The Pleural Infection Longitudinal Outcome Study
| ISRCTN | ISRCTN50236700 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50236700 |
| Secondary identifying numbers | Version 1.0 20/03/2013 |
- Submission date
- 20/03/2013
- Registration date
- 20/05/2013
- Last edited
- 22/06/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
This observational study aims to determine the capacity of baseline clinical and biological parameters and an associated prediction model (RAPID score) to predict mortality from pleural infection (infection of the membrane that enfolds the lungs).
Who can participate?
Patients diagnosed with a pleural infection will be invited to participate.
What does the study involve?
This study has been specifically designed to collect clinical and biological data - for example, the results of blood tests and pleural fluid analysis, and physical observations such as blood pressure, chest X-rays, chest ultrasound scans, lung function testing - in patients with diagnosed pleural infection. We hope that by analysing these results a diagnostic tool (or prediction score) can be developed that will help doctors in the future identify which patients with pleural infection are at higher or lower risk of serious problems or complications. This will hopefully help doctors choose the best treatment options for their patients.
What are the possible benefits and risks of participating?
We hope that every patient in the study will benefit, as normal, from the treatment they receive for their pleural infection as well as the opportunity for regular and continued follow-up appointments and assessments. Participation in the study will not however entitle patients to receive any specific or specialist treatment that they might not otherwise have access to. When the study is completed, we hope that the information collected from those individuals who choose to participate will help us to improve the treatment of patients with pleural infection in the future. Pleural infection itself and the different methods of treating it have their own associated risks and complications, but none of these are affected by participation in this study. Patients will have at least three chest x-rays during their participation, although many of these would need to be done whether you were in the study or not. There are some theoretical health risks from excessive radiation exposure, but chest x-rays are considered one of the safest tests as the dose from one is only equivalent to around four days' worth of normal background radiation.
Where is the study run from?
The study is being led and co-ordinated by the Oxford Respiratory Trials Unit based at the Churchill Hospital, Oxford, United Kingdom.
When is the study starting and how long is it expected to run for?
In total, 500/600 patients from hospitals around the world will participate in this study over an approximate three year period starting in 2013.
Who is funding the study?
Medical Research Council (UK).
Who is the main contact?
Mrs Emma Hedley
emma.hedley@ouh.nhs.uk
Contact information
Scientific
Oxford Respiratory Trials Unit
Oxford Centre for Respiratory Medicine
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LE
United Kingdom
| emma.hedley@ouh.nhs.uk |
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The Pleural Infection Longitudinal Outcome Study: an observational cohort study |
| Study acronym | PILOT |
| Study objectives | An observation study to ascertain the capacity of baseline clinical and biological parameters and an associated prediction model (RAPID score) to predict mortality from pleural infection at 3 months. |
| Ethics approval(s) | NRES Committee South Central - Oxford B, 11/07/2013, REC ref: 13/SC/0204 |
| Health condition(s) or problem(s) studied | Pleural Infection |
| Intervention | Demographics, details of clinical history and past medical history, drug history including antibiotic use within the last 4 weeks and baseline clinical observations, as recorded in normal clinical care. Baseline blood parameters (e.g. full blood count, inflammatory markers, renal function) and measurement of pleural fluid parameters (protein, glucose, LDH and pH if not purulent fluid, standard pleural fluid microbiology), chest X-ray and 10mL (0.3floz) of blood and 20mL (0.6floz) of pleural fluid will be obtained at enrolment into the study and stored in individual local centres. Patients will be followed up at 3 and 12 months post trial entry. |
| Intervention type | Other |
| Primary outcome measure | The primary outcome of this study is the capability of the prediction score (RAPID) to predict mortality from pleural infection at 3 months. The PILOT study is intended to ascertain the capacity of baseline clinical and biological parameters and an associated prediction model (RAPID score) to predict key clinical outcomes including mortality from pleural infection. These include renal indices, age, purulence of pleural fluid, infection source and albumin measured at baseline. |
| Secondary outcome measures | The secondary outcomes of this study are the capability of baseline clinical indices and the prediction score (RAPID) to predict the following: 1. Mortality from pleural infection at 12 months 2. Duration of hospital (in-patient) stay 3. Necessity for surgical fluid drainage over 12 months 4. Failure of medical treatment 5. Residual lung function impairment at 3 months |
| Overall study start date | 01/05/2013 |
| Completion date | 31/10/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 550 |
| Total final enrolment | 546 |
| Key inclusion criteria | Adult patients, both male and female, aged 18 years or over with pleural infection as diagnosed by standard and internationally-accepted criteria as follows: 1. A clinical presentation compatible with pleural infection, AND 2. A pleural fluid collection that may or (rarely, according to clinical judgement) may not require drainage that meets at least one or more of the following criteria: 2.1. Purulent 2.2. Gram stain positive for bacteria 2.3. Bacterial culture positive 2.4. Acidic with a pH <7.2 2.5. Low pleural fluid glucose <3mmol/L (<40mg/dL) 2.6. CT evidence of pleural infection (consolidation of underlying lung with enhancing pleural collection on contrast-enhanced CT) |
| Key exclusion criteria | 1. Age <18 years 2. No pleural fluid available for analysis 3. Previous pneumonectomy on the side of pleural infection 4. Expected survival <3 months due to co-morbid disease 5. Inability to give informed consent |
| Date of first enrolment | 01/05/2013 |
| Date of final enrolment | 01/01/2017 |
Locations
Countries of recruitment
- Australia
- Belgium
- England
- Singapore
- United Kingdom
- United States of America
Study participating centre
OX3 7LE
United Kingdom
Sponsor information
University/education
Oxford University Hospitals NHS Trust
Joint Research Office
Block 60
Churchill Hospital
Oxford
OX3 7LE
England
United Kingdom
| ctrg@admin.ox.ac.uk | |
| Website | http://www.ox.ac.uk/ |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 26/11/2020 | 10/12/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
22/06/2021: PubMed address added.
10/12/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
09/04/2018: Overall trial end date was changed from 01/01/2017 to 31/10/2017.
