Recurrent pleural effusion secondary to heart failure Respiratory
Conditions
Interventions
Potential participants will be identified by clinicians and invited to attend an appointment at their local trial centre with a member of the trial team. During this appointment they will be asked to
Sponsors
North Bristol NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The presence of a recurrent pleural effusion secondary to heart failure that has not responded to medical therapy 2. Sufficient pleural fluid for IPC insertion 3. Symptomatic breathlessness warranting pleural intervention 4. Pleural infection excluded to satisfaction of treating physician 5. Expected survival >12 weeks 6. Written informed consent to trial participation
Exclusion criteria
Exclusion criteria: 1. Age <18 years 2. Known pleural malignancy 3. Pregnancy, lactation or intention to become pregnant 4. Absolute contraindication to IPC insertion or therapeutic aspiration of pleural fluid 5. Previous attempts at ipsilateral pleurodesis 6. Evidence of extensive lung entrapment on chest x-ray or CT, or significant fluid loculation on ultrasound scan, to a level which would normally be a contraindication to attempted talc pleurodesis or IPC insertion. 7. Inability to give informed consent 8. Patient has no access to a telephone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of participants recruited from those who meet the eligibility criteria: the study will be deemed successful if the absolute number recruited is at least 32, and =50% eligible patients are successfully randomised; Timepoint(s): Randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The number of patients with successful pleurodesis at 4 and 12 weeks post intervention. For the purposes of IPC removal, pleurodesis will be defined as the collection of less than, or equal to, 50 ml of pleural fluid on three consecutive occasions, with chest opacification on the side of the IPC less than 25%, as judged by 2 independent clinicians. The x-ray must be taken after the third drainage of 50 ml or less. If a participant (or the district nursing team) feels their fluid volumes have dropped to these levels, they are encouraged to contact the local trial centre for assessment. The local trial team should then see the participant and assess them clinically and with a chest x-ray (see SOP). The appropriate CRF must be completed at this point. If pleurodesis is confirmed the IPC should be removed. Pleurodesis can be identified at any point throughout the study in the IPC/talc arm. In the control arm, pleurodesis will be defined as chest x-ray opacification of less than 25%, with no further pleural interventions required throughout the duration of the study following the initial aspiration. 2. Self-reported quality of life status measured using the EuroQol-5D (EQ-5D) and Minnesota Living with Heart Failure Questionnaire (MLHFQ) at baseline, 2 weeks, 4 weeks and 12 weeks 3. Breathlessness measured using self-reported VAS scores at baseline and daily for the subsequent 2 weeks then weekly for the remainder of follow up 4. Chest pain measured using self-reported VAS scores at baseline and daily for the subsequent 2 weeks then weekly for the remainder of follow up 5. Heart failure classification based on limitation of physical activity measured using New York Heart Association (NYHA) class at baseline, 2 weeks, 4 weeks, and 12 weeks 6. The number of drainages/procedures per patient per week and total volume of pleural fluid removed, measured by healthcare professionals recording the volume of each drainage, measured at 12 weeks 7. All-cause mortality measured usi | — |
Countries
England, United Kingdom, Wales
Outcome results
None listed