Randomised clinical trial: saline washouts versus standard treatment in complicated parapneumonic pleural effusion or empyema. SCOPE study.

INTERVENTION: Trade Name: Pulmozyme Pharmaceutical Form: Injection INN or Proposed INN: DORNASE ALFA CAS Number: 143831‐71‐4 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 1‐ Trade Name: Urokinase Vedim 100.000 U.I Pharmaceutical Form: Injection INN or Proposed INN: Urikinase Vedim CAS Number: 9039‐53‐6 Other descriptive name: UROKINASE Concentration unit: IU/ml international unit(s)/millilitre Concentration type: equal Concentration number: 50000‐ Trade Name: Salina Fisiológica Grifols 0,9% Solución para perfusión Cloruro de sodio Pharmaceutical Form: Injection INN or Proposed INN: Sodio Cloruro CAS Number: 7647‐14‐5 Other descriptive name: SODIUM CHLORIDE Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 0.9‐ CONDITION: Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] ‐ Therapeutic techniques [E02] Treatment of complicated parapneumatic pleural effusion or empyema PRIMARY OUTCOME: ; Secondary Objective: compare in all three groups:; The size of the pleural effusion 3 and 6 days after intrapleural drainage placement, the need for new pleural drainage or thoracic surgery, the average stay and death or side effects.; Main Objective: To assess the reduction in the number of days that patients with complicated parapneumatic pleural effusion or empyema require pleural drainage Primary end point(s): Reduction in the number of days patients need pleural drainage Timepoint(s) of evaluation of this end point: Day when the pleural drain is removed SECONDARY OUTCOME: ; Secondary end point(s): The size of the pleural effusion 3 and 6 days after intrapleural drainage placement, the need for new pleural drainage or thoracic surgery,; the average stay; death or side effects.; Timepoint(s) of evaluation of this end point: Day when the pleural drain is removed INCLUSION CRITERIA: 1. Patients over 18 years of age 2. Clinical evidence of infection and purulent pleural fluid (empyema) or with one or more of the following criteria: 1) pH of pleural fluid <7.15 or glucose <40 mg/dL, 2) Gram or positive culture of pleural fluid, or 3) pleural effusion occupying 50% or more of the hemithorax on a chest x‐ray or localized on an imaging test (x‐ray, ultrasound, or CT). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 81 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range