Intrapleural Fibrinolysis and DNase Versus VATS for the Treatment of Pleural Empyema: a Randomized, Controlled Trial

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Pleura empyema is a frequent disease with a high morbidity and a mortality rate of approximately 15%. Pleura empyema is characterized by the passage of three stages (I - III). The aim of treating the disease is to remove the infection and provide fully expansion of the lung. The initial treatment at the early stage of the disease (stage I) is simple drainage. In clinical practice, stages II and III are treated alike. Current standard treatment for these stages is drainage with ultrasound (ULS) -guided pigtail. Simultaneously with drainage, an intrapleural fibrinolyticum can be given. A potential better alternative is surgery in terms of Video Assisted Thoracoscopic Surgery (VATS). The theoretical advantage of early surgery is that patients undergo rapid, definitive treatment. Furthermore, surgery can ensure optimal drain placement. How best to treat these patients (drainage or surgery) is still under clinical evaluation and depends to a great extent on local clinical practice. It is only to a limited extent based on scientific evidence. The aim of this study is to determine if there is a difference in outcome in patients diagnosed with stage II and stage III empyema who either receive primary VATS surgery or ULS guided drainage and intrapleural therapy (fibrinolytic (altaplasm) with DNase (Pulmozyne ®)) The primary outcome is Hospitalization time and secondary outcomes is e.g. mortality, health related costs and quality of life. The present study can thus provide new and highly relevant knowledge as well as change the treatment of these patients, both nationally and internationally. It is planned that a total of 184 patients will be included in the project. The study takes place as a collaboration between all four thoracic surgical departments and the major pulmonary medicine departments in Denmark. In addition, the study has international collaborators/consultants who will provide counselling in connection with the study.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 18 years or more on the day of hospitalization

• Must be able to provide informed consent

• Acute hospitalization within the last 48 hours

• Meeting diagnostic criteria for community acquired pleural infection using the following criteria:

‣ A clinical presentation compatible with pleural infection AND

⁃ Has pleural fluid which is either:

• purulent pleural fluid or

∙ gram stain positive or

∙ culture positive or

∙ acidic with pH \< 7.2 or

∙ low pleural fluid glucose (\< 2 mmol/L) in the absence of accurate pH measurement or

∙ septated pleural fluid on ultrasound

Locations
Other Locations
Denmark
Aarhus University Hospital
RECRUITING
Aarhus
Rigshospitalet
NOT_YET_RECRUITING
Copenhagen
Odense University Hospital
RECRUITING
Odense
Contact Information
Primary
Thomas D Christensen, MD, PhD
tdc@clin.au.dk
24778857
Backup
Morten Bendixen, MD, PhD
pinseferie@gmail.com
24778895
Time Frame
Start Date: 2022-10-30
Estimated Completion Date: 2028-10-30
Participants
Target number of participants: 184
Treatments
Experimental: VATS / surgical group
The VATS procedure must be completed as soon as possible and no later than 48 hours after randomisation. The surgery is performed with the patient in a 90 degree sideways position, using general anesthesia. Access is obtained through one to three ports, followed by purification and possibly decortication, and insertion of one pleural drain (sizes 24 - 32F) at the end of surgery. 20 ml Marcain is used as local analgetic and applied at the incision sites or as a nerve block. In the VATS group, suction on drain (- 15 cm H20) is applied in the first day after the procedure. Operator must have relevant training and competencies corresponding to the specialist level within the relevant specialty and be registered and approved by the steering committee.
Active_comparator: Drain and intrapleural therapy group
Pigtail is applied as soon as possible and within 48 hours after randomisation. Drain placement is carried out using ULS. Operators (conductors of the procedure) must have relevant training and competencies corresponding to the specialist level within the relevant specialty and be approved by the steering committee to conduct the procedure. A pigtail catheter (minimum 10F) is inserted. Operator determines the size of drain and whether drain placement is done with one-step or Seldinger technic.~The intrapleural therapy consists of treatment with the following two drugs:~* intrapleural Actilyse® (alteplase) 10 mg twice daily for three days~* intrapleural Pulmozyme® (DNase) 5 mg twice daily for three days
Related Therapeutic Areas
Sponsors
Collaborators: Odense University Hospital, Aalborg University Hospital, Rigshospitalet, Denmark
Leads: Thomas Decker Christensen

This content was sourced from clinicaltrials.gov