Pleural Infection Trial (PIT-1)

A randomised controlled pilot study comparing intrapleural saline irrigation with simple tube drainage in the management of pleural infection

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN21646859

Enrollment

Registered

2012-05-22

Start date

2009-11-23

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pleural infection Respiratory Pyothorax with fistula

Interventions

Patients will undergo blood tests at baseline and daily during the trial. They will receive antibiotics for pleural infection as per hospital guidelines and will have a 12-14Fr chest tube inserted as

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Clinical presentation consistent with pleural infection requiring chest tube drainage 2. Pleural fluid is: 2.1. Purulent 2.2. Gram stain or culture positive 2.3. pH >7.2

Exclusion criteria

Exclusion criteria: 1. Inability to give informed written consent 2. Pregnancy or lactation 3. Age 14F already placed or drain placed >72 hours ago

Design outcomes

Primary

Measure	Time frame
Change in volume of pleural fluid between 12 - 72 hours and 4-9 days post chest drain placement (before and after 9 irrigations/flushes) as assessed on CT scan with volumetric reporting.	—

Secondary

Measure	Time frame
1. Change in volume of pleural thickening between 12-72 hours and 4-9 days post chest drain placement as assessed on CT with volumetric reporting 2. Percentage of patients requiring surgery at 4 and 12 weeks post trial entry 3. Percentage of patients referred for surgery at 6 days post chest drain placement 4. Length of in-patient hospital stay 5. Mortality at 12 weeks 6. Change in volume of pleural thickening between 12-72 hours and 12 weeks post drain placement as assessed by chest x-ray 7. Change in volume of pleural fluid and thickening between baseline and completion of 9 irrigations/ flushes on chest x-ray 8. Change in loculation score on ultrasound (see annex 4) between 12-24 hours post drain placement and completion of 9 irrigations 9. Time for CRP to fall to 50% of day 0 value 10. Time for CRP to fall to less than 100 mg/l 11. Serial serum and pleural fluid procalcitonin levels with correlation to surgical referral rates and CRP 12. Spirometry (Forced vital capacity) as percentage predicted at 12 weeks (patients with previously diagnosed respiratory disease excluded from this analysis)	—

Measure

Time frame

1. Change in volume of pleural thickening between 12-72 hours and 4-9 days post chest drain placement as assessed on CT with volumetric reporting 2. Percentage of patients requiring surgery at 4 and 12 weeks post trial entry 3. Percentage of patients referred for surgery at 6 days post chest drain placement 4. Length of in-patient hospital stay 5. Mortality at 12 weeks 6. Change in volume of pleural thickening between 12-72 hours and 12 weeks post drain placement as assessed by chest x-ray 7. Change in volume of pleural fluid and thickening between baseline and completion of 9 irrigations/ flushes on chest x-ray 8. Change in loculation score on ultrasound (see annex 4) between 12-24 hours post drain placement and completion of 9 irrigations 9. Time for CRP to fall to 50% of day 0 value 10. Time for CRP to fall to less than 100 mg/l 11. Serial serum and pleural fluid procalcitonin levels with correlation to surgical referral rates and CRP 12. Spirometry (Forced vital capacity) as percentage predicted at 12 weeks (patients with previously diagnosed respiratory disease excluded from this analysis)

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026