About this trial
The purpose of this study is to see if there is any benefit in adding saline irrigation through a chest tube to the standard course of treatment for people diagnosed or suspected of having a pleural space infection.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Purulent pleural fluid versus pleural fluid analysis demonstrating pH <7.2, glucose <60 mg/dL, positive Gram stain, or positive pleural fluid culture versus multiseptated pleural effusion with infection at top of differential diagnosis
Patients initiating intrapleural lytic therapy under the care of the Interventional Pulmonary consult service at Mayo Clinic in Rochester, MN
Disqualifiers
Unwillingness to give informed consent
Patients with known bleeding diathesis
Platelet count <50,000 per μL
INR >2.2 (of note, INR can be allowed to drift down or be reversed pharmacologically prior to initiation of intrapleural lytics/saline)
Trial design
Parallel
Treatments tested in this trial
Saline Irrigation
Procedure/Surgery250 cc waves of warmed saline irrigation (up to 2000 cc) through thoracostomy tube on a daily basis
Treatment groups
Trial outcomes
Primary outcomes
Adequate pleural space evacuation
Number of intrapleural fibrinolytic doses to achieve adequate pleural space evacuation (defined as \<=2.5 cm separation between parietal and visceral pleural layers on bedside ultrasound or no more than small residual effusion on clinically-directed CT chest imaging).
Secondary outcomes
Need for additional interventions
Number of additional interventions to achieve satisfactory pleural space evacuation, such as additional paired lytics beyond 6 doses, ipsilateral thoracentesis, additional ipsilateral thoracostomy tube placement, surgical intervention, or discharge with an empyema tube in situ.
Thoracostomy tube days
Number of thoracostomy tube days from the time that treatment is initiated
Number of hospital days
Number of hospital days from the time that treatment is initiated
Pain tolerance of pleural space irrigation
Measured using a visual analog scale (VAS) questionnaire that assesses pain experienced during treatment utilizing a scale of 0 to 10, with 10 meaning the worst pain imaginable.
Sponsors and contacts
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