Pleural Space Saline Irrigation in Addition to Standard Intrapleural Thrombolytic Therapy in Empyema/Complicated Parapneumonic Effusion

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Saline Irrigation

    Procedure/Surgery

    250 cc waves of warmed saline irrigation (up to 2000 cc) through thoracostomy tube on a daily basis

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Saline Irrigation GroupExperimental treatment 1 intervention
Group B: Standard of Care GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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).

Time frame
Approximately 3 days

Secondary outcomes

1

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.

Time frame
Approximately 10 days
2

Thoracostomy tube days

Number of thoracostomy tube days from the time that treatment is initiated

Time frame
Approximately 10 days
3

Number of hospital days

Number of hospital days from the time that treatment is initiated

Time frame
Approximately 14 days
4

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.

Time frame
Approximately 3 days

Other outcomes

Sponsors and contacts

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