Initial Management of Pleural infection: Aspiration vs Chest Tube (IMPACT) trial
Management of pleural infection
This study is a prospective, multi-centre randomised controlled study with internal pilot and embedded antibiotic pharmacokinetic (PK) study of adult patients hospitalised with pleural infection. Patients are randomised to therapeutic thoracentesis (TT) or chest tube insertion as the initial pleural procedure to drain the infected pleural fluid. At screening, patients will have informed consent and demographics taken and eligibility assessment performed. At baseline, patients will be randomised to either therapeutic thoracentesis or chest tube insertion as the initial pleural procedure to drain the infected pleural fluid. They will then have their medical, medication, Radiology results (chest x-ray and pleural ultrasound), RAPID score (a baseline severity score) and lab tests recorded. At baseline, patients will also have their intervention performed, Patient reported outcomes, EQ-5D and VAS questionnaires completed and if consented to, Blood and Pleural fluid sample collected. Following screening, baseline assessment and randomisation there will be trial visits at Day 7 and Day 90. The focus of these will be the collection of clinical information to inform primary and secondary outcomes. Whilst patients are having pleural procedures (either with TT or chest tube), pleural fluid and or samples, may be collected and stored for antibiotic analysis. This will be optional for both study sites and patients.
Hospitalised adult patients with a clinical presentation consistent with pleural infection AND requiring initial pleural fluid drainage based on one of the following parameters: 1. Pleural fluid pH <=7.2 2. Pleural LDH >=900 3. Pleural fluid glucose <=4.0 mmol/L (or 72 mg/dl) 4. Pleural septations/loculation on ultrasound 5. Evidence of pleural infection on CT 6. Pleural effusion occupying >50% of hemithorax on chest radiograph 7. Age >= 16 years
1. Excessive bleeding risk in view of the treating clinician 2. Previous pneumonectomy, chest tube/drain, indwelling catheter or recent surgery on side of current pleural infection 3. RAPID score (if calculable) >5 (indicating a high risk of mortality within 3 months) 4. Enrolment onto another study where the burden on the participant will be too high if they are enrolled onto both. Or if the enrolment onto both would compromise one or both of the study’s objectives. To be decided on a case-by-case basis.