Topic: Respiratory disorders
Conditions
Interventions
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 ba
Sponsors
North Bristol NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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 & Female 8. Lower Age Limit 18 years
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in breathlessness (VAS score); Timepoint(s): Change to VAS over 12 week trial period | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, United Kingdom
Contacts
Public ContactNick Maskell
Outcome results
None listed