A randomised controlled trial of the feasibility of early administration of clot-busting medication through a chest tube versus early surgery in pleural infectio

Not Applicable

Completed

• Conditions: Acute respiratory infection, pleural infection; Respiratory

• Registration Number: ISRCTN18192121
• Lead Sponsor: niversity of Oxford

Brief Summary

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37820359/ (added 12/10/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-30
• Study Completion: 2021-12-31
• Last Update Posted: 23 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Current inclusion criteria as of 02/03/2021:

1. A clinical presentation compatible with pleural infection AND
2. A pleural collection with a chest drain in situ
3. Has pleural fluid requiring drainage which is either:
3.1 Purulent or
3.2 Gram stain positive or
3.3 Culture positive or
3.4 Acidic with a pH < 7.2 or
3.5 Low pleural fluid glucose (< 2mmol / L) in the absence of accurate pH measurement or
4. Residual collection/ongoing sepsis after 24h standard care
5. Willing and able to give written informed consent

_____

Previous inclusion criteria:

1. A clinical presentation compatible with pleural infection AND
2. Has pleural fluid requiring drainage which is either:
2.1 Purulent or
2.2 Gram stain positive or
2.3 Culture positive or
2.4 Acidic with a pH < 7.2 or
2.5 Low pleural fluid glucose (< 2mmol / L) in the absence of accurate pH measurement or
2.6 Septated pleural fluid on ultrasound which is likely secondary to pleural infection (on the basis of local investigator view).
3. Able to give written informed consent

Exclusion Criteria

Current exclusion criteria as of 02/03/2021:

1. Age < 18 years
2. Pleural collection not ameanable to chest tube drainage
3. Chest tube already in place for >= 72 hours
4. Has previously received intra-pleural fibrinolytics and /or DNase for this empyema
5. Has a known sensitivity to DNase or tissue plasminogen activator
6. Has had a previous pneumonectomy on the side of infection
7. Pregnant or lactating
8. Estimated survival less than three months from a different pathology to this empyema, (e.g. metastatic lung carcinoma)

_____

Previous exclusion criteria:

1. Age < 18 years
2. Previously received intra-pleural fibrinolytics and /or DNase for this empyema
3. Known sensitivity to DNase or tissue plasminogen activator
4. Previous pneumonectomy on the side of infection
5. Pregnant or lactating
6. Estimated survival less than three months from a different pathology to this empyema, (e.g. metastatic lung carcinoma)

Study & Design

• Study Type: Interventional
• Study Design: Not specified