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

ISRCTN ISRCTN66354436
DOI https://doi.org/10.1186/ISRCTN66354436
Secondary identifying numbers 17127
Submission date
15/07/2015
Registration date
15/07/2015
Last edited
07/04/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Some people with diseases affecting the function of the heart or liver can collect fluid in the space between the lung and the chest wall (a pleural effusion). The amount of fluid that builds up varies. If the amount of large enough, it can press on the lung, stopping it from expanding fully as the patient breathes and causing breathlessness. Treatment varies greatly as it largely depends on the underlying cause. However, there is limited guidance on how to treat the effusion directly. This study will compare two treatment methods: removal of the fluid with a needle and syringe as and when needed (control) or insertion of an indwelling pleural catheter through which fluid can be removed in the patients home by means of vacuum filled bottles, usually by district nurses.

Who can participate?
Adults (at least 18) with a pleural effusion resulting from heart or liver disease.

What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 are treated using the needle and syringe method. Those in group 2 are treated via the pleural catheter method. Levels of breathlessness, quality of life and the cost and complications of treatment are then compared between the two groups.

What are the possible benefits and risks of participating?
All patients in the trial will have fluid taken off from around their lungs which should improve their breathing. Both treatments have some potential risks, including bleeding, infection or discomfort. We will limit these by making sure patient’s blood is clotting normally before any procedure, making sure that procedures are done in a clean environment with clean equipment and using a numbing injection before doing any procedure and using pain-killers after the procedure if patients have any pain. Patients will have regular contact with study doctors to ensure that any problems are picked up as early as possible. Patients with fluid around the lung often need chest x-rays to monitor the fluid, however patients in this study will require two additional chest X-rays, at the beginning of the trial and at the 12 week follow up visit. There is a small theoretical risk with this extra radiation; however chest x-rays are associated with a low level of radiation. Two X-rays are equivalent to one and a half weeks of background radiation in the UK.

Where is the study run from?
The lead centre for this study is North Bristol NHS Trust. We aim to run the trial from a total of 11 centres in England. Centres will be chosen on the basis of whether they have experience with this sort of trial and have the access to the right specialists and procedures.

When is the study starting and how long is it expected to run for?
January 2015 to August 2016

Who is funding the study?
CareFusion Corporation

Who is the main contact?
Prof Nick Maskell
Nick.Maskell@bristol.ac.uk

Contact information

Prof Nick Maskell
Public

Southmead Hospital
Southmead Road
Westbury-On-Trym
Bristol
BS10 5NB
United Kingdom

ORCiD logoORCID ID 0000-0002-1276-6500

Study information

Study designRandomised; Interventional; Design type: Treatment
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleA randomised controlled trial evaluating the efficacy of indwelling pleural catheters in persistent non-malignant symptomatic pleural effusions
Study acronymREDUCE
Study objectivesThis study aims to compare two methods to treat pleural effusion; removal of the fluid with a needle and syringe as and when needed (control) or insertion of an indwelling pleural catheter through which fluid can be removed in the patients home by means of vacuum filled bottles.
Ethics approval(s)NRES Committee South West - Central Bristol, 01/05/2015, ref: 14/SW/0075
Health condition(s) or problem(s) studiedTopic: Respiratory disorders; Subtopic: Respiratory (all Subtopics); Disease: Respiratory
Intervention1. 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
Intervention typeOther
Primary outcome measureChange in breathlessness (VAS score); Timepoint(s): Change to VAS over 12 week trial period
Secondary outcome measures1. 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
Overall study start date09/01/2015
Completion date31/08/2017

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsPlanned Sample Size: 86; UK Sample Size: 86; Description: Anticipated 8% loss to follow up.
Total final enrolment68
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/04/2015
Date of final enrolment01/04/2017

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centres

Southmead Hospital (lead centre)
Southmead Road
Westbury-On-Trym
Bristol
BS10 5NB
United Kingdom
Medway NHS Foundation Trust
Windmill Rd
Gillingham
ME7 5NY
United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London
SE1 7EH
United Kingdom
Cambridge University Hospitals
Cambridge
CB2 0QQ
United Kingdom
South Tees Hospitals NHS Foundation Trust
Middlesbrough
TS4 3BW
United Kingdom
North Tees and Hartlepool Hospitals NHS Foundation Trust
Middlesbrough
TS1 98PE
United Kingdom
Oxford University Hospitals NHS Trust
Oxford
OX3 9DU
United Kingdom

Sponsor information

North Bristol NHS Trust
Hospital/treatment centre

Research & Innovation
Floor 3 Learning & Research Building
Southmead Hospital
Bristol
BS10 5NB
England
United Kingdom

ROR logo "ROR" https://ror.org/036x6gt55

Funders

Funder type

Industry

CareFusion Corporation

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planFollowing completion of the study data from all centres will be analysed and published as soon as reasonably possible. Data will be submitted to a peer-reviewed medical journal within 1 year of trial completion for publication.
IPD sharing planNot added at the time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 24/02/2022 07/04/2022 Yes No
HRA research summary 28/06/2023 No No

Editorial Notes

07/04/2022: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.