REDUCE 2
Research type
Research Study
Full title
A Feasibility Study Evaluating the Efficacy of Indwelling Pleural Catheters Plus Sclerosant in Persistent Symptomatic Pleural Effusions Secondary to Heart Failure
IRAS ID
276041
Contact name
Nick Maskell
Contact email
Sponsor organisation
North Bristol NHS Trust
Duration of Study in the UK
2 years, 3 months, 1 days
Research summary
REDUCE 2 is part of an effort to determine the best way of managing recurrent fluid build-up around the lungs (a pleural effusion) caused by problems with the heart that cannot be managed with medications alone.
The current standard method for managing this fluid build-up is to remove the fluid using a needle and syringe. This procedure is known as a therapeutic aspiration. Therapeutic aspirations are generally performed as often as indicated by a patient’s symptoms.
An alternative method is to insert an Indwelling Pleural Catheter (IPC) which is a small, soft rubber tube that is placed into the chest wall. This remains in for as long as required and allows the fluid to be drained regularly in patient’s home, without the use of any needles. In some patients, this process will cause the fluid to ‘dry up’ and stop returning. The IPC can be removed at this point. Various techniques have been used in other patient groups to increase the likelihood of the drying up the fluid. Two successful techniques are injecting a mixture containing medical grade talc into patients’ IPCs, and using daily drainage of the IPC instead of the more usual 2-3 times a week.
In REDUCE 2, patients with recurrent fluid build-up around the lungs caused by problems with the heart that cannot be managed with medications alone will be randomly allocated to receive standard care (therapeutic aspirations) or the combined approach of IPC insertion, talc injection and daily IPC drainage. The study will find out how the combined approach works in clinical practice and how it affects the lives of the patients involved. REDUCE 2 is a feasibility study, which means that it will not prove which method is superior – the results will be used to help inform future research and patient care.
REC name
London - Riverside Research Ethics Committee
REC reference
21/LO/0490
Date of REC Opinion
14 Jul 2021
REC opinion
Favourable Opinion