase III randomized controlled trial (RCT). Objectives To establish the feasibility of randomization in a surgery-versus-nonsurgery trial as well as the key outcome measures that are important to identify relevant patient-centered outcomes in a subsequent RCT. Methods The MIST-3 (third Multicenter Intrapleural Sepsis Trial) was a prospective multicenter RCT involving eight U.K. centers combining on-site and off-site surgical services. The study enrolled all patients with a confirmed diagnosis of pleural infection and randomized those with ongoing pleural sepsis after an initial period (as long as 24 h) of standard care to one of three treatment arms: continued standard care, early IET, or a surgical opinion with regard to early VATS. The primary outcome was feasibility based on >50% of eligible patients being successfully randomized, >95% of randomized participants retained to discharge, and >80% of randomized participants retained to 2 weeks of follow-up. The analysis was performed per intention to treat. Measurements and Main Results Of 97 eligible patients, 60 (62%) were randomized, with 100% retained to discharge and 84% retained to 2 weeks. Baseline demographic, clinical, and microbiological characteristics of the patients were similar across groups. Median times to intervention were 1.0 and 3.5 days in the IET and surgery groups, respectively ( P = 0.02). Despite the difference in time to intervention, length of stay (from randomization to discharge) was similar in both intervention arms (7 d) compared with standard care (10 d) ( P = 0.70). There were no significant intergroup differences in 2-month readmission and further intervention, although the study was not adequately powered for this outcome. Compared with VATS, IET demonstrated a larger improvement in mean EuroQol five-dimension health utility index (five-level edition) from baseline (0.35) to 2 months (0.83) ( P = 0.023). One serious adverse event was reported in the VATS arm. Conclusions This is the first multicenter RCT of early IET versus early surgery in pleural infection. Despite the logistical challenges posed by the coronavirus disease (COVID-19) pandemic, the study met its predefined feasibility criteria, demonstrated potential shortening of length of stay with early surgery, and signals toward earlier resolution of pain and a shortened recovery with IET. The study findings suggest that a definitive phase III study is feasible but highlights important considerations and significant modifications to the design that would be required to adequately assess optimal initial management in pleural infection.The trial was registered on ISRCTN (number 18,192,121).

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Section: Discussionmentioning

confidence: 99%

Early Video-assisted Thoracoscopic Surgery or Intrapleural Enzyme Therapy in Pleural Infection: A Feasibility Randomized Controlled Trial. The Third Multicenter Intrapleural Sepsis Trial—MIST-3

Bedawi,

Stavroulias,

Hedley

et al. 2023

Am J Respir Crit Care Med

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“…86 The Aspiration versus Chest Tube (ACTion) trial demonstrated the feasibility of TT in 10 patients with complicated parapneumonic effusion without significant loculations. 87 This approach will need evaluation in larger studies.…”

Section: Nonsurgical Management Of Parapneumonic Effusion Fitzgerald ...mentioning

confidence: 99%

Expert Review on Nonsurgical Management of Parapneumonic Effusion: Advances, Controversies, and New Directions

Fitzgerald

Polverino

Waterer

2023

Semin Respir Crit Care Med

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Parapneumonic effusion and empyema are rising in incidence worldwide, particularly in association with comorbidities in an aging population. Also driving this change is the widespread uptake of pneumococcal vaccines, leading to the emergence of nonvaccine-type pneumococci and other bacteria. Early treatment with systemic antibiotics is essential but should be guided by local microbial guidelines and antimicrobial resistance patterns due to significant geographical variation. Thoracic ultrasound has emerged as a leading imaging technique in parapneumonic effusion, enabling physicians to characterize effusions, assess the underlying parenchyma, and safely guide pleural procedures. Drainage decisions remain based on longstanding criteria including the size of the effusion and fluid gram stain and biochemistry results. Small-bore chest drains appear to be as effective as large bore and are adequate for the delivery of intrapleural enzyme therapy (IET), which is now supported by a large body of evidence. The IET dosing regimen used in the UK Multicenter Sepsis Trial -2 has the most evidence available but data surrounding alternative dosing, concurrent and once-daily instillations, and novel fibrinolytic agents are promising. Prognostic scores used in pneumonia (e.g., CURB-65) tend to underestimate mortality in parapneumonic effusion/empyema. Scores specifically based on pleural infection have been developed but require validation in prospective cohorts.

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“…The ACTion trial (Aspiration versus Chest Tube drainage for pleural infectION), which is a feasibility study that randomised 10 patients with pleural infection to TT or chest tube insertion, with five patients in each arm, showed that the TT arm had a significantly shorter overall mean± sd hospital stay (5.4±5.1 days) compared to the chest tube control group (13±6.0 days; p=0.04) [ 57 ]. There was no difference in the total number of pleural procedures required per patient among both groups.…”

Section: Management Of Pleural Infectionmentioning

confidence: 99%

Diagnosis and management of pleural infection

Elsheikh,

Bhatnagar,

Rahman

2023

Breathe

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Pleural infection remains a medical challenge. Although closed tube drainage revolutionised treatment in the 19th century, pleural infection still poses a significant health burden with increasing incidence. Diagnosis presents challenges due to non-specific clinical presenting features. Imaging techniques such as chest radiographs, thoracic ultrasound and computed tomography scans aid diagnosis. Pleural fluid analysis, the gold standard, involves assessing gross appearance, biochemical markers and microbiology. Novel biomarkers such as suPAR (soluble urokinase plasminogen activator receptor) and PAI-1 (plasminogen activator inhibitor-1) show promise in diagnosis and prognosis, and microbiology demonstrates complex microbial diversity and is associated with outcomes. The management of pleural infection involves antibiotic therapy, chest drain insertion, intrapleural fibrinolytic therapy and surgery. Antibiotic therapy relies on empirical broad-spectrum antibiotics based on local policies, infection setting and resistance patterns. Chest drain insertion is the mainstay of management, and use of intrapleural fibrinolytics facilitates effective drainage. Surgical interventions such as video-assisted thoracoscopic surgery and decortication are considered in cases not responding to medical therapy. Risk stratification tools such as the RAPID (renal, age, purulence, infection source and dietary factors) score may help guide tailored management. The roles of other modalities such as local anaesthetic medical thoracoscopy and intrapleural antibiotics are debated. Ongoing research aims to improve outcomes by matching interventions with risk profile and to better understand the development of disease.

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A feasibility randomised trial comparing therapeutic thoracentesis to chest tube insertion for the management of pleural infection: results from the ACTion trial

Cited by 5 publications

References 20 publications

Early Video-assisted Thoracoscopic Surgery or Intrapleural Enzyme Therapy in Pleural Infection: A Feasibility Randomized Controlled Trial. The Third Multicenter Intrapleural Sepsis Trial—MIST-3

Early Video-assisted Thoracoscopic Surgery or Intrapleural Enzyme Therapy in Pleural Infection: A Feasibility Randomized Controlled Trial. The Third Multicenter Intrapleural Sepsis Trial—MIST-3

Expert Review on Nonsurgical Management of Parapneumonic Effusion: Advances, Controversies, and New Directions

Diagnosis and management of pleural infection

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