The Pleural Infection Longitudinal Outcome Study

Not Applicable

Completed

• Conditions: Pleural Infection; Respiratory; Pleural condition, unspecified

• Registration Number: ISRCTN50236700
• Lead Sponsor: niversity of Oxford (UK)

Brief Summary

2020 results in https://pubmed.ncbi.nlm.nih.gov/32675200/ (added 10/12/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-05-20
• Study Completion: 2017-10-31
• Last Update Posted: 5 July 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 546

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)

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> The primary outcome of this study is the capability of the prediction score (RAPID) to predict mortality from pleural infection at 3 months.<br><br> 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.<br>

Secondary Outcome Measures

Name	Time	Method
<br> The secondary outcomes of this study are the capability of baseline clinical indices and the prediction score (RAPID) to predict the following:<br> 1. Mortality from pleural infection at 12 months<br> 2. Duration of hospital (in-patient) stay<br> 3. Necessity for surgical fluid drainage over 12 months<br> 4. Failure of medical treatment<br> 5. Residual lung function impairment at 3 months<br>