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

INTERVENTION: 1. Insertion of indwelling pleural catheter at randomisation, three times weekly drainage for 2 weeks then drainage as frequently as clinically required 2. Therapeutic aspiration at baseline and further therapeutic aspirations as clinically required Follow Up Length: 3 month(s); Study Entry : Registration only CONDITION: Topic: Respiratory disorders; Subtopic: Respiratory (all Subtopics); Disease: Respiratory ; Respiratory PRIMARY OUTCOME: Change in breathlessness (VAS score); Timepoint(s): Change to VAS over 12 week trial period SECONDARY OUTCOME: 1. Adverse events related to trial intervention; Timepoint(s): 12 weeks; 2. Albumin levels in patients with liver disease; Timepoint(s): 12 weeks; 3. Cost effectiveness; Timepoint(s): 12 weeks ; 4. Failure of initially randomised treatment; Timepoint(s): 12 weeks; 5. Health related quality of life (EQ‐5D); Timepoint(s): 12 weeks; 6. Hospital visits and bed days; Timepoint(s): 12 weeks; 7. Number of pleural interventions; Timepoint(s): 12 weeks; 8. Pleurodesis; Timepoint(s): 12 weeks; Volume of fluid drained; Timepoint(s): 12 weeks; 9. Volume of fluid drained; Timepoint(s): 12 weeks INCLUSION CRITERIA: 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 & Femal