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

orth Bristol NHS Trust0 个研究点目标入组 68 人开始时间: 2015年7月15日最近更新: 2022年4月19日

适应症

试验速览

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

•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

发起方

orth Bristol NHS Trust