Pleural Infections, Therapy
Conditions
Keywords
therapy, pleural infections
Brief summary
Intrapleural enzyme therapy (IET) is regarded by recent guidelines as a "rescue" therapy for managing complicated pleural infections; however, it is associated with significant side effects, including pleural bleeding, pain, and fever. Pleural irrigation with saline may serve as an alternative, yet evidence supporting its effectiveness is limited to a single small- scale, single-center randomized trial. The objective of the study is to compare the risk of treatment failure at 30 days (defined as a composite outcome that includes death, the need for thoracic surgery, or additional intrapleural enzyme therapy) between an early pleural irrigation strategy and standard care for complicated pleural infections.
Interventions
DRUGintrapleural irrigation
500 mL bags of 0.9% sodium chloride will be administered into the thoracic cavity via the chest tube using a three way tap and gravity (no infusion pump or pressure). The infusion is followed by free drainage with thoracic suction (up to -20 cmH2O). This process will occur two times daily for a total of 6 irrigations.
PROCEDUREStandard care
Standard care includes pleural drainage with 20 mL 0.9% sodium chloride flushes administered two times daily for 3 days to maintain tube patency. Thoracic suction (up to -20 cmH2O) will be applied to chest tubes.
Sponsors
Centre Hospitalier Universitaire, Amiens
University Hospital, Toulouse
Central Hospital Saint Quentin
CRC CHI Creteil France
University Hospital, Tours
Centre Hospitalier Universitaire de Nīmes
University Hospital, Brest
CH Morlaix
University Hospital, Caen
University Hospital, Rouen
University Hospital, Angers
Hospices Civils de Lyon
CH Pontoise
CH Avignon
Centre Hospitalier VALENCIENNES
CH Le Havre
Tenon Hospital, Paris
University Hospital, Bordeaux
Centre Hospitalier Argenteuil
University Hospital, Strasbourg, France
Nantes University Hospital
CH Haguenau
CHU de Reims
Centre Hospitalier Alpes Leman
Central Hospital, Nancy, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults (≥18 years old) capable of fully understanding the study; * Complicated pleural infection (macroscopically purulent fluid, positive for bacteria on Gram's staining, positive on culture for bacterial infection, loculated effusion, pH \<7.2, great abundance) leading to thoracic drainage; * Initial ultrasound evaluation to estimate pleural fluid abundance and detect fibrinous septation; * Social security affiliation * Written informed consent * Highly effective contraceptive methods for women of childbearing age include: Combined hormonal contraception (estrogen and progestogen) associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device; hormone- releasing intrauterine system; bilateral occlusion of the Fallopian tubes; vasectomized partner; sexual abstinence
Exclusion criteria
* Tuberculous pleural effusions; * Previous treatment with intrapleural fibrinolytic agents (urokinase, streptokinase, alteplase, or DNase) or intrapleural saline lavage; * Previous thoracic surgery for pleural infection; * Contraindications to auxiliary treatments, to fibrinolysis or surgery as well as to procedures such as drainage and lavage; * Pregnancy or lactation; * Expected survival of less than 3 months; * Thoracic drainage since more than 24h; * Patient deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision); * Inability to give informed written consent; * Participation in another clinical trial; * Patient being a relative of the investigator or any member of the team directly involved in the study, including assistant physicians, pharmacists, nurses, and coordinators
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of treatment failure | at 30 days | Treatment failure, defined as a composite outcome that includes death, the need for thoracic surgery, or additional intrapleural enzyme therapy. This criterion will be assessed at 30 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Volume of pleural fluid drained from randomization | at day 3 | Volume of pleural fluid drained from randomization to day 3 |
| Incidence of adverse events | at 90 days | Incidence of serious and non-serious adverse events, including fever, allergic reactions, bleeding, and chest tube obstruction |
| Intra-hospital mortality | at 30 days | — |
| Rate of thoracic surgery | at 30 days | Rate of thoracic surgery |
| Rate of additional intrapleural enzyme therapy | at 30 days | Rate of additional intrapleural enzyme therapy |
| Length of hospital stay | at 90 days | Length of hospital stay |
| Change in the area of pleural opacity | at day 3 | Change in the area of pleural opacity, measured as the percentage of the ipsilateral hemithorax occupied by effusion on chest radiography from randomization to day 3; |
| Presence of a restrictive ventilatory defect | at day 90 | Presence of a restrictive ventilatory defect, defined as total lung capacity \< 80% of predicted values |
| Assessment of pain using a numeric pain scale | at 90 days | Assessment of pain using a numeric pain scale |
| valuation of the prognostic performance of the RAPID score | at day 0 | valuation of the prognostic performance of the RAPID score |
Countries
France
Contacts
CONTACTDamien BASILLE, Pr
Outcome results
None listed