Comparison of Early Pleural Irrigation Strategy With Saline to the Standard of Care for the Management of Complicated Pleural Infections.

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.

Conditions

• Therapy
• Pleural Infections

Interventions

DRUG

intrapleural 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.

PROCEDURE

Standard 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 & Collaborators

• University Hospital, Toulouse

  collaborator OTHER

• Central Hospital Saint Quentin

  collaborator OTHER_GOV

• CRC CHI Creteil France

  collaborator OTHER_GOV

• University Hospital, Tours

  collaborator OTHER

• Centre Hospitalier Universitaire de Nīmes

  collaborator OTHER

• University Hospital, Brest

  collaborator OTHER

• CH Morlaix

  collaborator UNKNOWN

• University Hospital, Caen

  collaborator OTHER

• University Hospital, Rouen

  collaborator OTHER

• University Hospital, Angers

  collaborator OTHER_GOV

• Hospices Civils de Lyon

  collaborator OTHER

• CH Pontoise

  collaborator UNKNOWN

• CH Avignon

  collaborator UNKNOWN

• Centre Hospitalier VALENCIENNES

  collaborator OTHER

• CH Le Havre

  collaborator UNKNOWN

• Tenon Hospital, Paris

  collaborator OTHER

• University Hospital, Bordeaux

  collaborator OTHER

• Centre Hospitalier Argenteuil

  collaborator OTHER

• University Hospital, Strasbourg, France

  collaborator OTHER

• Nantes University Hospital

  collaborator OTHER

• CH Haguenau

  collaborator UNKNOWN

• CHU de Reims

  collaborator OTHER

• Centre Hospitalier Alpes Leman

  collaborator OTHER

• Central Hospital, Nancy, France

  collaborator OTHER

• Centre Hospitalier Universitaire, Amiens

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-13

Primary Completion

2029-05-31

Completion

2029-08-31

Countries

• France

Study Locations