Pleural infection Respiratory
Conditions
Interventions
Intervention arm:
The intervention in this study is treatment driven by the baseline RAPID score (post-randomisation). Patients with a higher RAPID score (and thus higher predicted mortality) will be
full blood count, CRP (C- reactive protein), liver and renal profile, ultrasound scan and chest x ray.
5. All patients will receive a 24-hour contact number (to the study fellow) who can be contacted
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: Adults with confirmed pleural infection requiring admission to hospital with ALL of the following: 1. A clinical presentation compatible with pleural infection or infective illness 2. A pleural collection on radiology (CXR, ultrasound or CT) with a chest drain in situ or planned 3. Pleural fluid features diagnostic of infection which is either: 3.1. Purulent or 3.2. Gram positive or 3.3. Culture positive (pleural fluid or biopsy) or 3.4. Acidic with a pH<7.2 or 3.5. Low pleural fluid glucose <4.4 mmol/L or 72mg/dL(non-diabetic) or LDH = 900 iu/L OR 3.6. (Non-fluid criteria) – CT findings suggestive of pleural infection (pleural enhancement) or pleural fluid septations on thoracic ultrasound 4. Willing and able to give written informed consent
Exclusion criteria
Exclusion criteria: The participant may not enter the study if ANY of the following apply: 1. Age less than 18 years 2. Previous pneumonectomy on the infected side 3. Pleural collection not amenable to chest tube drainage 4. Has previously received intra-pleural fibrinolytics and /or DNase for this empyema (ipsilateral and deemed by the clinical team to be the same, ongoing infection) 5. Has a known sensitivity or allergy to DNase or tissue plasminogen activator 6. Participants who are pregnant or lactating 7. Patients with pleural infection and an estimated survival period of less than three months due to an unrelated pathological condition,such as metastatic lung carcinoma. 8. Participant who are unable to give informed consent (lacking capacity)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The feasibility of recruitment, data collection and acceptability of the participants and of healthcare professionals of randomisation, assessed using: 1. Recruitment, retention rate, the proportion of participants screened who consented to be randomised and who consented to be interviewed, data completeness/availability and participant completion assessed at recruitment completion. 2. Semi- structured interviews with a proportion of the randomised participants and healthcare professionals at 4 to 6 weeks post hospital discharge The primary outcome will be defined as successful if =50% of the eligible patients are willing to be randomised and =50% of the healthcare professionals and participants agreed to take part in the interviews at recruitment completion | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Length of hospital stay strategies: completeness of data regarding the time of the participants staying in hospital over 3 months from randomisation until discharge 2. Mortality rate over 3 months (all cause): proportion of participants who died (all cause) over 3 months post randomisation until the end of the study 3. Need for IET: proportion of participants who required IET post randomisation from time of admission until discharge 4. Need for surgery: proportion of participants who required surgery post randomisation from time of admission until discharge 5. Medical treatment failure: proportion of participants who did not respond to medical treatment (pleural fluid drainage + IET) and required surgery post randomisation from time of admission until discharge 6. Need for repeat intervention and admission: number of participants who need further pleural procedure, e.g. chest drain insertion or therapeutic thoracocentesis and proportion of the participants who required re admission to hospital until the end of the study 7. Duration of antibiotics: completeness of data regarding the use of antibiotics from day of starting antibiotics up to 6 weeks post discharge 8. Time to complete recovery and return to normal function measured using SF36 at 4- and 12-weeks post randomisation 9. Health related quality of life measured using EQ5D 5l questionnaire at baseline, 2-, 4- and 12-weeks post randomisation 10. Breathlessness and pain measured using 100 mm VAS score post randomisation and until discharge from hospital 11. Feasibility of delivering the intervention arm (RAPID driven arm) measured using time of failure of medical treatment to surgery (VATS, thoracotomy) or time from ICD insertion to IET at end of the study 12. Healthcare utilisation: number of pleural procedures and days in hospital post randomisation during hospital stay 13. The pattern of computed tomography of the chest (CT chest) in pleural infection to assess for consolidation during hospital stay 14. Ra | — |
Countries
England, United Kingdom
Contacts
Public ContactAlguili Elsheikh
Outcome results
None listed